Double Brilliance! Thinheal Pharma’s Peptide Manufacturing Base Receives EU Export Certificate for Tirzepatide API
Following the receipt of EU export certification for its Semaglutide API, Thinheal Pharma’s peptide manufacturing facility has
once again received good news. The company’s GMP manufacturing base in Shaoxing, Zhejiang—Zhejiang Tasln Biopharma Co., Ltd.—
has officially been issued an "Export Certificate for Active Pharmaceutical Ingredients (APIs) to the EU" (Certificate No.: ZJ260050) by the
Zhejiang Provincial Medical Products Administration.
This certification specifically designates the product—Tirzepatide Active Pharmaceutical Ingredient (API)—marking the
official and authoritative recognition of Thinheal Pharma’s compliant manufacturing capabilities within the highly competitive
GLP-1/GIP dual-target therapeutic space.
Official Certification: GMP Standards Equivalent to EU Standards
According to certification documents issued by the Zhejiang Medical Products Administration, the GMP system implemented at Thinheal Pharma's manufacturing facility complies with both Chinese GMP requirements for pharmaceuticals and the ICH Q7 GMP guidelines. Furthermore, the company has successfully passed the EU import and export certification inspection, thereby confirming that its products are eligible for official export to the European Union.
This means:
The Tirzepatide API manufactured by Thinheal Pharma possesses the key qualifications required for entry into the European Union and other international markets that recognize EU standards.
The Quality Management System at our manufacturing facility is fully aligned with leading international standards; from plant infrastructure and production processes to quality control, all aspects meet the requirements of authoritative international bodies.
The company possesses the capability to serve the world's most stringently regulated markets, thereby providing our international partners with comprehensive regulatory compliance assurance.
Tirzepatide: The New Tailwind in the Peptide Sector
As the world's first approved GIP/GLP-1 dual receptor agonist, tirzepatide has demonstrated clinical advantages in the treatment of Type 2 diabetes and weight loss that surpass those of single-target medications, earning it acclaim as the "next-generation blockbuster metabolic drug." With global market demand for tirzepatide continuing to surge, the stable supply of high-quality active pharmaceutical ingredients (APIs) has emerged as a critical link in the industry value chain.
The attainment of this certification signifies that Thinheal Pharma is now able to supply global partners with Tirzepatide APIs—ranging in scale from grams to hundreds of kilograms—that meet international quality standards, thereby robustly supporting the development of various drug formulations as well as commercial manufacturing requirements.
Bolstered by Dual Certification: Solidifying CRDMO Service Capabilities
Notably, Thinheal Pharma’s peptide manufacturing facility has successively obtained EU API export certificates for two blockbuster peptide drugs: Semaglutide and Tirzepatide. This achievement not only signifies the regulatory authorities' high recognition of the continuous and stable operation of Thinheal Pharma’s quality management system, but also underscores the company’s platform-based capabilities and regulatory compliance expertise within the field of peptide CDMO.
“The fact that two of our core products have successively obtained export certification for the EU serves as the ultimate validation of our ‘high-standard, internationalized’ quality strategy,” stated a representative from Thinheal Pharma. “Moving forward, the company will leverage this milestone to further strengthen the development of its quality management systems, offering global partners comprehensive, highly compliant peptide CRDMO services—spanning the entire spectrum from R&D to manufacturing—backed by internationally recognized standards of excellence.”
