Linagliptin API Made in Iran
Iranian linagliptin API is a pharmaceutical-grade active pharmaceutical ingredient (API) manufactured under strict GMP conditions. This white to off-white crystalline powder is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the treatment of type 2 diabetes mellitus. The API is available in USP, BP, and EP grades and is suitable for the manufacture of immediate-release tablets and combination products with metformin. All products are manufactured under licenses from the Iranian Ministry of Health and Medical Education (MOHME), with GMP certification, and in full compliance with all required pharmaceutical production standards.
The Supply Chain Department at Sahi Rasa Company supplies Iranian linagliptin API for export to Afghanistan, Iraq, the Kurdistan Region, Tajikistan, Uzbekistan, Armenia, Georgia, Turkey, Syria, Oman, Kuwait, Jordan, and Russia. In addition to the API, the department offers blister materials, caps, dosing cups, dosing spoons, syringes and needles, and complete labeling services.
1. Introduction to the Supply Chain Department at Sahi Rasa Company
The Supply Chain Department at Sahi Rasa Company has developed a specialized expertise in the export of active pharmaceutical ingredients (APIs), and linagliptin represents an important product in its portfolio for diabetes therapy. The department understands that linagliptin is a widely prescribed DPP-4 inhibitor used for type 2 diabetes, and that the API must meet stringent purity standards. A pharmaceutical manufacturer in Turkey requires linagliptin API that meets USP, BP, or EP standards and is suitable for tablet manufacturing; a generic drug manufacturer in Iraq needs linagliptin API for combination formulations with metformin; a contract manufacturer in Oman requires linagliptin API that meets GCC regulatory requirements; a pharmaceutical company in Jordan requires linagliptin API that maintains stability over shelf life.
The department sources linagliptin API from qualified Iranian manufacturers who operate under GMP conditions and hold licenses from the Iranian Ministry of Health and Medical Education (MOHME). These manufacturers use validated synthesis processes, and their facilities are subject to regular inspections. The API is available in USP, BP, and EP grades, with controlled particle size distribution. The API is tested for assay, impurities, residual solvents, heavy metals, and microbial contamination. Certificates of Analysis are provided with every shipment.
Important Notice: The ordering company must be a licensed pharmaceutical manufacturer and must possess all necessary documentation for importing this API into the destination country, including import permits and GMP compliance certificates.
For clients in Afghanistan, the Kurdistan Region, Iraq, Tajikistan, Uzbekistan, Armenia, Georgia, Turkey, Syria, Oman, Kuwait, Jordan, and Russia, the Supply Chain Department at Sahi Rasa Company offers a reliable and flexible supply of linagliptin API in USP, BP, and EP grades, along with complete packaging solutions.
Disclaimer: Please note that the analyses and specifications provided in this document are indicative and may vary depending on the specific product available at the time of order. For exact analysis and specifications tailored to your requirements, please contact us directly.
2. Product Overview
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used for the treatment of type 2 diabetes mellitus. The API is a white to off-white crystalline powder with a molecular formula of C₂₅H₂₈N₈O₂ and a molecular weight of 472.54 g/mol. It is available in USP, BP, and EP grades.
Material Options:
Standard Grade: Fine powder for immediate-release tablet manufacturing.
Combination Grade: Fine powder for combination tablet manufacturing.
Primary Applications:
Type 2 Diabetes: The API is used for manufacturing antidiabetic products.
Combination Products: The API is used for manufacturing combination products with metformin.
Immediate-Release Tablets: The API is used for manufacturing immediate-release tablets.
