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 25mg 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 25mg
Sitagliptin Phosphate Tablet 25mg is a highly effective oral medication prescribed for managing type 2 diabetes mellitus in adults. It works by increasing the levels of incretin hormones, which help the body release insulin and reduce the amount of glucose produced by the liver. This helps achieve better glycemic control when used alongside diet and exercise, and sometimes in combination with other anti-diabetic medications.
Globally, the demand for Sitagliptin Phosphate is on the rise due to the increasing prevalence of type 2 diabetes, particularly in Asia, Africa, Europe, and Latin America. Countries with growing middle-class populations are actively importing this medicine to meet the therapeutic needs of patients.
Taj Pharma, the leading Sitagliptin Phosphate Tablet 25mg manufacturer in India, has been meeting this global demand with exceptional quality, regulatory compliance, and reliable supply chains.
In-Depth Details for Importers, Exporters & Buyers
If you are a pharmaceutical importer, distributor, or PCD pharma franchise partner, Taj Pharma offers unmatched advantages in terms of regulatory support, packaging customization, and export compliance.
1. Regulatory Documentation Provided
Taj Pharma supplies all essential documents for smooth international trade, including:
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Certificate of Pharmaceutical Product (COPP)
-
WHO-GMP & EU-GMP Compliance Certificates
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CTD / ACTD Dossier for regulatory submissions
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Certificate of Analysis (COA)
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Free Sale Certificate
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Stability Data
2. Custom Packaging & Labeling
We understand diverse market regulations and branding needs. Taj Pharma offers:
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Multi-lingual labels
-
Country-specific compliance packaging
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Custom branding for private labeling
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Blister and bottle packaging options
3. Shelf-Life, Storage, Dosage Form
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Shelf-life: 24–36 months
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Storage: Store below 30°C, in a cool, dry place away from direct sunlight
-
Dosage Form: Film-coated tablets (25mg)
4. Export Certifications
Taj Pharma’s manufacturing facility is certified by:
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WHO-GMP (World Health Organization – Good Manufacturing Practice)
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EU-GMP (European Union – Good Manufacturing Practice)
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ISO 9001:2015 Quality Certification
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Compliance with ICH stability guidelines
5. Target Countries & Export Markets
Our export network spans 70+ countries, including:
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Asia: Vietnam, Philippines, Bangladesh, Sri Lanka
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Africa: Nigeria, Kenya, Ghana, South Africa
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Middle East: UAE, Saudi Arabia, Oman, Qatar
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Europe & Latin America: UK, Germany, Chile, Peru
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
Taj Pharma’s reputation as a top Sitagliptin Phosphate Tablet 25mg manufacturer in India is built on four core pillars:
1. State-of-the-Art Manufacturing
Our WHO-GMP certified facility in Vapi, Gujarat uses advanced technology, automated processes, and stringent in-process quality checks.
2. Affordable Pricing with Quality Assurance
We balance competitive pricing with uncompromised product quality, making us the preferred partner for importers in cost-sensitive markets.
3. Global Presence & Supply Chain Support
Our strong logistics network ensures timely deliveries to over 70 countries, meeting urgent bulk orders and tender requirements.
4. Top 20 Export Destinations
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 |
|---|---|
| Brand Name | Taj Sitagliptin 25 |
| Generic Name | Sitagliptin Phosphate |
| Strength | 25mg |
| Dosage Form | Film-coated Tablet |
| Indication | Type 2 Diabetes Mellitus |
| Packaging | 10 tablets/blister, 10 blisters/box or custom |
| Shelf Life | 24–36 months |
| Storage Conditions | Below 30°C, dry place |
| Certifications | WHO-GMP, EU-GMP, ISO 9001:2015 |
| Origin | India |
| Manufacturer | Taj Pharma Ltd., Vapi, Gujarat, India |
If you are an importer, distributor, or PCD franchise partner seeking a reliable Sitagliptin Phosphate Tablet 25mg manufacturer in India, Taj Pharma is your trusted global partner.
📞 Contact Now: sales@tajpharma.com | 🌐 www.tajpharma.com
Top 20 FAQs
1. What is Sitagliptin Phosphate Tablet 25mg used for?
It’s used to manage type 2 diabetes by controlling blood sugar levels.
2. How should I take Sitagliptin?
Take it orally once daily, with or without food, at the same time each day.
3. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma holds WHO-GMP, EU-GMP, and ISO certifications.
4. Can it be taken with other anti-diabetic drugs?
Yes, under medical supervision, it can be combined with metformin or insulin.
5. What’s the shelf life?
Typically 24–36 months from manufacturing date.
6. Does it cause weight change?
Sitagliptin generally does not cause significant weight gain or loss.
7. Is it available for PCD franchise?
Yes, Taj Pharma offers PCD pharma franchise opportunities.
8. Which countries does Taj Pharma export to?
We export to 70+ countries across Asia, Africa, Middle East, Europe, and Latin America.
9. Do you offer custom branding?
Yes, we provide private labeling and country-specific packaging.
10. Are bulk orders possible?
Yes, bulk and tender supplies are available.
11. Is regulatory documentation provided?
Yes, COPP, COA, and CTD dossiers are supplied.
12. Can Sitagliptin be stopped suddenly?
Stopping without doctor’s advice may worsen blood sugar control.
13. Is it available in Mumbai?
Yes, available PAN India including Mumbai, Maharashtra.
14. What is the dosage strength?
Each tablet contains 25mg Sitagliptin Phosphate.
15. How is it stored?
Store in a cool, dry place below 30°C.
16. Is it suitable for type 1 diabetes?
No, it is indicated only for type 2 diabetes.
17. Are there any serious side effects?
Rare but possible—heart failure, allergic reactions, swelling.
18. Is it safe during pregnancy?
Use only if prescribed by a doctor.
19. Does Taj Pharma provide shipping support?
Yes, we manage documentation and logistics.
20. How can I place an order?
Email our sales team or visit our official website.






