Hikal receives USFDA approval for its pharmaceutical manufacturing site in Gujarat

26 Apr 2013 Evaluate

Hikal’s second manufacturing facility located at Panoli, Bharuch district in the state of Gujarat, which manufactures pharmaceutical ingredients, intermediates and regulated starting materials has successfully completed a USFDA audit and received the approval. The company has already received USFDA approval for its pharmaceutical intermediates and active pharma ingredients (API's) manufacturing site located in Jigani, Bengaluru in Karnataka state.

This additional site approval will further add to capacities, which is beneficial to its customers. It will mitigate the risk of supply by having two sites certified by the USFDA. The additional site certification is a true testimony to the high standards of quality, regulatory compliance and operating standards at Hikal.

Both the sites have multipurpose facilities and capabilities which support the company’s global customers. The pharmaceutical division is supported by 2 R&D centres based in Bangalore and Pune, India where they provide early stage research services, new product development all the way to successful commercialization. The API manufacturing site at Bangalore has been inspected 3 times by the USFDA.

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