Erfahrung

Das ARS Team für klinische und Arzneimittelzulassung besteht aus Spezialisten, die seit Jahren in der Branche arbeiten. ARS verfügt über umfangreiche Erfahrung in den Bereichen Onkologie, ZNS, Infektionskrankheiten, Augenheilkunde, Gastroenterologie, Herz-Kreislauf und anderen therapeutischen Bereichen.

Unten sehen Sie einige Beispiele der Erfahrung unseres Unternehmens:

MR – Market Research,
BE/PK - Bioequivalence / Pharmacokinetics,
TE – Therapeutic Equivalence,
MA – Marketing Authorization,
MMCT – Multinational Multicenter Clinical Trial

Allergology

Indication
Stage
Year completed
Product Type
IndicationPersisting and seasonal allergic rhinitis and conjunctivitis; hay fever (pollinosis); urticaria; allergic dermatitis
StageBE/PK
Year completed2014
Product TypeINN - Levocetirizine

Cardiovascular

Indication
Stage
Year completed
Product Type
IndicationPulmonary arterial hypertension
StageBE/PK
Year completedpresent
Product TypeINN - Bosentan
IndicationArterial hypertension, others
StageBE/PK
Year completedpresent
Product TypeINN - Telmisartan
IndicationSymptomatic treatment of intermittent claudication
StagePhase III CT
Year completedpresent
Product TypeINN - Cilostazol
IndicationPrevention of atherothrombotic complications; prevention of atherothrombotic and thromboembolic events, including stroke in atrial fibrillation (atrial fibrillation)
StageBE/PK
Year completedpresent
Product TypeINN - Clopidogrel
IndicationStable angina, chronic heart failure
StageMA
Year completed2015
Product TypeINN - Ivabradine
IndicationArterial hypertension; chronic heart failure; arterial hypertension in children and adolescents
StageMA
Year completed2015
Product TypeINN - Valsartan
IndicationStable angina, chronic heart failure
StageBE/PK
Year completed2015
Product TypeINN - Ivabradine
IndicationArterial hypertension
StageMA
Year completed2015
Product TypeFDC - Losartan + Hydrochlorothiazide
IndicationEdematous syndrome of various origins, arterial hypertension
StageBE/PK
Year completed2014
Product TypeINN - Torasemide
IndicationPrevention of venous thrombosis and embolism in surgical interventions, treatment of unstable angina and myocardial infarction, etc.
StagePhase III CT
Year completed2014
Product TypeBioanalogue - Enoxaparin sodium
IndicationNeuroprotection, improvement of cerebral circulation, peripheral and microcirculation, etc.
StagePreclinical
Year completed2013
Product TypeBotanical drug - Vasoprotective drug
IndicationPrevention of atherothrombotic complications in patients with myocardial infarction, ischaemic stroke, acute coronary syndrome
StageMA
Year completed2013
Product TypeINN - Clopidogrel
IndicationChronic heart failure
StageMA
Year completed2012
Product TypeINN - Bisoprolol
IndicationArterial hypertension, ischemic heart disease, chronic heart failure
StageMA
Year completed2012
Product TypeINN - Nebivolol
IndicationArterial hypertension
StageMA
Year completed2011
Product TypeFDC - Hydrochlorothiazide + Losartan
IndicationArterial hypertension, ischemic heart disease
StageMA
Year completed2011
Product TypeINN - Bisoprolol
IndicationArterial hypertension, ischemic heart disease
StageMA
Year completed2011
Product TypeINN - Nebivolol
IndicationArterial hypertension
StageMA
Year completed2011
Product TypeINN - Indapamide

CNS (neurology, psychiatry)

Indication
Stage
Year completed
Product Type
IndicationEpilepsy with the partial with secondary generalization or not, or generalized tonic-clonic seizures, Lennox-Gastaut syndrome
StageMA
Year completedpresent
Product TypeINN - Topiramate
IndicationAdjunctive therapy in patients with degenerative brain diseases
StagePhase III CT
Year completedpresent
Product TypeBranded pharmaceutical
IndicationAnxiety
StagePhase III CT
Year completedpresent
Product TypeDietary supplement - Sedative
IndicationModerate to severe postoperative pain (within 48 hours after uncomplicated appendectomy, cholecystectomy, herniotomy, herniorraphy or phlebectomy)
StagePhase III CT
Year completedpresent
Product TypeINN - Ketorolac trometamol
IndicationNeuropathic pain, generalized anxiety disorder, fibromyalgia, partial seizures
StageMA
Year completed2016
Product TypeINN - Pregabalin
IndicationNeuropathic pain, epilepsy, fibromyalgia, generalized anxiety disorder
StageBE/PK
Year completed2015
Product TypeINN - Pregabalin
IndicationNeuropathic pain, epilepsy
StageMA
Year completed2013
Product TypeINN - Gabapentin
IndicationModerate and severe depression and its prevention, panic disorder with/without agoraphobia
StageMA
Year completed2013
Product TypeINN - Citalopram
IndicationEpilepsy with the partial with secondary generalization or not, or generalized tonic-clonic seizures, Lennox-Gastaut syndrome
StageMA
Year completed2013
Product TypeINN - Topiramate
IndicationStrong and moderate pain
StageMA
Year completed2013
Product TypeINN - Ketorolac
IndicationPartial seizures with secondary generalization or without in patients with Epilepsy
StageMA
Year completed2012
Product TypeINN - Levetiracetam
IndicationRelieving pain
StageMA
Year completed2011
Product TypeINN - Ketorolac
IndicationAnxiety
StagePreclinical
Year completed2010
Product TypeDietary supplement - Sedative

