WHO-GMP Certified Active Pharmaceutical Ingredient Supplier
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline 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% |
Alogliptin API (CAS 850649-61-5) is an active pharmaceutical ingredient classified as a dpp-4 inhibitor, used in the treatment of type 2 diabetes mellitus. As a leading Alogliptin API supplier and manufacturer in India, Swapnroop Drugs & Pharmaceuticals ensures high purity, consistent quality, and full compliance with international pharmacopeial standards for global regulated and semi-regulated markets.
Pharmaceutical companies sourcing Alogliptin API evaluate HPLC purity (≥98.0%), impurity profile control (ICH Q3A compliant), residual solvent content (ICH Q3C), and polymorphic form consistency. Batch-to-batch reproducibility in particle size distribution (D90, D50) is critical for consistent dissolution performance and tablet compressibility in downstream formulation.
Swapnroop Drugs and Pharmaceuticals supplies Alogliptin API from our WHO-GMP certified Aurangabad facility with complete IP/BP/EP/USP pharmacopeial compliance. We support ANDA/NDA filing through DMF-referenced documentation, provide fresh monthly batches with validated shelf life, and export to 25+ countries with full regulatory dossier support.
Alogliptin API is supplied in triple-layer HDPE drums (5 kg, 10 kg, 25 kg) with moisture barrier inner bags and nitrogen purge to preserve API purity and pharmacopeial compliance during storage and international transit.
Get Bulk QuoteThe CAS number for Alogliptin API is 850649-61-5. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers.
Alogliptin API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC assay 98.0–102.0%, full impurity profiling per ICH Q3A, and pharmacopeial identification testing (IR, HPLC).
Minimum order is 1 kg for R&D sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply available for urgent requirements.
Yes, Swapnroop provides full DMF-grade documentation for Alogliptin API including CoA, MSDS, impurity report, stability data, and complete regulatory dossier support for USFDA, EMA, and CDSCO submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Alogliptin API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Alogliptin API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Alogliptin API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Alogliptin API pricing, samples, and sourcing support.