Sitagliptin Phosphate Tablet 100mg

Sitagliptin Phosphate Tablet  100mg Technical Specification:

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 100mg

Sitagliptin Phosphate Tablet 100mg is a highly effective oral medication used to control blood sugar levels in adults with Type 2 Diabetes Mellitus. It works by increasing insulin release and decreasing glucose production in the liver, helping patients maintain optimal glycemic control when combined with proper diet and exercise.

Globally, the demand for Sitagliptin Phosphate Tablet 100mg is on the rise due to the increasing prevalence of type 2 diabetes, especially in regions like Asia-Pacific, Middle East, Africa, and Latin America. As one of the safest and most convenient anti-diabetic medicines, it is preferred by healthcare providers and patients alike.

Taj Pharma is a WHO-GMP certified, top-rated Sitagliptin Phosphate Tablet 100mg manufacturer in India, delivering premium quality products that meet both domestic and international quality standards. With a commitment to purity, efficacy, and affordability, Taj Pharma ensures that its Sitagliptin tablets are widely accessible to patients across the globe.

Details for Importers, Exporters, and Buyers

Taj Pharma offers end-to-end export solutions for Sitagliptin Phosphate Tablet 100mg, ensuring smooth international trade for partners.

Regulatory Documentation Provided

• WHO-GMP Certificate

• EU-GMP Certification (where applicable)

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• Certificate of Analysis (COA)

• Batch Manufacturing Record (BMR)

• Stability Data (Accelerated & Real Time)

• Common Technical Document (CTD) Dossier

Custom Packaging & Labeling

Taj Pharma provides customized export packaging to meet country-specific regulatory and branding requirements, including:

• Blister packs, strip packs, or bulk packaging

• Tamper-proof sealing

• Multilingual labeling as per importing country norms

• Private label / Contract manufacturing options

Shelf-life, Storage, Dosage Form

• Dosage Form: Film-coated oral tablet

• Strength: Sitagliptin Phosphate 100mg

• Shelf-life: 24–36 months (depending on stability data)

• Storage: Store in a cool, dry place below 25°C, protected from light and moisture

Export Certifications

Taj Pharma complies with stringent manufacturing standards and holds the following certifications:

• WHO-GMP (World Health Organization – Good Manufacturing Practices)

• EU-GMP (European Union – Good Manufacturing Practices)

• ISO 9001:2015 Certified

• COA & COPP for each batch exported

• Regulatory dossiers in CTD/eCTD formats

Target Countries & Export Markets

Taj Pharma exports Sitagliptin Phosphate Tablet 100mg to:

• Middle East (UAE, Saudi Arabia, Oman)

• Africa (Nigeria, Kenya, South Africa, Egypt)

• Asia (Philippines, Vietnam, Sri Lanka, Bangladesh)

• CIS Countries (Kazakhstan, Uzbekistan, Russia)

• Latin America (Peru, Chile, Ecuador)

• Europe (Poland, Romania, Bulgaria)

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

Taj Pharma operates ultra-modern manufacturing plants in Vapi, Gujarat, equipped with the latest automated machinery and controlled environments to maintain consistency in every production batch.

2. Affordable Pricing with Uncompromised Quality

Being a high-volume manufacturer, Taj Pharma offers competitive pricing while maintaining stringent quality control measures to ensure each tablet meets pharmacopeial standards (IP, BP, USP).

3. Global Presence & Supply Chain Support

Taj Pharma has a strong international supply chain with reliable shipping partners ensuring on-time delivery of Sitagliptin Phosphate Tablet 100mg worldwide.

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 Table

If you are an importer, distributor, or PCD franchise partner looking for a reliable Sitagliptin Phosphate Tablet 100mg manufacturer in India, Taj Pharma offers the best combination of quality, pricing, and regulatory support.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

Top 20 FAQs 

1. What is Sitagliptin Phosphate Tablet 100mg used for?
It is used to control blood sugar levels in adults with Type 2 Diabetes.

2. How should I take Sitagliptin 100mg?
Once daily, with or without food, preferably at the same time each day.

3. Can I take Sitagliptin with other anti-diabetic medicines?
Yes, under doctor’s supervision; it is often combined with metformin.

4. Is Sitagliptin safe for patients with kidney problems?
Yes, but dose adjustment may be required.

5. What are the common side effects?
Headaches, sore throat, and upper respiratory infections.

6. Is Sitagliptin addictive?
No, it is non-habit forming.

7. Can pregnant women take Sitagliptin?
Only if prescribed by a doctor after risk assessment.

8. Can Sitagliptin cause hypoglycemia?
Rarely, unless combined with sulfonylureas or insulin.

9. What should I do if I miss a dose?
Take it as soon as you remember, unless it’s almost time for your next dose.

10. Can I consume alcohol while taking Sitagliptin?
Alcohol should be limited as it may affect blood sugar control.

11. Does Sitagliptin interact with other medicines?
Yes, always inform your doctor about all medicines you are taking.

12. How long does Sitagliptin take to work?
It starts working within a few hours but full benefits may take weeks.

13. Is it available in combination form?
Yes, often with metformin.

14. Can Sitagliptin be taken without food?
Yes, it can be taken with or without meals.

15. What is the shelf-life of Sitagliptin 100mg tablets?
24–36 months depending on packaging.

16. Does Taj Pharma provide Sitagliptin for export only?
No, it is available for both domestic and export markets.

17. Is Sitagliptin covered by WHO-GMP certification at Taj Pharma?
Yes, Taj Pharma is WHO-GMP certified.

18. Can I get private label manufacturing for Sitagliptin?
Yes, Taj Pharma offers contract manufacturing and private labeling.

19. Does Taj Pharma support regulatory filings?
Yes, complete CTD/eCTD dossiers are provided.

20. What is the minimum order quantity for export?
Varies by market; contact Taj Pharma for details.