US FDA

The facility had received six observations in Form 483s and was classified as ‘OAI’ (Official Action Indicated’) in March 2019

"Looking ahead, FY2020 is an exciting year for Lupin as we plan to bring our first biosimilar to market and commercialise our…

The company has been issued a Form 483 Dr Reddy's Laboratories said the US health regulator has issued five observations after…

The inspection was carried out from July 8 to 12 July 2019 Laurus Labs, a leading research and development-driven and…

Dr Reddy's Laboratories has said the company plans to launch several value-added products this fiscal to offset the persisting…

Lupin’s Phenylephrine and Ketorolac Intraocular Solution, 1 per cent 0.3 per cent is the generic version of Omidria Intraocular…

The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator

Carboprost Tromethamine is used to treat severe bleeding after childbirth (postpartum) and is also used to produce an abortion by…

The approved product is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals

Dr Reddy’s Tobramycin Inhalation Solution, USP is available in a 300 mg/5 mL, single-dose Ampule