Granules India files Paragraph IV certification for Ruxolitinib Extended-Release Tablets
Company says it believes it is eligible for first-to-file status, subject to FDA review and determination
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ANDA
Zydus gets final US FDA approval for Ascorbic Acid Injection with 180-Days CGT exclusivity
The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for…
Zydus receives USFDA approval for generic Indocyanine Green for Injection
Dr Sharvil Patel says the approval expands Zydus’ portfolio of injectable and imaging products and supports its focus on…
Alembic Pharma announces partner NATCO Pharma gets USFDA tentative nod for Olaparib tablets
Alembic will distribute the product in the US, and its partner NATCO will manufacture Olaparib Tablets, 100 mg and 150 mg
Lupin gets US FDA nod for Famotidine Injection, USP
This product would be manufactured at Lupin’s Nagpur facility in India
Granules Pharmaceuticals receives FDA tentative approval for gDYANAVEL XR
Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received tentative approval (TA) from the US Food and…
Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic…
Company secures final ANDA approval with eligibility for 180 days of CGT exclusivity
Lupin gets tentative US FDA nod for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets
They are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least…
Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
The acquisition will be funded through the IPO proceeds raised by Senores. This is in line with the Objects of the IPO stated in…
Indoco Remedies gains final ANDA approval for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20…
Rivaroxaban Tablets USP will be manufactured at the company’s facility located in Goa