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 Home » Neuland Quality » Regulatory affairs
             Quality Assurance | Quality Control
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Neuland is committed to the manufacture of  quality products in compliance with regulatory requirements and customer expectations. All our operations are in accordance with cGMP requirements, USFDA and ICH guidelines and regulations.

Neulands manufacturing facilities at Bonthapalli and Pashamylaram have been inspected by the USFDA and also boast GMP approval from TGA, Australia.  Neuland is accredited with COS from EDQM for eight of  its APIs across five therapeutic categories.  We support our customers with Drug Master Files for their dosage form applications / ANDA filings.

Neuland with 25 US DMFs and 276 DMF filings with various Health Authorities of Europe and other regulatory markets is testimony enough to Neuland’s unrelenting commitment and continuing to be a preferred source world wide.

"Neuland's Pashamylaram facility received GMP certificate from German Health authority in June 2007.              

Click Here for DMF Registrations
 
 
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