• Facilities Overview
• R&D
• Manufacturing
• Quality Assurance and Control
• Regulatory Affairs
• Regulatory Status
• Environment, Health and Safety (EHS)
• IT Infrastructure

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.

Neuland’s manufacturing facilities at Bonthapalli and Pashamylaram have been inspected by the US FDA and also hold GMP approval from several regulatory authorities. Neuland’s Pashamylaram facility received GMP certificate from German Health authority in June 2007 and the Bonthapally facility has been successfully audited by PMDA (Japan) in October 2008.

Neuland with 33 USDMFs, 15 Canadian DMFs, 9 DMFs in Australia, 3 DMFs in Japan and 363 DMFs in various European and other regulatory markets has an unrelenting commitment and continues to be a preferred source worldwide. Neuland is accredited with CoS from EDQM for 13 of its APIs across five therapeutic categories.

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