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 50mg 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 50mg
Sitagliptin Phosphate Tablet 50mg is an innovative oral antidiabetic medication belonging to the DPP-4 inhibitors class. It is widely prescribed for the management of type 2 diabetes mellitus, a condition where blood sugar levels remain elevated due to insulin resistance or reduced insulin production.
The medicine works by increasing insulin release after meals and lowering glucose production in the liver, helping patients achieve better glycemic control. Sitagliptin Phosphate is often prescribed when diet and exercise alone, or in combination with other medications, fail to maintain normal blood sugar levels.
Globally, the demand for Sitagliptin Phosphate Tablet 50mg is increasing due to the rising incidence of type 2 diabetes, especially in regions like Asia, Africa, and Latin America. As a result, international buyers, importers, and healthcare institutions look toward India’s pharmaceutical industry, where Taj Pharma has established itself as a trusted manufacturer, supplier, and exporter of Sitagliptin Phosphate Tablet 50mg.
In-depth Details for Importers, Exporters & Buyers
When sourcing Sitagliptin Phosphate Tablet 50mg from India, global buyers seek reliable manufacturers that provide compliance, regulatory support, and consistent supply. Taj Pharma fulfills these requirements with unmatched professionalism.
✅ Regulatory Documentation Provided
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WHO-GMP, EU-GMP-certified manufacturing.
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COPP (Certificate of Pharmaceutical Product) for product registrations.
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CTD/ACTD Dossiers for regulatory submissions.
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Stability data and bioequivalence studies on request.
✅ Custom Packaging & Labeling
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Blister packs, bottles, or bulk packaging options.
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Multilingual labeling to suit export market requirements.
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Private labeling/contract manufacturing services.
✅ Shelf-life, Storage & Dosage Form
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Shelf-life: 24–36 months under controlled conditions.
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Storage: Store below 30°C, away from direct sunlight and moisture.
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Dosage form: Oral film-coated tablets.
✅ Export Certifications
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WHO-GMP Certified
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EU-GMP Accredited
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ISO 9001:2015 Certified
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COPP & FSC available
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Regulatory dossier support in CTD/ACTD formats
✅ Target Countries & Export Markets
Taj Pharma exports Sitagliptin Phosphate Tablet 50mg to:
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Asia: Philippines, Myanmar, Vietnam, Sri Lanka
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Middle East: UAE, Iraq, Saudi Arabia, Oman
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Africa: Nigeria, Kenya, South Africa, Tanzania
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Europe & CIS: Russia, Ukraine, Georgia, Poland
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Latin America: Peru, Ecuador, Chile, Mexico
This robust distribution ensures that Taj Pharma is among the top exporters of Sitagliptin Phosphate Tablet 50mg from India.
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
Taj Pharma is recognized as the 1 Sitagliptin Phosphate Tablet 50mg Manufacturer in India because of its world-class manufacturing practices, affordability, and global trust.
1. State-of-the-Art Manufacturing
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WHO-GMP and EU-GMP-certified facilities in Vapi, Gujarat.
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Automated systems for consistency and precision.
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Robust in-house R&D and formulation expertise.
2. Affordable Pricing & Quality Assurance
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Competitive pricing against global brands like Januvia®.
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Stringent quality control (QA/QC) at every stage of production.
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Guaranteed compliance with international pharmacopoeia standards.
3. Global Presence & Supply Chain Support
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Distribution network in 100+ countries worldwide.
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Reliable supply chain with assured on-time delivery.
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Support for government tenders and private distributors.
4. Top 20 Countries Exporting Sitagliptin Phosphate Tablet 50mg
Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic
Technical Product Specification:
| Parameter | Specification |
|---|---|
| Brand Name | Taj Pharma Label / Buyer’s Private Label |
| API | Sitagliptin Phosphate |
| Strength | 50mg |
| Dosage Form | Film-coated oral tablet |
| Packaging Options | Blister packs / Bottles / Bulk |
| Shelf Life | 24–36 months |
| Storage Conditions | Store below 30°C, dry place |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP |
| Indication | Type 2 Diabetes Mellitus |
| Route of Administration | Oral |
If you are an importer, distributor, or PCD pharma franchise partner, Taj Pharma offers Sitagliptin Phosphate Tablet 50mg at globally competitive prices backed by WHO-GMP quality.
📩 Contact Taj Pharma Today:
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🌐 Website: www.tajpharma.com
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📧 Email: info@tajpharma.com
Partner with the most trusted Sitagliptin Phosphate Tablet 50mg Manufacturer Supplier in India for your export and distribution needs.
Top 20 FAQs
1. What is Sitagliptin Phosphate Tablet 50mg used for?
It is used to manage type 2 diabetes mellitus by lowering blood sugar levels.
2. Who manufactures Sitagliptin Phosphate Tablet 50mg in India?
Taj Pharma is a leading WHO-GMP-certified manufacturer in India.
3. Can Sitagliptin 50mg be used with Metformin?
Yes, it is often prescribed along with Metformin for better glycemic control.
4. What are the common side effects?
Headache, upper respiratory tract infections, and mild stomach upset.
5. Is Sitagliptin safe for long-term use?
Yes, under medical supervision it is safe for long-term diabetes management.
6. Can it cause low blood sugar?
On its own, rarely. But combined with insulin or sulfonylureas, hypoglycemia may occur.
7. Is Sitagliptin available for export from India?
Yes, Taj Pharma exports worldwide with COPP, Dossiers, and WHO-GMP support.
8. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO, COPP, FSC.
9. What is the recommended dosage?
50mg once daily, or as prescribed by a physician.
10. How should Sitagliptin be stored?
Store at room temperature, away from moisture and sunlight.
11. Can pregnant women use Sitagliptin?
Consult a doctor before use during pregnancy or breastfeeding.
12. How quickly does it work?
It starts working within hours but may take weeks for full effect.
13. What is the shelf life?
24–36 months.
14. Is Sitagliptin Phosphate Tablet 50mg available in private labeling?
Yes, Taj Pharma offers custom branding and packaging services.
15. Is generic Sitagliptin available from India?
Yes, Taj Pharma manufactures cost-effective generic versions.
16. Which countries import Sitagliptin from Taj Pharma?
Over 20 countries across Asia, Africa, Middle East, and Latin America.
17. What precautions should be taken?
Limit alcohol intake, monitor blood sugar, and follow a prescribed diet and exercise plan.
18. Does Taj Pharma provide dossiers for registration?
Yes, CTD/ACTD dossiers are provided for regulated and semi-regulated markets.
19. Is Sitagliptin Phosphate Tablet 50mg affordable from Taj Pharma?
Yes, Taj Pharma ensures best pricing with uncompromised quality.
20. How do I place a bulk order?
Contact Taj Pharma via website or email for bulk quotations and export support.






