USFDA successfully concludes audit at FDC Baddi facility
Mumbai: Through a recent BSE filing, FDC Limited has informed that U.S. Food and Drug Administration (US FDA) has successfully completed an audit with "No observations" (Zero 483's) at the Company's manufacturing facility located at Baddi, Himachal Pradesh.
This facility is dedicated to manufacturing Cephalosporins and its combination products. It has the capacity to manufacture Solid and Liquid dosage forms of Cephalosporins.
This facility houses a State-of-the-Art Pilot Plant for the manufacture of exhibit batches for Regulated Markets. This facility is approved by US-FDA and WHO-GMP. Currently caters to the needs of the Indian market.
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Founded in 1936, FDC Limited is the pharmaceutical company headquartered in India. FDC has manufacturing units in Baddi, Goa, Roha, Waluj and Sinnar that have the capability of creating APIs and finished dosage forms. These manufacturing units have been certified by top international institutions such as US-FDA, UK-MHRA, WHO-GMP, BIS; ISO 22000: 2018 Food Safety Management System, HACCP and other regulatory bodies.
Read also: FDC Roha facility successfully concludes USFDA audit
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