USFDA

Drug firm Alembic Pharmaceuticals today said it has received establishment inspection report (EIR) from the US health regulator for its Karakhadi facility in Gujarat. The company has received EIR from the United States Food and Drug Administration (USFDA) for the inspection carried out at the active pharmaceutical ingredient facility at Karakhadi from May 14-18, 2018, ...

Drug firm Zydus Cadila Tuesday said it has received final approval from the US health regulator to market Clindamycin Phosphate Topical Solution, used to treat acne. The company has received approval from the US Food and Drug Administration (USFDA) to market Clindamycin Phosphate Topical Solution USP (Cleocin T), 1 per cent, Zydus Cadila said in ...

Drug firm Zydus Cadila today said it has got tentative nod from the US health regulator to market Deferasirox tablets for oral suspension. "Zydus Cadila has received the tentative approval from USFDA to market Deferasirox Tablets for Oral Suspension (Exjade Tablets) in the strengths of 125 mg, 250 mg and 500 mg," the company said ...

Glenmark Pharma today said its subsidiary Glenmark Specialty has entered into an exclusive licensing agreement with Australia's Seqirus to commercialise its nasal spray Ryaltris in Australia and New Zealand. Ryaltris is indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age. "Under the terms of the agreement, ...

With about 7,000 Indian women participating in a World Health Organisation led study on heat-stable Carbetocin, the injectible drug is now set for registration with the Indian drug regulator for approvals to sell locally, said Suresh Pattathil, Chief Executive of Ferring Pharmaceuticals. Used to prevent excessive bleeding at birth, heat-stable Carbetocin is an alternative to ...