Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
It ensures sufficient serum estradiol levels to alleviate menopausal symptoms
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency
According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million
The company will submit an action plan on the observations and will engage with US FDA for next steps.
The current ruling will assure the safety of the use of Ranitidine for Indian patients
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
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