GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sitagliptin Phosphate USP
equivalent to Sitagliptin 50mg
Excipients q.s.
Colour: Yellow Oxide of iron USNF and Titanium Dioxide USP.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Warning: Never share your medicines will others and use this medication only for the indication prescribed.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Sitagliptin Tablets USP 50mg Technical Specification:
| Product Name: | Sitagliptin Tablets USP 50mg |
| Brand Name: | (Sitafos) |
| Strength: | 50mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Mechanism |
| Indication: | Sitagliptin is used in the treatment of type 2 diabetes mellitus. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. |
| Storage: | Store below 30°C , store Protected from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Sitagliptin Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablets contains:
Sitagliptin Phosphate USP
equivalent to Sitagliptin 50mg
Excipients q.s.
Colour: Yellow Oxide of iron USNF and Titanium Dioxide USP.
THERAPEUTIC INDICATIONS:
to improve glycemic control in adults with type 2 diabetes mellitus. As a DPP-4 inhibitor, it helps lower blood sugar levels by increasing insulin release and reducing glucagon, particularly after meals. It is typically prescribed alongside diet and exercise to manage hyperglycemia.
CAUTION & Warning:
CAUTION: Do not swallow whole or chew, take this medicine on an empty stomach., disperse tablet in water before consuming.
Warning: Never share your medicines will others and use this medication only for the indication prescribed.
STORAGE & DOSAGE:
Storage: Store below 30°C, store Protected from moisture.
Dosage: As directed by the Physician.
Sitagliptin Tablets 50mg Manufacturer in India
Introduction to Sitagliptin Tablets 50mg
Sitagliptin Tablets 50mg are widely prescribed oral anti-diabetic medicines used for the treatment of Type 2 diabetes mellitus. The medicine belongs to a class of drugs known as DPP-4 inhibitors (Dipeptidyl Peptidase-4 inhibitors) which help control blood sugar levels by increasing insulin release and reducing glucose production in the liver.
The global burden of diabetes continues to increase, making medications like Sitagliptin Tablets 50mg highly important in modern healthcare systems. These tablets help regulate blood glucose levels, particularly after meals, and are often recommended alongside lifestyle changes such as healthy diet and regular physical activity.
Taj Pharma, the well-known Sitagliptin Tablets 50mg manufacturer in India, gives assurance of high quality, purity, and regulatory compliance. The medicine Sitagliptin 50 mg works by increasing insulin production and reducing glucose production in the body, making it an effective treatment for people with Type 2 diabetes.
In addition, Sitagliptin is commonly prescribed for patients who may have renal impairment, where proper dose adjustment is required under medical supervision.
Leading Sitagliptin Tablets 50mg Manufacturer
Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter and Supplier of Sitagliptin Tablets 50mg from Vapi, Gujarat, India. The company has built a strong reputation for delivering high-quality pharmaceutical formulations to global healthcare markets.
Sitagliptin, commonly known internationally under the brand name Januvia, is a medication used to help control blood sugar levels in adults suffering from Type 2 diabetes. It is usually taken orally once daily, with the dosage determined by a healthcare professional depending on the patient’s kidney function and medical condition.
Taj Pharma is a leading Sitagliptin Tablets 50mg manufacturer from Mumbai and Vapi, Gujarat, supplying quality-assured formulations to hospitals, distributors, and pharmaceutical importers worldwide.
Medical Overview of Sitagliptin Tablets 50mg
Sitagliptin is a medicine used to treat Type 2 diabetes, a chronic condition in which the body either does not produce enough insulin or the insulin produced does not function properly.
When used correctly, Sitagliptin Tablets 50mg can help patients achieve better glycemic control and reduce the risk of long-term complications such as:
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Kidney damage (diabetic nephropathy)
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Vision loss or blindness
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Nerve damage (neuropathy)
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Heart disease and stroke
The medicine may be prescribed alone or in combination with other anti-diabetic drugs. It works best when combined with proper diet, exercise, and routine blood sugar monitoring.
Taking Sitagliptin Tablets 50mg with meals may reduce stomach discomfort and improve tolerance.
