Dapagliflozin Tablet Technical Specification – Taj Pharmaceuticals

Overview of Dapagliflozin Tablet

Dapagliflozin Tablet is an innovative oral antidiabetic medication developed to improve glycemic control in adults with Type 2 Diabetes Mellitus. Manufactured and supplied by Taj Pharmaceuticals, a globally recognized pharmaceutical company, this product exemplifies precision, safety, and therapeutic efficacy. Dapagliflozin works as a Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitor, promoting glucose excretion through urine and thereby lowering blood sugar levels effectively.

With WHO-GMP-certified manufacturing facilities in Mumbai and Vapi, Taj Pharma ensures every batch of Dapagliflozin tablets meets the highest international standards for quality, purity, and performance.

Product Technical Specification

Product Name:

Dapagliflozin Tablet

Brand Name:

Generics / Taj Pharma Brand / Private Label Options Available

Strength:

5mg and 10mg

Dosage Form:

Film-Coated Tablets

Route of Administration:

Oral

Packing:

30’s, 90’s, 100’s tablets per pack (Alu-Alu / Blister), 100’s tablets per Bottle

Regulatory Documentation:

COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier

Therapeutic Use:

Antidiabetic

Indication:

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus and provide adequate long-term glucose management.

Storage Conditions:

Store below 25°C, protect from moisture.
Do not freeze. Keep the container tightly closed.

Composition of Dapagliflozin Tablets

Dapagliflozin Tablet 5mg:

• Active Ingredient: Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin 5mg
• Excipients: q.s.
• Color: Iron Oxide Yellow Ph. Eur.

Dapagliflozin Tablet 10mg:

• Active Ingredient: Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin 10mg
• Excipients: q.s.
• Color: Quinoline Yellow

Therapeutic Indications

Dapagliflozin Tablets are used:

• As monotherapy or in combination with other antidiabetic agents.
• To improve glycemic control in adults with Type 2 Diabetes Mellitus.
• To reduce cardiovascular risk in diabetic patients with existing heart conditions.
• As a supportive therapy in managing Chronic Kidney Disease (CKD).

Its mechanism enhances renal glucose excretion, reducing blood sugar without stimulating insulin secretion — offering a safe alternative for long-term diabetes management.

Pharmacological Action

Dapagliflozin belongs to the class of SGLT2 inhibitors. It acts by inhibiting glucose reabsorption in the proximal renal tubules, allowing excess glucose to be excreted through urine. This mechanism:

• Decreases plasma glucose concentration.
• Promotes weight loss due to calorie loss in urine.
• Reduces blood pressure mildly due to osmotic diuresis.

Clinical studies confirm its efficacy in lowering HbA1c levels and improving overall metabolic parameters.

Dosage and Administration

• Dosage: As prescribed by the physician.
• Typical Dose: One tablet (10mg) orally once daily, with or without food.
• Special Instructions: Swallow whole; do not crush or chew.
• Caution: Ensure adequate hydration to avoid hypotension or dehydration.

Caution and Warning

Caution:

• Read the enclosed leaflet carefully before use.
• Keep out of reach of children.
• Not recommended in patients with Type 1 Diabetes or diabetic ketoacidosis.

Warning:

• Sale and use only on the prescription of a Registered Medical Practitioner.
• Report any signs of urinary tract infection or dehydration promptly.

Storage Instructions

• Protect from moisture at a temperature not exceeding 25°C.
• Do not freeze.
• Keep tightly closed to maintain tablet integrity and potency.

Dapagliflozin 10mg Tablets Manufacturer & Supplier in India

Taj Pharmaceuticals stands as a leading Dapagliflozin 10mg Tablets Manufacturer and Supplier in India, serving across Mumbai, Maharashtra, Gujarat, and PAN India. With WHO-GMP-certified facilities, Taj Pharma ensures consistent quality through advanced manufacturing systems, automated production lines, and rigorous in-house quality testing.

Our manufacturing excellence supports:

• PCD Pharma Franchise Programs
• Third-party / Contract manufacturing
• Bulk exports and supply to global distributors

Why Choose Taj Pharmaceuticals for Dapagliflozin Manufacturing

Taj Pharma offers unmatched reliability and quality in Dapagliflozin production. Our commitment includes:

• WHO-GMP / GLP / ISO 9001:2015 certified facilities
• DCGI-approved formulations
• Experienced QA/QC teams ensuring batch-wise consistency
• Comprehensive regulatory documentation (COA, COPP, FSC, CTD)
• Private labeling and multilingual packaging options
• Affordable pricing with flexible MOQ for partners

We specialize in customized blister and Alu-Alu packs, ensuring compliance with client-specific regulatory needs for both domestic and export markets.

PAN India Supply & Global Export

Our extensive distribution network covers:

• Maharashtra, Gujarat, Delhi NCR, Rajasthan, Tamil Nadu, Kerala, Punjab, West Bengal, and Karnataka.
  Taj Pharma’s rapid logistics and supply chain ensure on-time delivery of bulk consignments across India.

Export Markets Include:

• Africa: Nigeria, Kenya, Uganda
• Asia: Vietnam, Philippines, Sri Lanka
• CIS & Europe: Ukraine, Uzbekistan
• Latin America: Peru, Chile

We assist international clients with registration dossiers, COA, COPP, MSDS, stability data, and full export documentation to ensure seamless market entry.

Third-Party Manufacturing and PCD Franchise Opportunities

Taj Pharmaceuticals offers comprehensive third-party manufacturing and PCD Pharma franchise opportunities for Dapagliflozin Tablets.

Third-Party Manufacturing Benefits:

• Custom formulations and branding
• Flexible MOQs
• Confidentiality assurance
• Timely delivery and quality consistency

PCD Franchise Benefits:

• Monopoly distribution rights
• Promotional and marketing support
• High profit margins
• Zero stock-out guarantee

We empower our franchise partners through continuous supply, affordable pricing, and 100% marketing support.

Quality Assurance and Regulatory Compliance

At Taj Pharma, quality assurance is central to every production phase:

• Raw material testing
• In-process checks during granulation and compression
• Analytical method validation
• Stability studies to ensure long-term shelf life

All products comply with IP/BP/USP specifications, ensuring purity, potency, and bioavailability in every batch.

Dapagliflozin 10mg Tablets – Product Specifications

How to Order Dapagliflozin Tablets

To place a bulk order, partner for PCD franchise, or inquire about contract manufacturing, contact:

📞 Phone: +91-22-2637-4592
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

Our sales experts provide prompt quotations, samples, and full regulatory support for both domestic and international clients.

Dapagliflozin Tablet by Taj Pharmaceuticals stands as a testament to pharmaceutical excellence, combining innovation, compliance, and affordability. Whether you seek bulk supply, franchise opportunities, or third-party manufacturing, Taj Pharma ensures a trusted partnership, unmatched quality, and global-standard formulations for diabetes care.