GENERIC NAME OF THE MEDICINAL PRODUCT:
Sitagliptin Phosphate Tablet IP 50mg
Sitagliptin Phosphate Tablet IP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
Equivalent to Sitagliptin…………………... 25mg
Excipients……………………………………q.s.
Colurs: Iron oxide Yellow
b) Sitagliptin Phosphate Tablet IP 50mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
Equivalent to Sitagliptin…………………... 50mg
Excipients……………………………………q.s.
Colurs: Iron oxide Red
c) Sitagliptin Phosphate Tablet IP 100mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
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: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Sitagliptin Phosphate Tablet 25mg Technical Specification:
| Product Name: |
Sitagliptin Phosphate Tablet IP |
| 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) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| 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: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sitagliptin Phosphate Tablet IP 25mg
- Sitagliptin Phosphate Tablet IP 50mg
- Sitagliptin Phosphate Tablet IP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Sitagliptin Phosphate Tablet IP 25mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
Equivalent to Sitagliptin…………………… 25mg
Excipients……………………………………q.s.
Colurs: Iron oxide Yellow - b) Sitagliptin Phosphate Tablet IP 50mg
Each film coated tablet contains
Sitagliptin Phosphate Monohydrate IP
Equivalent to Sitagliptin…………………… 50mg
Excipients……………………………………q.s.
Colurs: Iron oxide Red - c) Sitagliptin Phosphate Tablet IP 100mg
Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
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: Not to be sold by retail without the prescription of a Registered Medical Prescriber
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 25mg
Sitagliptin Phosphate Tablet 25mg is a highly effective oral medication used for the management of type 2 diabetes mellitus. It belongs to the class of DPP-4 inhibitors and works by regulating insulin levels after meals and reducing glucose production in the liver. This dual-action mechanism helps patients achieve better glycemic control.
Globally, type 2 diabetes has emerged as one of the fastest-growing chronic conditions, with over 500 million people affected worldwide. The demand for reliable, safe, and cost-effective anti-diabetic drugs is at an all-time high. Importers and distributors are increasingly looking toward India—especially Taj Pharma, a pioneer in the pharmaceutical manufacturing industry—for high-quality medicines like Sitagliptin Phosphate Tablet 25mg.
Taj Pharma, a leading Sitagliptin Phosphate Tablet 25mg Manufacturer in India, ensures every batch is produced under WHO-GMP, EU-GMP, and ISO-certified facilities, meeting the highest global quality benchmarks.
Product Overview
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Brand Name: Sitagliptin Phosphate Tablet 25mg
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Dosage Form: Film-coated oral tablet
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Strength: 25mg
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Indication: Type 2 diabetes mellitus management
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Mode of Action: Inhibits the DPP-4 enzyme, improving insulin release and reducing hepatic glucose production.
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Administration: Once daily, with or without food, as prescribed by a physician.
Taj Pharma’s Sitagliptin 25mg provides consistent therapeutic results, enabling better compliance for long-term diabetes management.
Why Sitagliptin Phosphate Tablet 25mg is in Global Demand
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Rising Diabetes Prevalence: With diabetes cases soaring worldwide, anti-diabetic medicines like Sitagliptin are in constant demand.
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Cost-Effective Alternatives: India provides a more affordable manufacturing base compared to Europe and the US.
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Safe & Effective Therapy: Sitagliptin has fewer risks of hypoglycemia compared to older drugs like sulfonylureas.
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Improved Compliance: Once-daily dosing improves adherence among patients.
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma provides a full set of regulatory support to international buyers:
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Certificate of Pharmaceutical Product (COPP)
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Drug Master File (DMF)
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Common Technical Document (CTD) dossier
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Bioequivalence studies (when required)
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Free Sale Certificate
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Stability data
Custom Packaging & Labeling
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Primary Packaging: Blister packs / Alu-Alu packs
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Secondary Packaging: Customized cartons with multilingual labeling
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Export Labeling Compliance: As per target country requirements (FDA, EMA, TGA, etc.)
