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Following an inspection of seven manufacturing facilities owned by its subsidiary Biocon Biologics, the US health regulator issued Form 483s with 11 observations for each of two sites in Bengaluru and six observations for a plant in Malaysia
Sun Pharmaceutical Laboratories filed an appeal against Hetero Healthcare alleging that its trade mark Letroz for second-line treatment of advanced breast cancer had been violated. The appeal was dismissed by a division bench of the Delhi High Court.
Speaking at the Himachal Drug Manufacturers Association, Union Minister of State said, “The state accounted for 35% of the country’s pharmaceutical production, with Baddi alone producing 20%. “
Under the production-linked incentive (PLI) scheme, Orchid Pharma will invest Rs 300- 500 crore over the following two years to establish a new plant to produce essential key starting materials or drug intermediaries.
Jai Ram Thakur, the chief minister, expressed gratitude to Prime Minister Narendra Modi and the federal government for granting the State access to the Bulk Drug Pharma Park.
USFDA has granted final approval to Zydus Lifesciences Limited to market two medications: Pregabalin extended-release tablets, USP 82.5 mg, 165 mg, and 330 mg; and Venlafaxine extended-release tablets, USP 37.5 mg, 75 mg, 150 mg, and 225 mg.
Biologics License Application for efanesoctocog
alfa (BIVV001), a rare and potentially fatal
bleeding disorder, has been accepted for priority
review by the US Food and Drug Administration
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