Tacrolimus Monohydrate API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in immunosuppressive pharmaceutical formulations for organ transplantation and autoimmune disease management. Tacrolimus Monohydrate is a calcineurin inhibitor that suppresses T-lymphocyte activation, making it one of the most effective immunosuppressive agents used in kidney, liver, heart, and other solid organ transplant therapies. It is also extensively utilized in dermatological formulations for the treatment of atopic dermatitis and other inflammatory skin disorders.
MEDIOCON INC is a trusted Tacrolimus Monohydrate API manufacturer and bulk supplier in India, supplying high-purity pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities utilize advanced production technologies and stringent quality management systems to ensure superior purity, batch-to-batch consistency, and compliance with international pharmaceutical standards.
Every batch of Tacrolimus Monohydrate API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, microbial limits, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical quality specifications.
Our Tacrolimus Monohydrate API is available in USP, EP, JP, IP, and Pharmaceutical Grade, making it suitable for immunosuppressive drug formulations, transplantation medicine, dermatological formulations, analytical testing, formulation development, quality control laboratories, stability studies, and pharmaceutical process validation. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring smooth procurement and regulatory compliance.
With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and dedicated technical support, we ensure reliable worldwide delivery of premium-quality Tacrolimus Monohydrate API.
If you are looking for a reliable Tacrolimus Monohydrate API manufacturer, exporter, and bulk supplier, MEDIOCON INC offers pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR, HPLC & UV Complies |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Specific Rotation | −110° to −125° (c = 1, Chloroform) |
| Melting Point | 126°C – 130°C |
| Solubility | Practically Insoluble in Water; Freely Soluble in Methanol, Ethanol, Chloroform, and Acetonitrile |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Tacrolimus Monohydrate API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 109581-93-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Tacrolimus Monohydrate API Manufacturer & Bulk Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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