FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical
FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA Issues Guidance on Identifying Suspect Drugs
FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

FDA Licenses First US Facility for Cell-Culture Influenza Vaccines
Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

Research Firm Predicts Negative Impact of Biosimilars
A new report from GlobalData states that biosimilars will overtake the market share after 2019.

FDA Releases Draft Guidance on ANDA Submissions
Draft guidance from FDA includes information essential for the completion of ANDA applications.

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EMA Publishes New Guidance for Qualified Person's Declaration on GMP Compliance of API
EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

ISPE Announces Quality Metrics Pilot Launch
ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.