Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
The Unit has been issued GMP Certification from ANVISA-Brazil
The Unit has been issued GMP Certification from ANVISA-Brazil
Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
Total value of the supplies of FC will be US$ 2.773 million
The clearance of this audit marks the successful registration of 8 APIs with CADIFA
Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management
Super-Bond is made up of a polymerization initiator, a liquid and a polymer powder
Brazil has the 4th largest pet market in the world with an estimated market size of BRL 1.8 billion, growing annually at 16%
Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
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