USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plant
The US health regulator has pulled up Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based active pharmaceutical ingredients (APIs) plant. In a warning letter issued to the company’s Managing…
Aurobindo Pharma’s API unit in Telangana gets VAI status from USFDA
Aurobindo Pharma on Tuesday, January 28, said the United States Food and Drug Administration (USFDA) has issued an establishment inspection report (EIR) to its subsidiary’s active pharmaceutical ingredient (API) facility in…
Aurobindo Pharma shares jump 2% after UK arm secures regulatory approval for cancer drug
Aurobindo Pharma shares jumped 2% to an intraday high of Rs 1,265 on the BSE after its wholly owned step-down subsidiary CuraTeQ Biologics received approval from the UK‘s Medicines and Healthcare products Regulatory Agency…
Glenmark Pharma gets USFDA nod for Acetaminophen and Ibuprofen tablets
New Delhi: Glenmark Pharmaceuticals Ltd has received final approval from the United States Food Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets, 250 mg/125 mg (OTC). The regulatory authority has…
With over 4,000 manufacturing units, Gujarat flag bearer of India’s pharma industry: State govt
Gujarat has been the flag bearer of India‘s pharma industry and a hub for pharmaceutical manufacturing and exports for years, the state government has said as it gears up to host the…
World’s 1st vaccine against chikungunya primed for launch in India, says French drugmaker Valneva
New Delhi: French biotech company Valneva, whose vaccine against mosquito-borne illness chikungunya received approval from the US Food and Drug. Administration (USFDA) last week — becoming the first licensed vaccine against…
Indian pharma industry headwinds in remission: ICRA
New Delhi: ICRA expects the revenues of the sample set of 25 Indian pharmaceutical companies (which account for ~60 per cent of the overall Indian pharmaceutical industry) to grow by 7-9 per…
Granules approval for ADHD drug
Granules India said that its wholly owned foreign subsidiary, Granules Pharmaceuticals has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Amphetamine Mixed…
USFDA approves this oral heart disease drug
Bristol Myers Squibb said on Thursday the U.S. Food and Drug Administration (USFDA) approved its oral heart disease drug Mavacamten, making it the first cardiac myosin inhibitor to be permitted for use in the…
USFDA inspections back in full swing for Pharma Companies
USFDA plant inspections seem to be coming back strongly after a two-year hiatus, going by the just-concluded inspection at Zydus Lifesciences on March 10 and a warning letter to Aurobindo earlier…
