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Jiangsu Hengrui Medicine Receives FDA Form 483 Following Inspection Discrepancies
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The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui Medicine (SHA: 600276), a leading drug manufacturer in China. The document, which spans eight pages, details several compliance issues observed during an inspection. Notably, it mentions an incident where an employee attempted to divert inspectors…
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Hainan Poly Pharm’s Manufacturing Units Get GMP Nod From Saudi Food and Drug Authority
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, announced that it has received a GMP certificate from the Saudi Food and Drug Authority (SFDA). The GMP certification covers seven pharmaceutical varieties registered in Saudi Arabia, including eptifibatide, nitroprusside, folinic acid, ganciclovir, azithromycin, cyclophosphamide, and levetiracetam. A total…
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Swiss Pharma Firm Carbogen Amcis Receives Brazil’s ANVISA GMP Certification for Shanghai Site
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Carbogen Amcis, a Swiss firm specializing in active pharmaceutical ingredients (APIs) and pharmaceutical process development, has announced that its Shanghai facility has successfully passed its inaugural routine inspection by Brazil’s National Health Surveillance Agency (ANVISA). The five-day inspection in November 2023 has resulted in the site being awarded Good Manufacturing…
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FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
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The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio Pharmaceutical Co., Ltd., a China-based active pharmaceutical ingredient (API) manufacturer, following an on-site inspection that revealed significant deviations from current Good Manufacturing Practice (cGMP) standards. The FDA’s letter underscores Deebio’s shortcomings in properly documenting laboratory…
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WuXi XDC Partners with Celltrion to Support Global Development and Manufacturing of Bioconjugated Drugs
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a cooperation memorandum of understanding (MOU) with South Korean firm Celltrion Inc. (KRX: 068270) to provide comprehensive services for the development and manufacturing of…
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China’s NMPA Proposes Enhanced IT and Visualization Requirements for Blood Product GMP
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The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the revised draft proposal for the annex amendment of the Good Manufacturing Practice (GMP) standards for blood products. This updated version introduces new requirements focusing on information technology and visualization in the manufacturing and testing processes…
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Aurobindo Pharma’s China Plant Secures EU GMP Approval, Eyes Revenue Generation
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India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week, as reported by The Hindu Times. The site is anticipated to start generating revenues from the end of Q4 of the company’s fiscal year (FY) 2024 or early in Q1 FY 2025. Manufacturing and Market…
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Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of…
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Gritgen Therapeutics Commences Operations of Commercial GMP Facilities in Suzhou
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Suzhou-based gene therapy specialist, Gritgen Therapeutics Co., Ltd, has announced the validation completion and initiation of operations at its commercial Good Manufacturing Practice (GMP) facilities located in the Suzhou Industrial Park. This development marks a significant step forward for the company in advancing its capabilities in gene therapy production. Facility…
