USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including failing to establish laboratory controls and adequate testing programs.

The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.      In a warning letter, the ...

Pharma major Dr. Reddy's Laboratories reported a marginal 2% year-on-year (YoY) growth in its consolidated net profit at Rs 1 ...

Dr. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

Syngene's margins narrowed on a sequential basis. Apart from margins, Syngene's revenue and EBITDA are also lower by 14.1% ...

The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated’ (VAI) and has officially closed the ...

Zydus Lifesciences got USFDA approval for Celecoxib capsules (50–400 mg) to treat arthritis, JIA, and AS. Made in Ahmedabad, ...

A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...

Pharmaceutical major Dr. Reddys Laboratories reported its financial results for the first quarter (Q1) of FY26 on Thursday, ...

Biosimilars could make healthcare more affordable—but here’s why activists are pushing for major revisions and greater ...

Syngene International reported a 61% year-on-year increase in its Q1 profit after tax, reaching ₹87 crore. This growth was driven by revenue expansion and cost optimisation.

Dr. Reddy's Laboratories receives a Form 483 with seven observations from the USFDA after an inspection of its Srikakulam ...