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BIOEQUIVALENCE CENTER
Gland Pharma shares rise 5% on receiving US FDA approval for vitamin K deficiency injectableGland Pharma shares rose after receiving FDA approval for phytonadione injectable emulsion, a product used for coagulation disorders. Despi...- Smallcap pharma stock jumps over 11% as arm receives tentative USFDA approval for HIV drug DolutegravirThe company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the USFDA, of whic...
- TAKE Solutions enters partnership with H.I.G. Capital to accelerate growth of Navitas Life SciencesThrough this strategic alliance, an affiliate of H.I.G. will be acquiring a 75% stake of Navitas Life Sciences, a wholly owned subsidiary o...
- Alkem Laboratories says USFDA inspection at Taloja facility ends with 'zero' observationsThe US Food and Drug Administration (USFDA) had conducted a remote and virtual bio-analytical inspection of the company's Bioequivalence Ce...
- Sun Pharma shuts two clinical pharmacology units in VadodaraAs per industry sources, the move would impact around 80 staffers at the two locations.
- Drug applications based on Semler's data unacceptable: USFDAThe letter informs the sponsor that it must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an accep...
- Mankind forays into OTC marketFormulation drug maker Mankind Pharma has ventured into Rs 2,000 crore over-the-counter (OTC) market and will launch seven products in the ...
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