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.

Sitagliptin Phosphate Tablet 100mg 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 100mg

Sitagliptin Phosphate Tablet 100mg is an oral antidiabetic medication widely prescribed for the treatment of type 2 diabetes mellitus. It belongs to the class of DPP-4 inhibitors, which work by increasing insulin production and reducing glucose output from the liver. When combined with a healthy diet, regular exercise, and sometimes with other antidiabetic drugs, Sitagliptin effectively helps maintain blood glucose levels and prevents complications such as kidney damage, heart disease, and vision loss.

The growing global demand for Sitagliptin Phosphate Tablet 100mg reflects the rising prevalence of type 2 diabetes across Asia, Africa, Europe, and North America. With India being a pharmaceutical hub, international buyers seek reliable manufacturers who offer quality, affordability, and regulatory compliance. Taj Pharma, headquartered in Vapi, Gujarat, has established itself as a trusted Sitagliptin Phosphate Tablet 100mg Manufacturer, Supplier, and Exporter in India.


In-depth Details for Importers, Exporters & Buyers

When sourcing Sitagliptin Phosphate Tablet 100mg from India, global buyers look for compliance, reliability, and supply consistency. Taj Pharma meets every requirement through:

✅ Regulatory Documentation Provided

  • WHO-GMP, EU-GMP, and USFDA-compliant manufacturing.

  • COPP (Certificate of Pharmaceutical Product) for international registrations.

  • CTD/ACTD Dossier support for product registration in regulated and semi-regulated markets.

  • Stability data and validation reports.

✅ Custom Packaging & Labeling

  • Blister packs, bottles, and bulk packaging as per buyer specifications.

  • Multilingual labeling for specific export markets.

  • Tamper-proof and export-friendly packaging.

✅ Shelf-life, Storage & Dosage Form

  • Standard shelf-life of 24–36 months under recommended storage conditions.

  • Dosage form: Oral tablets.

  • Storage: Keep below 30°C, protected from moisture and direct sunlight.

✅ Export Certifications

  • WHO-GMP Certification

  • EU-GMP Accreditation

  • ISO 9001:2015

  • COPP & FSC for global tenders

  • CTD/ACTD Dossiers

✅ Target Countries & Export Markets

Taj Pharma exports Sitagliptin Phosphate Tablet 100mg to:

  • Middle East: UAE, Saudi Arabia, Oman, Iraq

  • Africa: Nigeria, Kenya, Tanzania, South Africa

  • Asia: Philippines, Vietnam, Myanmar, Sri Lanka

  • Europe & CIS: Russia, Ukraine, Georgia, Poland

  • Latin America: Peru, Chile, Ecuador, Mexico

This wide distribution network makes Taj Pharma a leading global exporter of Sitagliptin Phosphate Tablet 100mg from India.


Why is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma is widely recognized as the No.1 Sitagliptin Phosphate Tablet 100mg Manufacturer in India due to its focus on quality, compliance, and affordability.

1. State-of-the-Art Manufacturing

  • WHO-GMP-certified facilities in Vapi, Gujarat.

  • Automated production lines with stringent quality assurance systems.

  • In-house R&D and formulation expertise.

2. Affordable Pricing & Quality Assurance

  • Competitive pricing compared to global brands like Januvia®.

  • Rigorous QA/QC checks at every stage.

  • Consistent product quality, batch-to-batch.

3. Global Presence & Supply Chain Support

  • Strong distribution in 100+ countries.

  • Robust supply chain ensuring on-time delivery.

  • Strategic partnerships with importers, distributors, and PCD franchisees.

4. Top 20 Countries Taj Pharma Exports Sitagliptin Phosphate Tablet 100mg

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 100mg
Dosage Form Film-coated tablet
Packaging Options Blister packs / Bottles / Bulk
Shelf Life 24–36 months
Storage Conditions Store below 30°C, protected from moisture
Certifications WHO-GMP, EU-GMP, ISO, COPP
Indication Type 2 Diabetes Mellitus
Route of Administration Oral

If you are an importer, distributor, PCD franchise owner, or government tender participant, Taj Pharma offers Sitagliptin Phosphate Tablet 100mg with unmatched quality and affordability.

📩 Contact Taj Pharma Today:

Make Taj Pharma your trusted partner for Sitagliptin Phosphate Tablet 100mg exports from India.


Top 20 FAQs

1. What is Sitagliptin Phosphate Tablet 100mg used for?
It is used to manage type 2 diabetes mellitus by regulating blood sugar levels.

2. Who manufactures Sitagliptin Phosphate Tablet 100mg in India?
Taj Pharma is a leading WHO-GMP certified manufacturer in India.

3. Is Sitagliptin Phosphate safe for long-term use?
Yes, under a doctor’s supervision, it is safe for long-term diabetes management.

4. Can Sitagliptin be taken with metformin?
Yes, it is often prescribed in combination with Metformin for better results.

5. What are the common side effects?
Headache, sore throat, cough, and mild gastrointestinal issues.

6. Does Sitagliptin cause low blood sugar?
On its own, it rarely causes hypoglycemia, but risk increases when used with insulin or sulfonylureas.

7. Is Sitagliptin Phosphate Tablet 100mg available for export?
Yes, Taj Pharma exports globally with COPP, Dossier, and WHO-GMP support.

8. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO, COPP, FSC, and Dossier support.

9. Is Sitagliptin better than glimepiride?
It is more weight-neutral and has fewer risks of hypoglycemia compared to sulfonylureas like glimepiride.

10. How should Sitagliptin be stored?
Keep below 30°C, away from moisture.

11. Can pregnant women take Sitagliptin?
Consult a doctor before use during pregnancy or breastfeeding.

12. How soon does Sitagliptin start working?
It begins lowering blood sugar within a few hours but full benefits show in weeks.

13. What is the shelf life?
24–36 months under recommended storage.

14. Is generic Sitagliptin available from India?
Yes, Taj Pharma manufactures generic Sitagliptin 100mg tablets.

15. Can I get Sitagliptin with private labeling?
Yes, Taj Pharma offers custom branding and packaging.

16. What is the recommended dosage?
100mg once daily, or as prescribed by a physician.

17. Which countries import Sitagliptin from Taj Pharma?
Over 20 countries including Nigeria, UAE, Vietnam, and Russia.

18. Does Taj Pharma provide dossiers for regulatory approval?
Yes, CTD/ACTD dossiers are available for all export markets.

19. Is Sitagliptin Phosphate Tablet 100mg affordable from Taj Pharma?
Yes, Taj Pharma offers best-in-class pricing without compromising quality.

20. How do I place a bulk order?
Contact Taj Pharma via email or website to request quotations and regulatory support.