As the core intermediate P29 of Semaglutide, Arg34-GLP-1 is under strict pharmaceutical grade control, focusing on GMP compliance, qualification review and application supervision. Internationally, comply with EU EDQM and US FDA requirements with CEP, DMF and other compliance documents provided. In China, obtain Drug Production License and GMP certification. Focus on reviewing supplier pharmaceutical qualifications and pharmacopoeia-grade test reports, standardize aseptic packaging, cold chain transportation and labeling, strictly control impurities and application compliance. Contracts shall specify full-chain traceability, liability division and recall clauses to ensure the product is only used for legal pharmaceutical production and complies with global pharmaceutical intermediate supervision requirements.
EU: As pharmaceutical intermediate, comply with EDQM requirements; CEP certificate and GMP certification are required. Production shall follow ICH Q7 standards; impurity control shall meet EP (European Pharmacopoeia) requirements. Import shall complete pharmaceutical filing and non-pharmaceutical application is prohibited.
US: Comply with FDA regulatory requirements; suppliers shall complete DMF (Drug Master File) filing and GMP certification. Purity and impurities shall meet USP (United States Pharmacopoeia) standards; DMF filing number and relevant compliance documents shall be submitted for import; illegal circulation is prohibited.
China: As pharmaceutical intermediate (for Semaglutide API production), comply with Good Manufacturing Practice for Pharmaceutical Products (GMP) and Chinese Pharmacopoeia 2025 Edition; obtain Drug Production License. Import shall complete pharmaceutical import filing; application in food, health food and illegal resale are prohibited.
Business License (business scope covering pharmaceutical intermediate, API production/sales); Drug Production License, GMP certification (core qualifications); CEP certificate (EU market), DMF filing documents (US market).
COA (pharmacopoeia standard, purity ≥99%, related substances ≤0.5%), impurity test report, stability test report; ISO 9001, ISO 13485 certification.
Overseas suppliers shall provide production licenses issued by local pharmaceutical regulatory authorities and inspection & quarantine certificates to ensure production complies with international GMP standards.
R&D centers and production workshops shall pass on-site inspections by corresponding national regulatory authorities (FDA, EDQM).
Packed in 1kg/5kg sealed aluminum foil bag plus aseptic cardboard drum with aseptic packaging; marked with Pharmaceutical intermediate, only for pharmaceutical production, not for direct oral administration.
Chinese-English bilingual labels include product name, batch number, purity, production date, validity period, storage conditions (refrigeration at 2–8℃), GMP marking and production license number.
Full cold chain transportation at 2–8℃, light-proof, shockproof and pollution-proof. Copies of GMP certificate, COA, impurity test report and cold chain records shall be accompanied with the shipment.
Mixed transportation with food and cosmetics is prohibited to ensure product stability during transit.
Strictly control impurities (related substances, heavy metals, microorganisms, residual solvents) to meet pharmacopoeia standards; toxic and harmful impurities are prohibited.
Application in non-pharmaceutical fields such as food, health food and cosmetics as well as illegal resale are strictly prohibited.
Aseptic operation shall be adopted in production, storage and transportation to avoid pollution.
Batch traceability covers the whole chain of raw material procurement, production, testing and transportation; complete test records and traceability files shall be kept for each batch.
Conduct regular stability tests to ensure qualified quality within validity period and avoid deterioration caused by improper storage.
Clarify product application (only for Semaglutide API production), pharmacopoeia standard (EP/USP/Chinese Pharmacopoeia), purity and impurity limit.
Agree that suppliers shall provide authentic and valid GMP, CEP, DMF and other qualification documents to meet pharmaceutical intermediate regulatory requirements.
Specify cold chain transportation liability and full batch traceability requirements; stipulate recall and destruction clauses for non-conforming products, clarify punishment and compensation liabilities caused by illegal application, unqualified qualifications and substandard quality.
Suppliers are prohibited from arbitrarily changing production processes or lowering quality standards.
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