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cGMP Expertise

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Agno Phama is a US-FDA approved CRO/CMO, with a US-FDA approved and inspected ISO 9001, ISO 14001, & OHSAS 18001 Certified GMP API Facility in China. We have developed a significant cGMP manufacturing track record, with Quality Systems that are essential to our business. Agno Pharma is committed to ensuring the highest quality and regulatory standards. The company facilities were audited and approved by more than 6 Major Pharma QA groups, along with a US-FDA inspection on November 2014. Prior to the start of a cGMP production campaign, our scientific staff will work closely with the client to develop a QA protocol, batch record generation, product specifications, and a timely delivery date. Our cGMP expertise originated from our team's experience in cGMP operations while employed by major US and European pharmaceutical companies, prior to joining Agno Pharma. Our USA cGMP laboratory has successfully passed 5 US-FDA cGMP inspections. The same cGMP quality system has been implemented to many of our JVs and partnering companies in China, which have been successfully inspected by US-FDA and EMA over the last six years.

Chemistry Process & Manufacturing
High Potency APIs
Analytical Development
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