Dermatology

Indication
Stage
Year completed
Product Type
IndicationAtopic dermatitis
StagePhase III CT
Year completedpresent
Product TypeINN - Pimecrolimus

Gastroenterology

Indication
Stage
Year completed
Product Type
IndicationDuodenal ulcer, gastric ulcer, others
StageBE/PK
Year completedpresent
Product TypeINN - Pantoprazole
IndicationPeptic ulcer and duodenal ulcers, others
StageMA
Year completedpresent
Product TypeINN - Omeprazole
IndicationAcute peptic ulcer and duodenal ulcer, gastroesophageal reflux disease; pathological hypersecretion, incl. the syndrome of Zollinger-Ellison
StageBE/PK
Year completedpresent
Product TypeINN - Rabeprazole Sodium
IndicationErosive reflux esophagitis, peptic ulcer and duodenal ulcer, prevention of relapse of peptic ulcer syndrome Zollinger-Ellison, others
StageBE/PK
Year completedpresent
Product TypeINN - Esomeprazole
IndicationPeptic ulcer and duodenal ulcer, ulcer anastomosis, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome
StageMA
Year completed2015
Product TypeINN - Rabeprazole
IndicationUlcerative colitis, Crohn's disease
StageMA
Year completed2014
Product TypeINN - Mesalazine
IndicationPurgation before radiologic or endoscopic examinations and surgical procedures
StageMA
Year completed2014
Product TypeBranded pharmaceutical
IndicationUlcerative proctosigmoiditis, left-sided ulcerative colitis.
StageMA
Year completed2014
Product TypeINN - Mesalazine
IndicationPeptic ulcer and duodenal ulcer; anastomotic ulcer; gastroesophageal reflux disease (GERD); Zollinger-Ellison syndrome, others
StageBE/PK
Year completed2014
Product TypeINN - Rabeprazole
IndicationChronic constipation, hypo- and intestinal atony; facilitating emptying of the bowel
StagePreclinical
Year completed2013
Product TypeBotanical drug - Laxative drug
IndicationAntiulcer therapy
StageMA
Year completed2012
Product TypeINN - Rebamipide
IndicationAcute duodenal ulcer, gastroesophageal reflux disease (GERD)
StageMA
Year completed2011
Product TypeINN - Rabeprazole
IndicationSpasms of smooth muscles of internal organs
StageMA
Year completed2011
Product TypeFDC - Metamizole sodium + Pitofenone + Fenpiverinium bromide
IndicationSpasm of smooth muscle in diseases of the biliary tract and urinary tract; spasms of smooth muscles of the gastrointestinal tract; spastic colitis, irritable bowel syndrome; dysmenorrhea
StageMA
Year completed2011
Product TypeINN - Drotaverine

General

Indication
Stage
Year completed
Product Type
IndicationN/A
StageMA
Year completed2016
Product TypeWater for injection

Gynecology / Obstetrics / Reproductive Health

Indication
Stage
Year completed
Product Type
IndicationNonspecific vaginitis caused by Candida in the acute stage of the disease
StagePhase III CT
Year completedpresent
Product TypeBranded pharmaceutical
IndicationErectile dysfunction
StageBE/PK
Year completedpresent
Product TypeINN - Sildenafil
IndicationContraception
StageBE/PK
Year completedpresent
Product TypeFDC - Dienogest + Ethinylestradiol
IndicationErectile dysfunction
StageMA
Year completed2016
Product TypeINN - Sildenafil
IndicationAnovulation, controlled ovarian hyperstimulation; stimulation of spermatogenesis in case of azoospermia or oligoasthenospermia
StageMA
Year completed2014
Product TypeBioanalogue - Menotropins
IndicationErectile dysfunction
StagePreclinical
Year completed2014
Product TypeINN - Sildenafil
IndicationHypofunction of sexual glands; ovulation induction due to anovulation or impaired maturation of follicles; gipogonadotropny hypogonadism; delayed puberty caused by a lack of gonadotropic pituitary function; cryptorchidism; others
StagePreclinical
Year completed2013
Product TypeBioanalogue - Choronic Gonadotrophin
IndicationErectile dysfunction
StageBE/PK
Year completed2013
Product TypeINN - Sildenafil
IndicationAnovulation, controlled ovarian hyperstimulation
StageMA
Year completed2013
Product TypeBioanalogue - Urofollitropin
IndicationContraception in women with symptoms of androgenization
StageMA
Year completed2013
Product TypeFDC - Cyproterone + Ethinylestradiol

Hematology / Cardiovascular

Indication
Stage
Year completed
Product Type
IndicationDeep vein thrombosis, pulmonary embolism, coronary artery disease, thrombophlebitis, unstable angina, acute myocardial infarction, atrial fibrillation, disseminated intravascular coagulation
StageMA
Year completed2013
Product TypeBioanalogue - Heparin

