Glenmark Pharma gets USFDA nod for two generic drugs
Advertisement
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.