Alembic Pharmaceuticals completed a USFDA cGMP inspection at its Karakhadi Injectable Facility (F-3) from February 9–18, 2026. The inspection ended with two observations, none related to data ...

The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.

The US Food and Drug Administration (USFDA) conducted an inspection of the company's Digwal (Telangana ) based plant from ...

At current levels, the stock is trading about 6.8 percent below its 52-week high and nearly 19.79 percent above its 52-week ...

At the conclusion of the inspection, the USFDA issued a Form 483 with 6 procedural observations. Enzene has achieved Zero observations related to data integrity - a critical validation of Enzene's ...

New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures. The company has received approval from the US ...

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug ...

PRVs are tradable vouchers issued by the USFDA to incentivize development of treatments for rare pediatric conditions, and can be redeemed to secure a priority review for a separate, future drug ...

Alkem Laboratories on Monday said the US health regulator has issued a Form 483 with six observations after inspecting the Chakan-based manufacturing unit of its wholly-owned subsidiary.

NEW DELHI: Drug firm Morepen Laboratories on Friday said it has received approval from the US health regulator to market its anti-allergy drug Fexofinadine Hydrochloride in the American market. The ...

Shares of Wockhardt Ltd soared 20 per cent in Monday's trade to hit a high of Rs 1,480.25 after the pharma company announced that the United States Food and Drug Administration (USFDA) has formally ...

Cipla Ltd on Saturday said that the company has received eight observations from United States Food and Drug Administration (USFDA) after it conducted a current Good Manufacturing Practices (cGMP) ...