Hepatology

Indication
Stage
Year completed
Product Type
IndicationUncomplicated gallstone disease; chronic hepatitis; cholestatic liver disease; nonalcoholic fatty liver disease; alcoholic liver disease; chronic viral hepatitis; biliary dyskinesia; the biliary replace gastritis and reflux esophagitis
StageBE/PK
Year completedpresent
Product TypeINN - Ursodeoxycholic acid
IndicationFatty degeneration of the liver; acute and chronic hepatitis, cirrhosis, liver cell necrosis, hepatic coma and precoma, toxic liver damage; toxemia of pregnancy; pre - and post-operative treatment, especially during operations in the field of hepatobiliary zone; psoriasis (as adjunctive therapy); radiation syndrome
StageMA
Year completed2014
Product TypeINN - Natural phospholipids

Hepatology / Infectious diseases

Indication
Stage
Year completed
Product Type
IndicationChronic hepatitis B, C
StageMA
Year completedpresent
Product TypeBioanalogue - Peginterferon alfa-2b
IndicationChronic hepatitis B, C
StagePhase III CT
Year completed2014
Product TypeBioanalogue - Peginterferon

Immunology

Indication
Stage
Year completed
Product Type
IndicationStrengthening the immune system; as a source of vitamin C; antibiotic therapy of chronic infectious diseases
StageMA
Year completed2011
Product TypeBotanical drug - Immunostimulant

Infectious / Inflammatory diseases

Indication
Stage
Year completed
Product Type
IndicationInfectious and inflammatory diseases: infection of the CNS (meningitis), lower and upper respiratory tracts, urinary tract, bones, joints, skin and soft tissues, pelvic organs, uncomplicated gonorrhea, peritonitis, sepsis, intraabdominal infections, endocarditis, Lyme disease (borreliosis); infection caused by immunodeficiency; prevention of infections after surgery
StagePhase III CT
Year completedpresent
Product TypeFDC - Ceftriaxone + Sulbactam
IndicationInfectious and inflammatory diseases: meningitis, lower and upper respiratory tracts, urinary tract, bones, joints, skin and soft tissues, pelvic organs, uncomplicated gonorrhea, peritonitis, sepsis, intraabdominal infections, endocarditis, Lyme disease (borreliosis); infection caused by immunodeficiency; prevention of infections after surgery
StagePhase III CT
Year completedpresent
Product TypeFDC - Cefotaxime + Sulbactam
IndicationInfectious-inflammatory diseases: pneumonia; complicated infections of skin and soft tissues; uncomplicated infections of skin and soft tissue ; infections not sensitive to vancomycin, caused by Enterococcus faecium, including bacteremia
StageBE/PK
Year completedpresent
Product TypeINN - Linezolid
IndicationPneumonia, appendicitis, peritonitis, pyelonephritis, pyelitis, bacterial meningitis, septicaemia, others
StageMA
Year completed2015
Product TypeINN - Meropenem
IndicationPneumonia, appendicitis, peritonitis, pyelonephritis, pyelitis, bacterial meningitis, septicaemia, others
StageMA
Year completed2015
Product TypeINN - Meropenem
IndicationBacterial infections caused by pathogens susceptible to the FDC: infections of upper and lower respiratory tract; urinary tract infections, infections of the female genital organs, gonorrhea; infections of skin and soft tissues; infections of bones and joints; septic abortion, puerperal sepsis, septicaemia, peritonitis, intraabdominal sepsis, postoperative infection
StageMA
Year completed2015
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationInfectious-inflammatory diseases: meningitis, lower and upper respiratory tract, urinary tract, bones, joints, skin and soft tissues, of pelvic organs; peritonitis, sepsis, endocarditis, gonorrhea, infected wounds and burns, intraabdominal infections, Salmonella, Lyme disease, infections caused by immunodeficiency
StagePreclinical
Year completed2014
Product TypeINN - Cefotaxime
IndicationInfectious-inflammatory diseases: sepsis, meningitis, typhoid fever, salmonellosis, disseminated Lyme borreliosis, infection of abdominal cavity, infections of bones, joints, soft tissues, skin and wound infections; infections in patients with reduced immunity, infections of kidneys and urinary tract, lower and upper respiratory tract infections; urogenital infections
StagePreclinical
Year completed2014
Product TypeINN - Ceftriaxone
IndicationInfectious-inflammatory diseases caused by sensitive to moxifloxacin microorganisms: acute sinusitis; exacerbation of chronic bronchitis; community-acquired pneumonia; infections of skin and soft tissues; complicated intraabdominal infections
StageMA
Year completed2014
Product TypeINN - Moxifloxacin
IndicationInfectious-inflammatory diseases caused by sensitive to ofloxacin by micro-organisms: lower respiratory tract, ENT organs; skin and soft tissues; bones and joints; abdominal and biliary tract; kidneys, urinary tract, prostate gland and urethra; genital and pelvic organs; septicaemia; prevention of infections in patients with impaired immune status
StageMA
Year completed2014
Product TypeINN - Ofloxacin
IndicationInfectious-inflammatory diseases caused by sensitive to Meropenem micro-organisms: lower respiratory infection; intraabdominal infections; infections of urinary tract; infections of skin and soft tissue; bacterial meningitis; septicaemia, infectious-inflammatory diseases of the pelvic organs
StageMA
Year completed2014
Product TypeINN - Meropenem
IndicationInfectious-inflammatory diseases caused by sensitive to moxifloxacin microorganisms: acute sinusitis; chronic bronchitis; pneumonia; infections of skin and soft tissues; complicated intra-abdominal infections; uncomplicated infections of the pelvic organs
StageBE/PK
Year completed2013
Product TypeINN - Moxifloxacin
IndicationInfectious-inflammatory diseases caused by sensitive to moxifloxacin microorganisms: acute sinusitis; chronic bronchitis; pneumonia; infections of skin and soft tissues; complicated intra-abdominal infections; uncomplicated infections of the pelvic organs
StageBE/PK
Year completed2013
Product TypeINN - Moxifloxacin
IndicationInfectious-inflammatory diseases caused by sensitive to levofloxacin by micro-organisms
StageMA
Year completed2011
Product TypeINN - Levofloxacin
IndicationInfectious-inflammatory diseases caused by sensitive to levofloxacin by micro-organisms
StageMA
Year completed2011
Product TypeINN - Levofloxacin

