Granules India gets USFDA nod for ibuprofen tablets
USFDA has given its nod to the drug maker Granules India to market generic Ibuprofen tablets -- used to treat fever, pain or inflammation -- in the American market. The Ibuprofen tablets in strengths of 400 mg, 600 mg, and 800 mg will now be made available by the Hyderabad-based company in the US."It's my pleasure to state that USFDA completed the review of Ibuprofen ANDA filed by us and...
Login or Register to read the full article
USFDA has given its nod to the drug maker Granules India to market generic Ibuprofen tablets -- used to treat fever, pain or inflammation -- in the American market. The Ibuprofen tablets in strengths of 400 mg, 600 mg, and 800 mg will now be made available by the Hyderabad-based company in the US.
"It's my pleasure to state that USFDA completed the review of Ibuprofen ANDA filed by us and has given its final approval," Granules India Chairman & Managing Director, C Krishna Prasad said in a statement.
The approval will further strengthen the company's base business and enable it to increase its product offering to customers in the US, he added.
Granules India produces finished dosages, pharmaceutical formulation intermediates and active pharmaceutical ingredients (APIs).
Granules global presence extends to over 300 customers in 60 countries through offices in India, US, UK, China and Colombia. It has the largest PFI facility in the world with an industry leading 6 ton batch size.
"It's my pleasure to state that USFDA completed the review of Ibuprofen ANDA filed by us and has given its final approval," Granules India Chairman & Managing Director, C Krishna Prasad said in a statement.
The approval will further strengthen the company's base business and enable it to increase its product offering to customers in the US, he added.
Granules India produces finished dosages, pharmaceutical formulation intermediates and active pharmaceutical ingredients (APIs).
Granules global presence extends to over 300 customers in 60 countries through offices in India, US, UK, China and Colombia. It has the largest PFI facility in the world with an industry leading 6 ton batch size.
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 site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd