Category: USFDA Approvals
Astral Pharma which manufactures sterile antibiotic powder injectables at Makrarpura in Vadodara in Gujarat has received USFDA approval, which facilitates the company to market its product in USA. The company has already received approvals from HPFBI-Canada, TGA-Australia, MCC-South Africa and ANVISA-Brazil. It has entered into strategic business tie up with Sagent Pharmaceutical Inc with whom more than 15 Abbreviated New Drug Application (ANDAs) have been filled for US market. At Makarpura, the company has two manufacturing facilities- one for Semi Synthetic Penicillin group and other for cephlasporin group.