High-Purity Incretin-Class Peptide Active Pharmaceutical Ingredient for Metabolic Therapeutics
Tirzepatide API (CAS 2023788-19-2) is an active pharmaceutical ingredient in the GLP-1 / Incretin-Class Peptide API category, manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra, India. It is supplied in IP/BP/EP/USP pharmacopeial grades, with MOQ starting at 1 kg for sampling and 25 kg for commercial bulk orders, full CoA/MSDS documentation, and export support to USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white lyophilized powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Get Bulk Quote for Tirzepatide API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Tirzepatide API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.
Our manufacturing and supply approach for Tirzepatide emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Tirzepatide is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Tirzepatide API is manufactured under WHO-GMP certified processes with in-house quality control covering identification, assay, related substances, and heavy-metal testing for every batch. Each shipment is released against a Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS), with DMF-grade dossier support (stability data and Genotoxic Impurity Report) available for USFDA, EMA, and CDSCO regulatory submissions.
Swapnroop exports Tirzepatide API to pharmaceutical buyers across USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets, with export documentation, phytosanitary/regulatory paperwork, and logistics coordination handled for both sea and air freight consignments.
We offer Tirzepatide in pharma-oriented packaging formats with cold-chain-compatible containers and inner protection layers, helping maintain peptide integrity during storage, shipping, and routine supply movement.
Get Bulk QuoteShare your required quantity and pharmacopeial grade via WhatsApp or email.
We share CoA, MSDS, and applicable DMF-grade documents for evaluation.
Confirm a 1 kg sample or place a commercial bulk order (25 kg+).
Standard lead time is 2–4 weeks with full export documentation handled.
“Reliable supplier of Tirzepatide API. Consistent quality with full CoA documentation and on-time delivery.”
— Quality Assurance Head
“Batch-to-batch consistency for Tirzepatide API has been dependable across multiple commercial orders.”
— Regulatory Affairs Manager
Other APIs available from Swapnroop Pharma
The CAS number for Tirzepatide API is 2023788-19-2. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Tirzepatide API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC-verified purity. All batches include full CoA, MSDS, and pharmacopeial identification testing.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply of Tirzepatide API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Tirzepatide API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Tirzepatide is packaged in cold-chain-compatible, moisture-protected containers suited to peptide handling. Storage and transport recommendations are shared with every batch to support stability during transit.
For companies evaluating Tirzepatide API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.
Our team works with buyers who need Tirzepatide API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.