Infectious diseases

Indication
Stage
Year completed
Product Type
IndicationUrinary tract infections: pyelitis, pyelonephritis, cystitis, urethritis
StageMA
Year completedpresent
Product TypeINN - Nitrofurantoin
IndicationHIV-1 infection
StageBE/PK
Year completedpresent
Product TypeINN - Saquinavir
IndicationHIV/AIDS
StageBE/PK
Year completedpresent
Product TypeFDC - Abacavir + Lamivudine + Zidovudine
IndicationDysentery vaccine against Shigella flexneri (bacterial infectious disease)
StagePhase II CT
Year completedpresent
Product TypeVaccine
IndicationHIV-1, hepatitis B
StageBE/PK
Year completedpresent
Product TypeINN - Tenofovir
IndicationHIV/AIDS
StageBE/PK
Year completedpresent
Product TypeINN - Darunavir
IndicationInfectious-inflammatory diseases caused by sensitive to levofloxacin by micro-organisms
StageBE/PK
Year completedpresent
Product TypeINN - Levofloxacin
IndicationSymptomatic therapy of infectious and inflammatory diseases (SARS, influenza), accompanied by high fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing
StageBE/PK
Year completedpresent
Product TypeFDC - Paracetamol + Phenylephrine + Chlorphenamine maleate
IndicationCommunity-acquired and nosocomial bacterial infections caused by susceptible microorganisms: pneumonia, bronchitis, lung abscess, empyema; urinary tract infections; infections of skin and soft tissue; intra-abdominal infections; gynecological infections; septicemia; febrile neutropenia; bacterial meningitis in children; prevention of infections in abdominal surgery
StagePhase III CT
Year completedpresent
Product TypeFDC - Cefepime + Sulbactam
IndicationAs monotherapy or in combination with other antiretroviral agents for the treatment of infections caused by human immunodeficiency virus-1 (HIV-1)
StageBE/PK
Year completedpresent
Product TypeFDC - Efavirenz + Emtricitabine + Tenofovir
IndicationChronic hepatitis in adults
StageBE/PK
Year completedpresent
Product TypeINN - Entecavir
IndicationAs monotherapy or in combination with other antiretroviral agents for the treatment of infections caused by human immunodeficiency virus-1 (HIV-1)
StageBE/PK
Year completedpresent
Product TypeFDC - Efavirenz + Emtricitabine + Tenofovir
IndicationHIV infection in adults and children older than 3 years in combination therapy
StageBE/PK
Year completedpresent
Product TypeINN - Ritonavir
IndicationChronic hepatitis in adults
StageBE/PK
Year completedpresent
Product TypeINN - Entecavir
IndicationHIV/AIDS
StageBE/PK
Year completedpresent
Product TypeINN - Efavirenz
IndicationHIV/AIDS
StageBE/PK
Year completedpresent
Product TypeFDC - Lamivudine + Zidovudine
IndicationHIV/AIDS
StageBE/PK
Year completedpresent
Product TypeINN - Lamivudine
IndicationCMV retinitis in adults with AIDS, prevention of CMV infection after transplantation of solid organs
StageMA
Year completed2016
Product TypeINN - Valganciclovir
IndicationInfectious-inflammatory diseases caused by microorganisms sensitive to the drug
StageMA
Year completed2016
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationInfectious-inflammatory diseases caused by microorganisms sensitive to the drug
StageMA
Year completed2016
Product TypeINN - Levofloxacin
IndicationHIV-1 infection
StageMA
Year completed2016
Product TypeFDC - Tenofovir + Emtricitabine
IndicationInfections of skin and mucous membranes caused by HSV (herpes genitalis), labially herpes (herpes labialis); prevention of infections caused by cytomegalovirus (CMV), and diseases after transplantation of parenchymal organs, shingles (herpes zoster) and ophthalmic zoster virus
StageMA
Year completed2016
Product TypeINN - Valganciclovir
IndicationInfectious-inflammatory diseases caused by microorganisms sensitive to moxifloxacin
StageMA
Year completed2016
Product TypeINN - Moxifloxacin
IndicationInfectious-inflammatory diseases, caused by susceptible to linezolid aerobic and anaerobic gram-positive microorganisms: community-acquired pneumonia caused by Streptococcus pneumoniae; hospital-acquired pneumonia; complicated infections of skin and soft tissues; uncomplicated skin infections and soft tissue infections caused by resistant to vancomycin Enterococcus faecium, accompanied by bacteremia as well
StageMA
Year completed2015
Product TypeINN - Linezolid
IndicationInfection caused by the virus Varicella Zoster and Herpes simplex type I and II
StageMA
Year completed2015
Product TypeINN - Famciclovir
IndicationСorneal ulcers and infections of the anterior segment of the eyeball and its adnexa caused by susceptible to ciprofloxacin bacteria in adults, newborns, babies and infants, children and adolescents
StageMA
Year completed2015
Product TypeINN - Ciprofloxacin
IndicationHIV 1 infection in adults in combination therapy with other antiretroviral drugs
StageMA
Year completed2015
Product TypeINN - Nevirapine
IndicationCMV (cytomegalovirus) retinitis in AIDS patients; prevention of CMV infection after transplantation of solid organs in patients from high risk groups
StageBE/PK
Year completed2015
Product TypeINN - Valganciclovir
IndicationHIV-1 and HIV-2 infections in adults in the complex therapy with other antiretroviral drugs
StageBE/PK
Year completed2015
Product TypeFDC - Tenofovir + Emtricitabine
IndicationInfections of upper and lower respiratory tract; infections of the urinary tract and kidneys; chronic bacterial prostatitis; infections of skin and soft tissue; intra-abdominal infections; tuberculosis (complex therapy of drug-resistant forms)
StageBE/PK
Year completed2015
Product TypeINN - Levofloxacin
IndicationInfectious-inflammatory diseases, caused by susceptible to linezolid aerobic and anaerobic gram-positive microorganisms: community-acquired pneumonia caused by Streptococcus pneumoniae; hospital-acquired pneumonia; complicated infections of skin and soft tissues; uncomplicated skin infections and soft tissue infections caused by resistant to vancomycin Enterococcus faecium, accompanied by bacteremia as well