Safety and Serious Adverse Reactions
Like all medications, Sitagliptin can cause side effects in some patients. Serious adverse drug reactions are harmful, unintended, and potentially dangerous reactions that require immediate medical attention.
According to global drug regulatory authorities, serious reactions include:
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Life-threatening conditions
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Hospitalization
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Permanent disability
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Birth defects
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Severe allergic reactions
Healthcare providers carefully monitor patients to minimize risks and ensure safe treatment outcomes.
Manufacturer Supplier and Exporter in India
Taj Pharma is among the leading Sitagliptin Tablets 50mg manufacturer & supplier in India, offering high-quality formulations for domestic and international markets.
The company is widely known for:
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Sitagliptin Tablets 50mg PAN India Manufacturer
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Sitagliptin Tablets 50mg Manufacturer Supplier and PCD Pharma Franchise
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Sitagliptin Tablets 50mg Manufacturers PAN India Suppliers Exporters
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Sitagliptin Tablets 50mg Manufacturer from Mumbai
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Sitagliptin Tablets 50mg Manufacturer in Vapi, Gujarat
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Sitagliptin Tablets 50mg Best Price in Mumbai Maharashtra Taj Pharma
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Sitagliptin Tablets 50mg Manufacturers India & Pioneer Exporters
With strong distribution capabilities, Taj Pharma supplies Sitagliptin tablets across India, Asia, Africa, Europe, and Latin America.
Detailed Export Information for Importers & Buyers
International pharmaceutical distributors and importers require comprehensive regulatory documentation and supply reliability. Taj Pharma ensures complete export support for Sitagliptin Tablets 50mg export from India.
Regulatory Documentation Provided
Global buyers receive complete regulatory documentation including:
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Certificate of Pharmaceutical Product (COPP)
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Certificate of Analysis (COA)
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Free Sale Certificate (FSC)
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Stability data
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Product specifications
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Material Safety Data Sheet (MSDS)
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Batch manufacturing records
These documents help importers register products in their respective countries.
Custom Packaging and Labeling
Taj Pharma provides customized packaging solutions based on client requirements:
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Blister packaging (Alu-Alu / Alu-PVC)
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Bottle packaging
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Bulk packaging for institutional supply
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Private labeling for distributors
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Country-specific labeling compliance
This flexibility makes Taj Pharma a preferred Sitagliptin Tablets 50mg supplier for international markets.
Shelf Life, Storage and Dosage Form
Proper storage and shelf life are essential for pharmaceutical products.
Key details include:
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Dosage Form: Oral Tablet
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Strength: 50 mg
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Shelf Life: 24–36 months
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Storage: Store below 25°C, protect from moisture and light
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Packaging: Blister / Bottle
Export Certifications
Taj Pharma manufacturing facilities comply with international regulatory standards including:
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WHO-GMP Certification
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EU-GMP compliance
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ISO certification
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COPP availability
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CTD dossier support
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Product registration assistance
These certifications ensure global buyers receive internationally compliant pharmaceutical products.
Global Export Markets
Taj Pharma exports Sitagliptin Tablets 50mg to numerous countries worldwide.
Top 20 Countries Exporting:
Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia
Why Taj Pharma is the Most Trusted Sitagliptin Tablets 50mg Manufacturer
State-of-the-Art Manufacturing
Taj Pharma operates advanced pharmaceutical manufacturing facilities in Vapi, Gujarat, equipped with modern machinery and strict quality control systems.
The facilities follow:
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WHO-GMP standards
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Automated production lines
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Advanced quality testing laboratories
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Strict batch validation processes
This ensures consistent product quality for Sitagliptin Tablets 50mg manufacturers in India.
Affordable Pricing and Quality Assurance
One of the key reasons international buyers choose Taj Pharma is competitive pricing combined with premium quality.
Benefits include:
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Cost-effective manufacturing
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Bulk supply capacity
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Stable pricing
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High purity formulations
This makes Taj Pharma a preferred Sitagliptin Tablets 50mg manufacturer supplier and PCD pharma franchise provider.
