WuXi Biologics receives GMP certification from Brazil's ANVISA

▴ WuXi Biologics receives GMP certification from Brazil's ANVISA
The positive assessment from ANVISA reaffirms WuXi Biologics' strong commitment to offering partners a global manufacturing network of the highest standard

WuXi Biologics, a global company with leading open-access biologics technology platforms, today announced that it has received the Good Manufacturing Practice (GMP) certification from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The positive assessment from ANVISA reaffirms WuXi Biologics' strong commitment to offering partners a global manufacturing network of the highest standard.

This is WuXi Biologics' third GMP certification from drug regulatory authorities, and distinguishes it as the first company in China to receive authorizations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and ANVISA to manufacture biologics. To date, WuXi Biologics' facilities in Wuxi city, Shanghai and Suzhou have passed a total of six GMP inspections conducted by these regulatory agencies.

"We are very excited to have reached another regulatory milestone during this challenging year. This achievement once again demonstrates WuXi Biologics' high-quality services, which have been widely recognized by regulatory authorities. We owe this achievement to our partners' trust in our capabilities and our team's tireless commitment to excellence," commented Dr Chris Chen, CEO of WuXi Biologics. "As outsourcing demand increases around the world, we have made huge strides in expanding our services globally and plan to increase our total biomanufacturing capacity to 300,000 liters after 2023. WuXi Biologics will continue to enable our global partners throughout the development and manufacturing process to provide life-saving treatments to patients worldwide."

WuXi Biologics, a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.

Tags : #WuXiBiologics #LatestNewsonWuXiBiologics28thDec #LatestPharmaNews28thDec #LatestGMPCertification #USFDA #EuropeanMedicinesAgency

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

The Role of Genetic Profiles in Alzheimer’s Therapy: APOE4 and Treatment ResponsesMay 08, 2024
Assessing Covishield Safety: Indian Research Offers Reassurance Amidst Rare Side Effect DiscussionsMay 08, 2024
Quadria Capital Invests $102 Million in NephroPlus to Boost Dialysis Services Across AsiaMay 08, 2024
Reducing Stigma, One Story at a Time: Media's Role in Mental HealthMay 07, 2024
When Your Body Makes Beer: Exploring the Curious Case of Auto-Brewery SyndromeMay 07, 2024
Hair Today, Gone Tomorrow: Why Guys Go Bald Before Marriage May 07, 2024
Menopausal Transitions and Mental Health: UCL Study Highlights Increased Depression RiskMay 07, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Harnessing AI for Early Alzheimer's Disease Diagnosis: IIT Indore's BreakthroughMay 06, 2024
Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny: Understanding the ObservationsMay 06, 2024
Exploring the Role of Mediator Protein Complex in Cell Division: Implications for Disease ManagementMay 06, 2024
Akshay Tritiya Parna Mahotsav is to be held in the cityMay 04, 2024
Bharti Singh's Battle with Gallstones: Symptoms, Precautions, and Natural RemediesMay 04, 2024
Empowering Women's Health: New Mammogram GuidelinesMay 04, 2024
Rising Temperatures, Rising Risks: Addressing the Challenges of Heat StressMay 04, 2024
Gynoveda, India's First Ayurveda Fertility Company, Expands Reach with New Clinic in Pune, Set to Open 100 Clinics Across India by 2027May 03, 2024
Aptus Value Housing Finance India Limited, a leading Housing Finance Company has declared its financial results for the year ended March 31, 2024. FY 24 ResultsMay 03, 2024
TIPS FOR PREGNANCY CARE DURING SUMMERMay 03, 2024
The deadly intersection: TB and tobacco smoking co-epidemics in Indonesia Dr TARA SINGH BAM – CNSMay 03, 2024