StageBE/PK
Year completed2015
Product TypeINN - Linezolid
IndicationBacterial infections of upper and lower respiratory tract, urinary tract, skin and soft tissues, bones and joints, others
StageBE/PK
Year completed2015
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationHIV/AIDS
StageBE/PK
Year completed2015
Product TypeFDC - Abacavir + Lamivudine
IndicationHIV/AIDS
StageBE/PK
Year completed2015
Product TypeINN - Abacavir
IndicationHIV/AIDS
StageMA
Year completed2015
Product TypeINN - Stavudine
IndicationHIV/AIDS
StageBE/PK
Year completed2015
Product TypeFDC - Abacavir + Lamivudine
IndicationHerpes Zoster, infection and prevention of recurrent infections of skin and mucous membranes caused by herpes simplex; prevention of transmission of genital herpes uninfected partner; prevention of cytomegaloviruses infection, and reactions of acute transplant rejection, opportunistic infections and other (herpes simplex, Herpes Zoster) infections after organ transplantation
StageBE/PK
Year completed2015
Product TypeINN - Valaciclovir
IndicationBacterial infections of upper and lower respiratory tract, urinary tract, female genital organs, skin and soft tissues, bones and joints, others; prevention of postoperative infections in surgical interventions
StageMA
Year completed2015
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationInfectious-inflammatory diseases caused by sensitive to moxifloxacin microorganisms: acute sinusitis; exacerbation of chronic bronchitis; community-acquired pneumonia; infections of skin and soft tissues; complicated intraabdominal infections
StageMA
Year completed2015
Product TypeINN - Moxifloxacin
IndicationHIV/AIDS
StageMA
Year completed2015
Product TypeINN - Efavirenz
IndicationBacterial infections caused by pathogens susceptible to the FDC: infections of upper and lower respiratory tract; urinary tract infections, infections of the female genital organs, gonorrhea; infections of skin and soft tissues; infections of bones and joints; septic abortion, puerperal sepsis, septicaemia, peritonitis, intraabdominal sepsis, postoperative infection
StageMA
Year completed2015
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationInfection caused by the virus Varicella Zoster and Herpes simplex type I and II
StageBE/PK
Year completed2014
Product TypeINN - Famciclovir
IndicationHIV/AIDS
StageBE/PK
Year completed2014
Product TypeINN - Efavirenz
IndicationHIV/AIDS
StageMA
Year completed2014
Product TypeINN - Efavirenz
IndicationHIV/AIDS
StageMA
Year completed2014
Product TypeFDC - Lamivudine + Zidovudine
IndicationHIV/AIDS
StageMA
Year completed2014
Product TypeINN - Darunavir
IndicationHIV/AIDS
StageBE/PK
Year completed2014
Product TypeINN - Abacavir
IndicationEndocarditis, septicemia, infections of bones and joints, infections of the lower respiratory tract, infections of skin and soft tissues, urinary tract infections, peritonitis, prevention of infectious complications in dental and orthopedic operations
StagePhase III CT
Year completed2014
Product TypeINN - Teicoplanin (glycopeptide)
IndicationHIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Efavirenz
IndicationHIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Darunavir
IndicationHIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Zidovudine + Lamivudine
IndicationHIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Lamivudine
IndicationTuberculosis, extrapulmonary tuberculosis, atypical mycobacterial infections
StageBE/PK
Year completed2013
Product TypeINN - Cycloserine
IndicationHIV/AIDS
StageMA
Year completed2013
Product TypeINN - Lamivudine
IndicationInfections of ENT organs, infections of the lower respiratory tract, infections of the urinary tract and kidneys, chronic bacterial prostatitis, infections of skin and soft tissues , intra-abdominal infections
StageBE/PK
Year completed2013
Product TypeINN - Levofloxacin
IndicationChronic hepatitis B, HIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Lamivudine
IndicationChronic hepatitis B, HIV/AIDS
StageBE/PK
Year completed2013
Product TypeINN - Lamivudine
IndicationInfections of the lower respiratory tract, urinary tract infections, intraabdominal infections, infections of skin and soft tissues, septicemia, gynecologic infections, bacterial infections in patients with neutropenia, infections of bones and joints
StageMA
Year completed2012
Product TypeFDC - Piperacillin + Tazobactam
IndicationInfections of upper and lower respiratory tract infections, infections of skin and soft tissues
StageMA
Year completed2012
Product TypeINN - Clarithromycin
IndicationCommunity-acquired pneumonia; complicated infections of skin and soft tissue, complicated intraabdominal infections
StageMA
Year completed2012
Product TypeINN - Moxifloxacin
IndicationInfections of the lower respiratory tract, urinary tract infections, intraabdominal infections, infections of skin and soft tissues, septicemia, gynecologic infections, bacterial infections in patients with neutropenia, infections of bones and joints
StageMA
Year completed2012
Product TypeFDC - Piperacillin + Tazobactam
IndicationInfections of lower respiratory tract, infections of urinary system, infections of skin and soft tissue, infection of pelvic organs, bacterial meningitis
StageMA
Year completed2011
Product TypeINN - Meropenem
IndicationBacterial infections of upper and lower respiratory tract, urinary tract, female genital organs, skin and soft tissues, bones and joints, others; prevention of postoperative infections in surgical interventions
StageMA
Year completed2011
Product TypeFDC - Amoxicillin + Clavulanic acid
IndicationAmebiasis, bacterial infection
StageMA
Year completed2011
Product TypeINN - Ornidazole