3. Physical Specifications Table
| Parameter | Standard Grade | Combination Grade |
|---|---|---|
| Product Name | Linagliptin API | Linagliptin API |
| Chemical Formula | C₂₅H₂₈N₈O₂ | C₂₅H₂₈N₈O₂ |
| Appearance | White to off-white crystalline powder | White to off-white crystalline powder |
| Assay | 99.0–101.0% | 99.0–101.0% |
| Particle Size | Fine powder | Fine powder |
| Bulk Density | 0.3–0.5 g/mL | 0.3–0.5 g/mL |
| Moisture Content | ≤ 0.5% | ≤ 0.5% |
| Packaging | 25 kg bags | 25 kg bags |
4. Chemical Specifications Table
| Component | Specification |
|---|---|
| Assay | 99.0–101.0% |
| Heavy Metals | ≤ 20 ppm |
| Residual Solvents | Within USP/BP/EP limits |
| Related Substances | Within USP/BP/EP limits |
| Loss on Drying | ≤ 0.5% |
| Melting Point | 202–206°C |
| pH | 5.0–7.0 |
| Microbial Contamination | ≤ 1000 CFU/g |
| E. coli | Absent |
| Salmonella | Absent |
| GMP Compliance | Yes |
| MOHME License | Yes |
5. Industries & Factories Using This Product
Iranian linagliptin API is used across a wide range of pharmaceutical industries.
Pharmaceutical Industry: Branded and generic pharmaceutical manufacturers use linagliptin API for manufacturing immediate-release tablets and combination products.
Contract Manufacturing Industry: Contract manufacturers use linagliptin API for producing finished dosage forms on behalf of pharmaceutical companies.
The Supply Chain Department at Sahi Rasa Company serves clients in all these industries.
Disclaimer: Please note that the analyses and specifications provided in this document are indicative and may vary depending on the specific product available at the time of order. For exact analysis and specifications tailored to your requirements, please contact us directly.
6. Key Properties & Advantages
Iranian linagliptin API offers high assay (99.0–101.0%), USP, BP, and EP grades, controlled particle size, low impurities, GMP compliance, MOHME licensing, competitive pricing, and reliable supply.
7. Chemical Formula / Size & Packaging Specifications
Chemical Formula: C₂₅H₂₈N₈O₂
Molecular Weight: 472.54 g/mol
CAS Number: 668270-12-0
Packaging Options: 25 kg bags
8. Available Grades, Sizes, Qualities & Custom Colors
| Grade | Standard | Particle Size | Application |
|---|---|---|---|
| Standard | USP/BP/EP | Fine powder | Tablets |
| Combination | USP/BP/EP | Fine powder | Combination tablets |
Quality Grades: Pharmaceutical Grade. Custom Options: Custom particle sizes and packaging available.
9. Sahi Rasa Supply Chain Department Services for International Factories
The department provides monthly supply planning, sourcing, sample dispatch, custom manufacturing, pre-shipment QC, loading, export documentation, international transportation, customs clearance, on-site technical support, and training.
Complete Packaging Package:
APIs: Various APIs including linagliptin, sitagliptin, and others.
Folding Cartons: Various sizes and designs for pharmaceutical, food, cosmetic, and other industries.
Cardboard Boxes and Cartons: Various sizes and designs for pharmaceutical, food, cosmetic, and other industries.
Custom Molds and Shapes: Available through the Industrial Design Department.
Label and Box Services: Custom label design, printed cardboard boxes, patient information leaflets, graphic design, print supervision, and label roll configuration.
Blister Materials: Aluminum, PVC, micro-PVC, PVDC in various microns.
Caps: Child-proof (CR) and regular caps.
Dosing Cups and Spoons: Graduated for accurate measurement.
Syringes and Needles: Various sizes and gauges.
Disclaimer: Please note that the analyses and specifications provided in this document are indicative and may vary depending on the specific product available at the time of order. For exact analysis and specifications tailored to your requirements, please contact us directly.
10. Why Choose the Supply Chain Department at Sahi Rasa Company?
The department offers high-quality linagliptin API, USP, BP, and EP grades, controlled particle size, GMP compliance, MOHME licensing, competitive pricing, and reliable export services to clients in Afghanistan, Iraq, Kurdistan, Tajikistan, Uzbekistan, Armenia, Georgia, Turkey, Syria, Oman, Kuwait, Jordan, and Russia.
11. Ordering & Contact Information
Important Notice: API products are not commercial products. They are only available for orders from licensed pharmaceutical manufacturing plants in destination countries that hold all legal permits and import documentation required for these products. Orders from non-licensed entities cannot be processed.
International customers can place orders through the Request for Quotation (RFQ) form located at the bottom of this page. The expert team at the Supply Chain Department at Sahi Rasa Company will respond to all inquiries as soon as possible, providing complete information on pricing, delivery schedules, shipping terms, and export documentation.
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