Gen Pharmaceuticals

Gen Pharmaceuticals

Turkey - Ankara
Pharmaceutical
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Focus: Small Molecules

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CardiovascularNeurologyMusculoskeletalImmunologyMetabolic Diseases
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Products & Portfolio (35)

15 discontinued products not shown

ACETIC ACID
acetic acid
Post-LOE
OTIC · SOLUTION/DROPS
CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.
2005
30
AMPHOTERICIN B
amphotericin b
Post-LOE
INJECTION · INJECTABLE
CLINICAL PHARMACOLOGY Microbiology Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum , Coccidioides immitis , Candida species, Blastomyces dermatitidis , Rhodotorula, Cryptococcus neoformans , Sporothrix schenckii , Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro . While Candida albicans is generally quite susceptible to amphotericin B, non- albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses. Susceptibility Testing Standardized techniques for susceptibility testing for antifungal agents have not been established and results of susceptibility studies have not been correlated with clinical outcomes. Pharmacokinetics Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols in the cell membrane of susceptible fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Mammalian cell membranes also contain sterols and it has been suggested that the damage to human cells and fungal cells may share common mechanisms. An initial intravenous infusion of 1 to 5 mg of amphotericin B per day, gradually increased to 0.4 to 0.6 mg/kg daily, produces peak plasma concentrations ranging from approximately 0.5 to 2 mcg/mL. Following a rapid initial fall, plasma concentrations plateau at about 0.5 mcg/mL. An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. Amphotericin B circulating in plasma is highly bound (>90%) to plasma proteins and is poorly dialyzable. Approximately two thirds of concurrent plasma concentrations have been detected in fluids from inflamed pleura, peritoneum, synovium, and aqueous humor. Concentrations in the cerebrospinal fluid seldom exceed 2.5% of those in the plasma. Little amphotericin B penetrates into vitreous humor or normal amniotic fluid. Complete details of tissue distribution are not known. Amphotericin B is excreted very slowly (over weeks to months) by the kidneys with 2 to 5% of a given dose being excreted in the biologically active form. Details of possible metabolic pathways are not known. After treatment is discontinued, the drug can be detected in the urine for at least 7 weeks due to the slow disappearance of the drug. The cumulative urinary output over a 7 day period amounts to approximately 40% of the amount of drug infused.
1992
30
ARIPIPRAZOLE
aripiprazole orally disintegrating
Post-LOE
ORAL · TABLET, ORALLY DISINTEGRATING
mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
Schizophrenia
2018
30
ATORVASTATIN CALCIUM
atorvastatin calcium
Post-LOE
ORAL · TABLET
selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles.
homozygous familial hypercholesterolemia (HoFH) ()hypertension
2016
30
BUPRENORPHINE
buprenorphine
Post-LOE
TRANSDERMAL · FILM, EXTENDED RELEASE
Partial Opioid Agonists
severepersistent painfor which alternative treatment options are inadequate
2021
30
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine and naloxone
Post-LOE
BUCCAL, SUBLINGUAL · FILM
naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
opioid dependence
2022
30
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
Post-LOE
ORAL · TABLET, EXTENDED RELEASE
extended-release tablets, (SR) enhances the ability of patients to abstain from smoking is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
2016
30
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
Post-LOE
ORAL · TABLET, EXTENDED RELEASE
unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the re-uptake of serotonin.
major depressive disorder (MDD)defined by the DiagnosticStatistical Manual (DSM)+1 more
2017
30
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
Post-LOE
ORAL · TABLET, EXTENDED RELEASE
known, but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
major depressive disorder (MDD)defined by the DiagnosticStatistical Manual (DSM)
2016
30
CALCIUM GLUCONATE
calcium gluconate
Post-LOE
INTRAVENOUS · SOLUTION
level. Calcium gluconate dissociates into ionized calcium in plasma. Ionized calcium and gluconate are normal constituents of body fluids.
2022
30
CARISOPRODOL
carisoprodol
Post-LOE
ORAL · TABLET
identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.
2014
30
CLONIDINE HYDROCHLORIDE
clonidine
Post-LOE
INJECTION · INJECTABLE
Mechanism of Action Epidurally administered clonidine produces dose-dependent analgesia not antagonized by opiate antagonists. The analgesia is limited to the body regions innervated by the spinal segments where analgesic concentrations of clonidine are present. Clonidine is thought to produce analgesia at presynaptic and postjunctional alpha-2-adrenoceptors in the spinal cord by preventing pain signal transmission to the brain.
combination with opiates for the treatment of severe pain in cancer patients
2013
30
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Interview Prep Quick Facts
Portfolio: 103 approved products
Top TAs: Cardiovascular, Neurology, Musculoskeletal
Portfolio Health
Post-LOE103 (100%)
103 total products
Therapeutic Area Focus
Cardiovascular
15 marketed
Neurology
12 marketed
Musculoskeletal
5 marketed
Immunology
3 marketed
Oncology
3 marketed
Marketed
Pipeline