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Regulatory Affairs

Neuland is committed to manufacturing products in total compliance with regulatory requirements and customer expectations. All process and manufacturing operations are in accordance with cGMP requirements, US FDA and ICH guidelines and regulations.

The manufacturing facilities at Bonthapally, Pashamylaram and Gaddapotharam have all been inspected by the USFDA and Units I and II also hold GMP approval from several regulatory authorities.

Neuland has now filed 56 DMFs with the USFDA, over 400 DMFs in Europe, and many more with the various health authorities in Canada, Japan, Korea and Australia.

The Company supports customers with complete documentation including Drug Master Files for their dosage form applications/ANDA filings.