Inflammatory

Indication
Stage
Year completed
Product Type
IndicationInfectious-inflammatory diseases caused by sensitive to imipenem microorganisms
StageMA
Year completed2014
Product TypeFDC - Imipenem + Cilastatin
IndicationAcute pain in the postoperative period - appendectomy
StagePhase III CT
Year completed2014
Product TypeINN - Paracetamol
IndicationPain of moderate intensity in postoperative period and short-term relief of fever
StageMA
Year completed2012
Product TypeINN - Paracetamol
IndicationInflammatory and degenerative diseases of the musculoskeletal system
StageMA
Year completed2011
Product TypeINN - Diclofenac

Intensive care

Indication
Stage
Year completed
Product Type
IndicationMyorelaxation for performing the intubation and artificial lung ventilation, skeletal muscle relaxation during surgery and mechanical ventilation in intensive care units
StageMA
Year completed2014
Product TypeINN - Atracurium besilate

Metabolic diseases

Indication
Stage
Year completed
Product Type
IndicationHypercholesterolemia, hypertriglyceridemia
StageBE/PK
Year completedpresent
Product TypeINN - Rosuvastatin
IndicationSecondary hyperparathyroidism in patients with end-stage renal failure who are on dialysis; hypercalcemia in patients caused by carcinoma of the parathyroid glands, by primary hyperparathyroidism
StageBE/PK
Year completedpresent
Product TypeINN - Cinacalcet
IndicationSecondary hyperparathyroidism in patients with ESRD undergoing dialysis. hypercalcemia
StageMA
Year completed2016
Product TypeINN - Cinacalcet
IndicationIntense physical exertion and emotional stress; chronic gastritis and chronic pancreatitis, skin diseases, etc - in complex therapy
StagePreclinical
Year completed2013
Product TypeINN - Levocarnitine

Nephrology / Cardiovascular

Indication
Stage
Year completed
Product Type
IndicationEssential hypertension, nephropathy caused by arterial hypertension and diabetes mellitus type II
StageBE/PK
Year completedpresent
Product TypeINN - Irbesartan