Strong Global Supply Chain
Taj Pharma offers a reliable export network with:
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Fast international shipping
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Regulatory support for product registration
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Flexible order quantities
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Dedicated export management team
These services make Taj Pharma one of the best Sitagliptin Tablets 50mg manufacturers India suppliers exporters.
Technical Product Specification
| Parameter | Specification |
|---|---|
| Product Name | Sitagliptin Tablets |
| Strength | 50 mg |
| Dosage Form | Oral Tablet |
| Therapeutic Category | Anti-Diabetic |
| Mechanism | DPP-4 Inhibitor |
| Indication | Type 2 Diabetes Mellitus |
| Packaging | Blister / Bottle |
| Shelf Life | 24–36 Months |
| Storage | Store below 25°C |
| Manufacturer | Taj Pharma Ltd |
| Manufacturing Location | Vapi, Gujarat, India |
| Certifications | WHO-GMP, ISO, COPP |
| Export Markets | Global |
PCD Pharma Franchise and Distribution Opportunities
Taj Pharma offers Sitagliptin Tablets 50mg Manufacturer Supplier and PCD Pharma Franchise opportunities across India and international markets.
Distributors benefit from:
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Monopoly rights
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Marketing support
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Promotional materials
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Competitive pricing
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Reliable supply chain
Entrepreneurs seeking Sitagliptin Tablets 50mg PCD Pharma Franchise / Manufacturer and Supplier partnerships can collaborate with Taj Pharma for long-term business growth.
Call to Action
If you are a pharmaceutical importer, distributor, or healthcare supplier, Taj Pharma offers reliable supply of Sitagliptin Tablets 50mg Manufacturer & Supplier in India with global regulatory support.
Partnering with Taj Pharma ensures:
✔ High-quality WHO-GMP pharmaceutical products
✔ Competitive export pricing
✔ Reliable international logistics
✔ Regulatory documentation support
✔ Long-term business partnership
Contact Taj Pharma today to receive quotations, product dossiers, and export details for Sitagliptin Tablets 50mg.
Top 20 FAQs
1. What are Sitagliptin Tablets 50mg used for?
They are used to control blood sugar levels in adults with Type 2 diabetes.
2. How does Sitagliptin work?
It works by inhibiting the DPP-4 enzyme, increasing insulin production and reducing glucose production.
3. Who manufactures Sitagliptin Tablets 50mg in India?
Taj Pharma is a leading Sitagliptin Tablets 50mg manufacturer in India.
4. Can Sitagliptin be taken with other diabetes medicines?
Yes, doctors may prescribe it with other anti-diabetic medications.
5. Is Sitagliptin safe for long-term use?
When prescribed by a doctor, it is generally safe for long-term diabetes management.
6. What is the usual dosage?
Typically 50 mg once daily, depending on medical advice.
7. Can patients with kidney disease take Sitagliptin?
Yes, but dosage adjustment may be required.
8. What are common side effects?
Possible side effects include headache, nausea, or stomach discomfort.
9. Does Sitagliptin cause hypoglycemia?
It rarely causes hypoglycemia when used alone.
10. Is Sitagliptin suitable for Type 1 diabetes?
No, it is intended only for Type 2 diabetes.
11. What packaging options are available?
Blister packs, bottles, and customized packaging.
12. What certifications does Taj Pharma provide?
WHO-GMP, COPP, CTD dossier, and regulatory documents.
13. Can Taj Pharma export Sitagliptin globally?
Yes, Taj Pharma exports to more than 20 countries worldwide.
14. What is the shelf life of Sitagliptin tablets?
Usually 24 to 36 months.
15. Can Sitagliptin be taken with food?
Yes, it can be taken with or without food.
16. What is the storage requirement?
Store in a cool, dry place below 25°C.
17. Is private labeling available?
Yes, Taj Pharma offers custom branding and private labeling.
18. Do you support product registration?
Yes, full regulatory documentation is provided.
19. Is Taj Pharma a WHO-GMP manufacturer?
Yes, Taj Pharma operates WHO-GMP certified facilities.
20. How can distributors partner with Taj Pharma?
By contacting the company for export supply or PCD franchise opportunities.






