The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The new production line is equipped with the latest advanced manufacturing system to produce quality products of Alkaloids & APIs used in a wide range of pharmaceutical applications
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
Ayush market has reached US $18 billion from meager US $3 billion under guidance and visionary leadership of our Prime Minister
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
The company will reduce wastage substantially, increase productivity, enhance environmental consciousness, save energy, optimally use natural resources, and expand its market penetration
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
Within the API segment, ~20% of the revenues came from the domestic market and ~80% from the exports market
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