- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Glenmark Pharma gets USFDA nod for two generic drugs
New Delhi: Glenmark Pharma said it has received final approval from the USFDA to manufacture and market Potassium Chloride extended release capsules and oral contraceptive Norethindrone Acetate and Ethinyl Estradiol tablets in the American market.
"Glenmark Pharmaceuticals Inc has been granted final approval by the US Food and Drug Administration (US FDA) for Potassium Chloride extended release capsules USP, 10mEq, of Actavis Laboratories FL, Inc," the company said in a BSE filing.
Quoting IMS data, Glenmark Pharma said the approved product has an estimated market size of $74.1 million for the 12 months ended November 2015.
The company has also received approval for Norethindrone Acetate and Ethinyl Estradiol tablets.
It is a generic version of US-based Warner Chilcott's oral contraceptive drug 'Leostrin21'
"The approved product has an estimated market size of $ 56.8 million for the 12 months ending November 2015, according to IMS," Glenmark Pharma added.
Glenmark Pharma's current portfolio consists of 62 ANDAs pending approvals from the US FDA and 106 products authorised for distribution in the US.
"Glenmark Pharmaceuticals Inc has been granted final approval by the US Food and Drug Administration (US FDA) for Potassium Chloride extended release capsules USP, 10mEq, of Actavis Laboratories FL, Inc," the company said in a BSE filing.
Quoting IMS data, Glenmark Pharma said the approved product has an estimated market size of $74.1 million for the 12 months ended November 2015.
The company has also received approval for Norethindrone Acetate and Ethinyl Estradiol tablets.
It is a generic version of US-based Warner Chilcott's oral contraceptive drug 'Leostrin21'
"The approved product has an estimated market size of $ 56.8 million for the 12 months ending November 2015, according to IMS," Glenmark Pharma added.
Glenmark Pharma's current portfolio consists of 62 ANDAs pending approvals from the US FDA and 106 products authorised for distribution in the US.
Next Story