Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity
Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Indoco Remedies 'sBiologic Canagliflozin;Metformin Hydrocloride Receives Tentative Approval in US
Indoco Remedies Ltd., a fully integrated, research-oriented pharmaceutical company, announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for pregabalin capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg. This is a generic equivalent of the Reference Listed Drug, Lyrica capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg, of Upjohn US 2 LLC.
Indoco Remedies announced that the United States Food and Drug Administration (USFDA) successfully completed inspection of its API Kilo Lab manufacturing facility at Rabale, Navi Mumbai and Indoco Analytical Solutions (IAS) division. The inspection concluded with zero Form 483 observations.
Indoco Remedies Limited announced that the United States Food and Drug Administration (FDA) successfully completed inspection of its API Kilo Lab manufacturing facility at Rabale, Navi Mumbai and Indoco Analytical Solutions (IAS) division. The inspection concluded with zero Form 483 observations, reflecting the company's commitment to maintaining the highest standards of quality and compliance.
Indoco Remedies Limited has reported Consolidated financial results for the period ended September 30, 2023.
USFDA conducts pre-approval inspection at Indoco Remedies` Goa facility, issues `four observations`
Indoco Remedies gets EU-GMP certification for Himachal plant