Oncology

Indication
Stage
Year completed
Product Type
IndicationNon-Hodgkin's lymphoma
StageMA
Year completedpresent
Product TypeBiosimilar - Rituximab
IndicationMetastatic castrate-resistant prostate cancer
StageBE/PK
Year completedpresent
Product TypeINN - Abiraterone
IndicationСommon renal cell carcinoma
StageBE/PK
Year completedpresent
Product TypeINN - Pazopanib
IndicationMetastatic castration-resistant prostate cancer
StageBE/PK
Year completedpresent
Product TypeINN - Abiraterone
IndicationLocally advanced or metastatic non-small cell lung cancer
StageBE/PK
Year completedpresent
Product TypeINN - Gefitinib
IndicationGastrointestinal stromal tumors; common and/or metastatic renal cell carcinoma
StageBE/PK
Year completedpresent
Product TypeINN - Sunitinib
IndicationMultiple myeloma
StageBE/PK
Year completedpresent
Product TypeINN - Lenalidomide
IndicationChronic myeloid leukemia
StageBE/PK
Year completedpresent
Product TypeINN - Nilotinib
IndicationBreast cancer, colorectal cancer, stomach cancer
StageBE/PK
Year completedpresent
Product TypeINN - Capecitabine
IndicationСhronic myeloid leukemia (CML) in adults and children; acute lymphoblastic leukemia (ALL) in adults in combination with chemotherapy; recurrent or refractory Ph+ ALL in adults as monotherapy; myelodysplastic / myeloproliferative diseases associated with genetic rearrangements of the receptor of the platelet growth factor in adults; systemic mastocytosis in adults; hypereosinophilic syndrome and / or chronic eosinophilic leukemia in adults; unresectable and / or metastatic malignant gastrointestinal stromal tumors; unresectable, recurrent and / or metastatic dermatofibrosarcoma in adults
StageBE/PK
Year completedpresent
Product TypeINN - Imatinib
IndicationBreast cancer, lung cancer
StagePhase III CT
Year completedpresent
Product TypeINN - Docetaxel
IndicationNon-small cell lung cancer and pancreatic сancer
StageМА
Year completed2015
Product TypeINN - Erlotinib
IndicationNon-small cell lung cancer, pancreatic cancer
StageBE/PK
Year completed2015
Product TypeINN - Erlotinib
IndicationСhronic myeloid leukemia (CML) in adults and children; acute lymphoblastic leukemia (ALL) in adults in combination with chemotherapy; recurrent or refractory Ph+ ALL in adults as monotherapy; myelodysplastic / myeloproliferative diseases associated with genetic rearrangements of the receptor of the platelet growth factor in adults; systemic mastocytosis in adults; hypereosinophilic syndrome and / or chronic eosinophilic leukemia in adults; unresectable and / or metastatic malignant gastrointestinal stromal tumors; unresectable, recurrent and / or metastatic dermatofibrosarcoma in adults
StageMA
Year completed2014
Product TypeINN - Imatinib
IndicationBreast cancer, non-small cell lung cancer, ovarian cancer, prostate cancer, gastric cancer, head and neck cancer
StageMA
Year completed2014
Product TypeINN - Docetaxel
IndicationBreast cancer
StageMA
Year completed2012
Product TypeINN - Letrozole
IndicationBreast cancer
StageMA
Year completed2012
Product TypeINN - Anastrozole
IndicationBladder cancer, breast cancer, head and neck cancer, acute leukemia, NSCLC, non-Hodgkin's lymphoma, multiple myeloma, ovarian cancer, pancreatic cancer, prostate cancer, rectal cancer, others
StageMA
Year completed2011
Product TypeINN - Epirubicin
IndicationLung cancer, arterially cancer, ovarian cancer, pancreatic cancer, cervical cancer, breast cancer
StageMA
Year completed2010
Product TypeINN - Gemcitabine
IndicationGlioma, glioblastoma, common metastatic malignant melanoma
StageMA
Year completed2010
Product TypeINN - Temozolomide

Ophthalmology

Indication
Stage
Year completed
Product Type
IndicationReduction of elevated intraocular pressure in patients with ocular hypertension and open-angle glaucoma, aphakic glaucoma, secondary glaucomas
StageMA
Year completedpresent
Product TypeINN - Timolol
IndicationPrimary open-angle glaucoma
StagePhase III CT
Year completedpresent
Product TypeINN - Latanoprost
IndicationPrimary open-angle glaucoma
StagePhase III CT
Year completedpresent
Product TypeINN - Travoprost
IndicationAcute bacterial conjunctivitis
StagePhase III CT
Year completedpresent
Product TypeINN - Moxifloxacine hydrochloride
IndicationInfections of the eye and its appendages: blepharitis; conjunctivitis; keratoconjunctivitis; blepharoconjunctivitis; keratitis; iridocyclitis; prevention of postoperative infections
StagePhase III CT
Year completed2014
Product TypeINN - Tobramycin

Parasitic diseases

Indication
Stage
Year completed
Product Type
IndicationNematodosis, mixed helminthic infestations, strongyloidiasis, neurocysticercosis, echinococcosis of liver, lungs, and peritoneum, giardiasis, toxocariasis
StageBE/PK
Year completedpresent
Product TypeINN - Albendazole

Pediatrics

Indication
Stage
Year completed
Product Type
IndicationFunctional bowel disorders, accompanied by abdominal pain with intestinal colic and flatulence (gastroenterology)
StageMA
Year completed2011
Product TypeHomeopathic

Respiratory

Indication
Stage
Year completed
Product Type
IndicationAsthma
StagePhase II CT
Year completedpresent
Product TypeBranded pharmaceutical

