Boehringer Ingelheim Gains Approval for Supply of EU and US Markets

Boehringer Ingelheim Gains Approval for Supply of EU and US Markets

By, Admin 10 April 2024

Boehringer Ingelheim Biopharmaceuticals China receives approval for supply of EU and US markets

Overview

Boehringer Ingelheim Biopharmaceuticals China (BioChina), in collaboration with a customer, has successfully passed pre-approval inspections by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Approval for Transforming Lives

  • As a result, the customer is now approved for the supply of the biopharmaceutical to the EU and US markets from product manufactured by Boehringer Ingelheim Biopharmaceuticals China. 
  • The inspections validated compliance with ICH, GxP regulations, international manufacturing standards, and patient safety requirements at Boehringer Ingelheim’s OASIS manufacturing site in Shanghai.  
  • As part of the Boehringer Ingelheim Biopharmaceutical’s global manufacturing network, BioChina continues to uphold the corporate values and commitment to providing safe, effective, and high-quality medications. 
  • “For us as a world-leading contract manufacturer of biopharmaceuticals, the official approvals for our site are a confirmation of our own aspiration to transform lives for generations,” explains Ulrike Falk, head of global quality biopharma operations at Boehringer Ingelheim.

Boehringer Ingelheim’s contract manufacturing activities in China, began in 2013, as a pioneer under a new regulatory framework of the CMO/MAH trial project by the local authority, National Medical Products Administration (NMPA).

First Authorization Holder

  • Through its collaboration and the provision of manufacturing services for this biopharmaceutical, Boehringer Ingelheim Biopharmaceuticals China was the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL). 
  • As a result, this customer product is the first innovative biologic commissioned under the new MAH model in China.

Words from Boehringer Ingelheim

“With recent approvals of this biologic by renowned health authorities including EMA, MFDS, and now the FDA, BioChina continues on a transformative journey supplying our long-time partner in expanding global reach. By offering our partner top-tier quality products, BioChina is fully devoted to improving the lives of patients worldwide,” states Dr. Yuguo Zang, head of BioChina at Boehringer Ingelheim.

This important milestone underscores Boehringer Ingelheim's capabilities in high quality manufacturing services to support local partners with global patient supplies.

On Breakthrough Therapies

  • Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. 
  • As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need.

Boehringer Ingelheim BioXcellence

  • Boehringer Ingelheim BioXcellence creates solutions with its customers to reliably supply innovative therapies. 
  • One of the world’s largest manufacturers of biopharmaceuticals and an industry pioneer with in-depth experience, Boehringer Ingelheim BioXcellence so far has supplied more than 40 commercial products through its global network.

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