GENERIC NAME OF THE MEDICINAL PRODUCT:
Sitagliptin Phosphate Tablet USP 50mg
Sitagliptin Phosphate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………... 25mg
Excipients……………………………………q.s.
Colurs: Iron oxide Yellow
b) Sitagliptin Phosphate Tablet USP 50mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………... 50mg
Excipients……………………………………q.s.
Colurs: Iron oxide Red
c) Sitagliptin Phosphate Tablet USP 100mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………... 100mg
Excipients……………………………………q.s.
Colors: Quinoline Yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Sitagliptin Phosphate Tablet 50mg Technical Specification:
| Product Name: |
Sitagliptin Phosphate Tablet USP |
| Brand Name: | Generics |
| Strength: | (25mg), (50mg), (100mg) |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidiabetic, Diabetology |
| Indication: | Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sitagliptin Phosphate Tablet USP 25mg
- Sitagliptin Phosphate Tablet USP 50mg
- Sitagliptin Phosphate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Sitagliptin Phosphate Tablet USP 25mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 25mg
Excipients……………………………………q.s.
Colurs: Iron oxide Yellow - b) Sitagliptin Phosphate Tablet USP 50mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 50mg
Excipients……………………………………q.s.
Colurs: Iron oxide Red - c) Sitagliptin Phosphate Tablet USP 100mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 100mg
Excipients……………………………………q.s.
Colors: Quinoline Yellow
THERAPEUTIC INDICATIONS:
- Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).
CAUTION & WARNING:
- CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
- Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
- Dosage:As directed by the Physician.
Introduction to Sitagliptin Phosphate Tablet 50mg
Sitagliptin Phosphate Tablet 50mg is a widely prescribed oral antidiabetic medication used in the management of Type 2 Diabetes Mellitus. It belongs to the DPP-4 inhibitor class, which helps regulate blood sugar levels by increasing insulin release and reducing glucose production in the liver. Typically, it is used in combination with diet and exercise, and sometimes with other antidiabetic drugs, to achieve optimal glycemic control.
The global demand for Sitagliptin Phosphate is rising significantly due to the increasing prevalence of diabetes and the shift towards more effective, low-side-effect medications. With markets expanding rapidly in Asia, Africa, Latin America, and Europe, the role of a reliable manufacturer and exporter becomes crucial — and this is where Taj Pharma stands out as a market leader.
Detailed Insights for Importers, Exporters & Buyers
Taj Pharma, headquartered in Vapi, Gujarat, India, has built a global reputation for delivering Sitagliptin Phosphate Tablet 50mg that meets stringent international standards. For overseas buyers and distributors, the company offers complete support to ensure smooth regulatory approvals, high-quality packaging, and long shelf-life.
1. Regulatory Documentation Provided
To facilitate seamless registration and import in different markets, Taj Pharma provides:
-
WHO-GMP / EU-GMP certificates
-
Certificate of Pharmaceutical Product (COPP)
-
Free Sale Certificate (FSC)
-
DMF / CTD Dossier
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Stability Data & Bioequivalence Reports
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Product Sample & COA (Certificate of Analysis)
2. Custom Packaging & Labeling
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Blister packs, bottles, or strips as per market requirements
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Multi-language labeling for exports (English/French/Spanish/Arabic etc.)