Shelf-life, Storage & Dosage Form
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Shelf Life: 24–36 months from manufacturing
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Storage Conditions: Store below 30°C, in a dry, cool place, away from sunlight
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Dosage Form: Oral, film-coated tablet for daily use
Export Certifications
Taj Pharma is a WHO-GMP, EU-GMP, ISO 9001:2015 certified manufacturer with approvals from several international drug regulatory authorities. Key certifications include:
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WHO-GMP
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EU-GMP
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COPP for export markets
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ISO & CE compliance
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Halal-certified production (for select regions)
Target Countries & Export Markets
Taj Pharma exports Sitagliptin Phosphate Tablet 25mg to over 40 countries across:
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Africa: Nigeria, Kenya, South Africa, Ghana, Tanzania
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Asia-Pacific: Vietnam, Philippines, Sri Lanka, Myanmar, Cambodia
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Middle East: UAE, Saudi Arabia, Oman, Qatar, Kuwait
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Europe & CIS: Ukraine, Belarus, Georgia, Russia
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Latin America: Peru, Ecuador, Chile, Bolivia
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
1. State-of-the-Art Manufacturing
Taj Pharma’s Vapi, Gujarat facility is equipped with cutting-edge technology, automated production lines, and stringent quality checks ensuring international-grade production standards.
2. Affordable Pricing & Quality Assurance
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Competitive pricing without compromising on quality
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Adherence to pharmacopeial standards: IP, BP, USP
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Batch-to-batch consistency and zero-defect approach
3. Global Presence & Supply Chain Support
Taj Pharma operates with robust logistics and supply chain systems, ensuring timely delivery across continents with temperature-controlled shipping solutions.
4. Top 20 Countries Exporting Sitagliptin Phosphate Tablet 25mg
Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Sitagliptin Phosphate Tablet 25mg |
| Strength | 25mg |
| Dosage Form | Oral film-coated tablet |
| Packaging | Blister / Alu-Alu / Custom export packs |
| Storage | Below 30°C, dry place |
| Shelf Life | 24–36 months |
| Certifications | WHO-GMP, EU-GMP, COPP, ISO |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
If you are an importer, distributor, or PCD franchise partner looking for a reliable Sitagliptin Phosphate Tablet 25mg Manufacturer in India, Taj Pharma is your trusted partner.
📞 Contact Taj Pharma today to discuss bulk supply, private labeling, or regulatory documentation support for your market.
🌐 Visit: www.tajpharma.com
📧 Email: export@tajpharma.com
Top 20 FAQs
Q1: What is Sitagliptin Phosphate Tablet 25mg used for?
A: It is prescribed for type 2 diabetes to regulate blood sugar levels.
Q2: Is Taj Pharma a WHO-GMP certified manufacturer?
A: Yes, Taj Pharma is WHO-GMP and EU-GMP approved.
Q3: Can Sitagliptin 25mg be used alone?
A: Yes, or in combination with other anti-diabetic drugs like metformin.
Q4: What is the shelf life of Sitagliptin 25mg tablets?
A: 24–36 months.
Q5: Where does Taj Pharma manufacture Sitagliptin tablets?
A: At its facility in Vapi, Gujarat, India.
Q6: Does Taj Pharma provide export documentation?
A: Yes, including COPP, CTD, DMF, and Free Sale Certificates.
Q7: Can importers get customized packaging?
A: Yes, Taj Pharma offers custom packaging and labeling solutions.
Q8: Is Sitagliptin 25mg safe for long-term use?
A: Yes, when taken under medical supervision.
Q9: What are common side effects?
A: Headache, sore throat, or mild cold symptoms.
Q10: Does Taj Pharma export to Africa?
A: Yes, to countries like Nigeria, Kenya, and South Africa.
Q11: Can distributors get PCD franchise opportunities?
A: Yes, Taj Pharma offers PCD franchise programs.
Q12: Does alcohol affect Sitagliptin’s efficacy?
A: Excess alcohol may increase hypoglycemia risk.
Q13: Can pregnant women take Sitagliptin 25mg?
A: Only under medical supervision.
Q14: Does Taj Pharma offer private labeling?
A: Yes, customized branding solutions are available.
Q15: What is Taj Pharma’s export reach?
A: Over 40 countries globally.
Q16: How should Sitagliptin be stored?
A: Below 30°C, away from moisture and sunlight.
Q17: Is Sitagliptin affordable from Taj Pharma?
A: Yes, with globally competitive pricing.
Q18: Can Taj Pharma handle bulk orders?
A: Yes, with scalable production capacity.
Q19: Does Taj Pharma follow pharmacopeial standards?
A: Yes, IP/BP/USP standards are strictly followed.
Q20: Why choose Taj Pharma for Sitagliptin 25mg?
A: Trusted quality, global presence, WHO-GMP certification, and competitive pricing.






