Jiangsu Hengrui Pharmaceuticals Receives FDA Form 483 Following Inspection Discrepancies
The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui...
GMP / GCP / GSP
Hainan Poly Pharm’s Manufacturing Units Get GMP Nod From Saudi Food and Drug Authority
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, announced that it has...
Swiss Pharma Firm Carbogen Amcis Receives Brazil’s ANVISA GMP Certification for Shanghai Site
Carbogen Amcis, a Swiss firm specializing in active pharmaceutical ingredients (APIs) and pharmaceutical process development,...
FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio...
WuXi XDC Partners with Celltrion to Support Global Development and Manufacturing of Bioconjugated Drugs
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA,...
China’s NMPA Proposes Enhanced IT and Visualization Requirements for Blood Product GMP
The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the...
Aurobindo Pharma’s China Plant Secures EU GMP Approval, Eyes Revenue Generation
India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week,...
Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech,...
Gritgen Therapeutics Commences Operations of Commercial GMP Facilities in Suzhou
Suzhou-based gene therapy specialist, Gritgen Therapeutics Co., Ltd, has announced the validation completion and initiation...
SCG Cell Therapy Launches Global Manufacturing and R&D Center in Singapore with Automated System
Singapore-based SCG Cell Therapy Pte. Ltd has announced the initiation of its global manufacturing and...
Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar...
Mustang Bio, Inc. Enters Strategic Partnership with uBriGene for Cell and Gene Therapy
US-based Mustang Bio, Inc. has announced a strategic partnership with uBriGene (Boston) Biosciences Inc., the...
Full-Life Technologies Ltd to Establish GMP-Compliant Radiopharmaceutical Plant in Belgium’s Wallonie Region
Shanghai-headquartered Full-Life Technologies Ltd has announced a significant land acquisition deal in the Wallonie region...
China Issues New Ethical Review Measures for Life Sciences and Medical Research
The National Health Commission, Ministry of Education, Ministry of Science and Technology, and National Administration...
Huahai Pharma Raises Funds for Digital Manufacturing and API Platform
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) plans to raise RMB 1.56 billion (USD...
Clover Biopharmaceuticals Secures Exclusive Deal for AdimFlu-S Distribution in China
China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has announced an exclusive agreement with Adimmune Corporation for...
WuXi Biologics Receives First GMP Certificate from Ireland HPRA
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced receiving...
China’s NMPA Seeks Feedback on Drug Quality Management Provisions
China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Provisions on the...
Ascentage Pharma Receives Drug Production License for Suzhou Plant
Suzhou-based Ascentage Pharma (HKG: 6855) has announced receiving a Drug Production License (A license) following...
Biosyngen to Establish Cell Therapy GMP Facility in Singapore
Biosyngen has announced plans to establish a Cell Therapy GMP Facility in Singapore, aimed at...