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Tamper-evident, moisture-proof packaging
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Branding support for PCD Pharma Franchise partners
3. Shelf-life, Storage & Dosage Form
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Shelf-life: 24–36 months
-
Storage: Store below 30°C, protect from moisture and light
-
Dosage Form: Film-coated tablet containing Sitagliptin Phosphate equivalent to 50mg Sitagliptin
4. Export Certifications
Taj Pharma meets all major global compliance requirements:
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WHO-GMP Approved
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EU-GMP Compliant Manufacturing
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ISO 9001:2015 Certified
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COPP & FSC for Global Registration
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CTD / ACTD Dossier Ready for Submission
5. Target Countries & Export Markets
Taj Pharma actively exports Sitagliptin Phosphate Tablet 50mg to over 40 countries, including:
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Asia: Vietnam, Philippines, Sri Lanka, Myanmar
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Africa: Kenya, Nigeria, Ghana, Ethiopia, South Africa
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Middle East: UAE, Oman, Yemen, Saudi Arabia
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CIS Countries: Kazakhstan, Uzbekistan, Ukraine
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Latin America: Peru, Chile, Bolivia, Guatemala
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
1. State-of-the-Art Manufacturing
Taj Pharma operates WHO-GMP and EU-GMP approved facilities with advanced quality control laboratories. Each batch of Sitagliptin Phosphate Tablet 50mg undergoes stringent testing for purity, potency, and dissolution rate.
2. Affordable Pricing & Quality Assurance
The company ensures competitive pricing without compromising on international quality standards — a major advantage for global importers aiming to expand market share.
3. Global Presence & Supply Chain
With a robust export network, Taj Pharma ensures timely delivery to every corner of the world, maintaining product stability and safety during transit.
4. Top 20 Exporting Countries
Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia
Technical Product Specification
| Parameter | Specification |
|---|---|
| Product Name | Sitagliptin Phosphate Tablet 50mg |
| Dosage Form | Film-coated tablet |
| Active Ingredient | Sitagliptin Phosphate Monohydrate |
| Strength | 50mg |
| Appearance | Round, film-coated tablet |
| Packaging | 10×10 blister pack / bottle |
| Shelf Life | 24–36 months |
| Storage | Below 30°C, away from light & moisture |
| Compliance | WHO-GMP, EU-GMP, ISO 9001:2015 |
| Indication | Type 2 Diabetes Mellitus |
| Administration | Oral, once daily |
| Manufacturer | Taj Pharma, India |
If you are a pharmaceutical distributor, importer, or PCD Pharma Franchise seeker, Taj Pharma offers high-quality Sitagliptin Phosphate Tablet 50mg at the most competitive prices with full export documentation.
📧 Email: export@tajpharma.com
🌐 Website: www.tajpharma.com
Top 20 FAQs
1. What is Sitagliptin Phosphate Tablet 50mg used for?
It is used to lower blood sugar levels in adults with Type 2 Diabetes Mellitus.
2. How does Sitagliptin work?
It inhibits the DPP-4 enzyme, increasing insulin release and decreasing glucagon levels.
3. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma’s facility is WHO-GMP & EU-GMP compliant.
4. Can Sitagliptin be taken during pregnancy?
Generally not recommended; consult a doctor.
5. What is the shelf life of Sitagliptin Phosphate 50mg?
24–36 months when stored properly.
6. Does Taj Pharma offer custom packaging?
Yes, with multi-language labeling options.
7. Can I import Sitagliptin from India?
Yes, Taj Pharma provides COPP, FSC, and full dossiers for registration.
8. Are samples available for testing?
Yes, upon request.
9. What are common side effects?
Mild headache, nasopharyngitis, or upper respiratory infection.
10. Can it be taken with other diabetes medicines?
Yes, under medical supervision.
11. Is it safe for long-term use?
Yes, when taken as prescribed.
12. How is it packaged for export?
Blister packs or bottles in export-grade cartons.
13. Does Taj Pharma export to Africa?
Yes, to multiple African nations.
14. Is pricing competitive for bulk orders?
Yes, bulk orders get preferential pricing.
15. Does it require refrigeration?
No, store at room temperature.
16. Is it available for PCD franchise?
Yes, across India.
17. What is the dosage?
One 50mg tablet daily, as prescribed.
18. Can children take Sitagliptin?
Not recommended for children under 18.
19. Does Taj Pharma supply to hospitals?
Yes, directly and via distributors.
20. How to order from Taj Pharma?
Contact via email, phone, or the official website.






