Zydus gets EIR for injectables manufacturing facility at Zydus Biotech Park EP News Bureau Sep 13, 2023 The inspection had concluded with NIL observations
Viatris gets tentative nod from US FDA for Abacavir/Dolutegravir/Lamivudine to treat paediatric HIV… EP News Bureau Sep 5, 2023 Tentative approval will help enhance access to WHO-recommended paediatric regimen with the goal of improved adherence of HIV…
Zydus gets US FDA approval for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg EP News Bureau Aug 31, 2023 Isotretinoin Capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment
Ajanta gets US FDA approval for Topiramate ER Capsules EP News Bureau Aug 30, 2023 As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances
Strides gets USFDA approval for Mycophenolate Mofetil for Oral Suspension EP News Bureau Aug 30, 2023 The products will be manufactured at the company’s facility in Bengaluru
Mankind Pharma launches 120 DMF quality drugs for Indian patients EP News Bureau Aug 29, 2023 The Drug Master File (DMF) has all the information on an API (Active Pharmaceutical Ingredient/Raw material for medicine)
Lupin receives approval from USFDA for Pirfenidone tablets EP News Bureau Aug 25, 2023 This product will be manufactured at Lupin’s Pithampur facility in India
US FDA places partial clinical hold on Gilead’s studies on Magrolimab for AML treatment EP News Bureau Aug 22, 2023 The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk…
Lupin gets US FDA nod for Bromfenac Ophthalmic Solution, 0.09%; Metoprolol Succinate ER Tablets USP EP News Bureau Aug 16, 2023 Both products will be manufactured at Lupin’s Pithampur facility in India
Sigachi Industries forays into API business, acquires majority stake in Trimax Bio Sciences EP News Bureau Aug 11, 2023 The API unit is approved by USFDA for advanced and critical intermediates