Respiratory / Infectious diseases

Indication
Stage
Year completed
Product Type
IndicationAcute and chronic bronchitis, tracheitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchial asthma, bronhoektatical disease, cystic fibrosis and other lung diseases accompanied by bronchospasm, mucus plugging of the bronchial tree, heavy mucus discharge
StageBE/PK
Year completedpresent
Product TypeFDC - Ambroxol + Salbutamol + Guaifenesin
IndicationPulmonary tuberculosis, extrapulmonary tuberculosis, atypical mycobacterial infection including those caused by Mycobacterium avium; acute urinary tract infections caused by susceptible strains of gram-positive and gram-negative bacteria, especially Klebsiella spp. Enterobacter spp and Escherichia coli
StageBE/PK
Year completedpresent
Product TypeINN - Cycloserine
IndicationNosocomial pneumonia caused metitsillinrezistentnye strains of Staphylococcus aureus
StagePhase III MMCT
Year completedpresent
Product TypeINN - Linezolid
IndicationNosocomial pneumonia
StagePhase III CT
Year completedpresent
Product TypeINN - Linezolid
IndicationDrug-resistant forms of tuberculosis
StageMA
Year completed2016
Product TypeINN - Terizidone
IndicationDrug-resistant forms of tuberculosis
StageMA
Year completed2016
Product TypeINN - Terizidone
IndicationDrug-resistant tuberculosis of various forms and localization
StageMA
Year completed2015
Product TypeFDC - Terizidone + Pyridoxine
IndicationDrug-resistant tuberculosis of various forms and localization
StageBE/PK
Year completed2015
Product TypeINN - Aminosalicylic acid
IndicationDrug-resistant tuberculosis of various forms and localization
StageBE/PK
Year completed2015
Product TypeINN - Terizidone
IndicationInfectious-inflammatory diseases caused by sensitive to levofloxacin by micro-organisms: lower respiratory tract infection; acute maxillary sinusitis; uncomplicated urinary tract infections; complicated urinary tract infections; infections of skin and soft tissue; septicemia / bacteremia; chronic bacterial prostatitis; intra-abdominal infection; complex therapy of drug-resistant forms of tuberculosis
StageMA
Year completed2014
Product TypeINN - Levofloxacin
IndicationTuberculosis of different forms and locations (in combination with other anti-TB drugs), including multidrug-resistance to other anti-TB drugs
StageMA
Year completed2014
Product TypeINN - Aminosalicylic acid
IndicationDrug-resistant tuberculosis of various forms and localization
StageBE/PK
Year completed2014
Product TypeFDC - Terizidone + Pyridoxine
IndicationTuberculosis
StageBE/PK
Year completed2013
Product TypeFDC - Cycloserine + Pyridoxine
IndicationDrug-resistant tuberculosis of various forms and localization
StageMA
Year completed2013
Product TypeINN - Aminosalicylic acid
IndicationDrug-resistant tuberculosis of various forms and localization
StageMA
Year completed2013
Product TypeINN - Terizidone
IndicationDrug-resistant tuberculosis of various forms and localization
StageMA
Year completed2012
Product TypeINN - Terizidone
IndicationTuberculosis of various localizations
StageMA
Year completed2012
Product TypeFDC - Isoniazid + Pyrazinamide + Rifampicin
IndicationColds, flu, acute respiratory viral diseases
StageMA
Year completed2012
Product TypeFDC - Caffeine + Paracetamol + Phenylephrine + Chlorphenamine
IndicationTuberculosis
StageBE/PK
Year completed2012
Product TypeINN – Terizidone
IndicationTuberculosis
StageBE/PK
Year completed2012
Product TypeINN - Terizidone
IndicationTuberculosis of various forms and localizations
StageMA
Year completed2011
Product TypeINN - Aminosalicylic acid
IndicationAcute respiratory diseases
StageMA
Year completed2011
Product TypeBotanical drug - Anti-cold drug
IndicationPulmonary tuberculosis
StageMA
Year completed2011
Product TypeINN - Capreomycin
IndicationTuberculosis, atypical mycobacterial infection, urinary tract infection
StageMA
Year completed2011
Product TypeINN - Cycloserine
IndicationLower respiratory tract infections, acute bacterial sinusitis, others
StageMA
Year completed2010
Product TypeINN - Levofloxacin

Rheumatology

Indication
Stage
Year completed
Product Type
IndicationOsteoarthritis, rheumatoid arthritis, ankylosing spondylitis, back pain, musculoskeletal, postoperative and other types of pain, primary dysmenorrhea
StageBE/PK
Year completedpresent
Product TypeINN - Celecoxib
IndicationOsteoarthritis, rheumatoid arthritis and ankylosing spondylitis, pain syndrom, primary dysmenorrhea
StageBE/PK
Year completed2015
Product TypeINN - Celecoxib
IndicationRheumatoid arthritis, osteoarthritis, arthritis of various etiologies, arthralgia, myalgia, postoperative and posttraumatic pain, bursitis, tendonitis, dysmenorrhoea, dental and headache
StageMA
Year completed2013
Product TypeINN - Nimesulide
IndicationOsteoarthritis of I-III stages of peripheral joints and spine.
StageMA
Year completed2012
Product TypeFDC - Glucosamine sulphate + Chondroitin sulfate Potassium Adipate + Vitamin E

Transplantology

Indication
Stage
Year completed
Product Type
IndicationRejection of the allograft liver, kidney and heart
StageMA
Year completed2012
Product TypeINN - Tacrolimus
IndicationAcute rejection of allogeneic transplant kidney
StageMA
Year completed2012
Product TypeINN - Mycophenolate mofetil

Urology

Indication
Stage
Year completed
Product Type
IndicationOveractive bladder syndrome
StageBE/PK
Year completedpresent
Product TypeINN - Solifenacin