Description

Sitagliptin Tablets (25mg – 100mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Sitagliptin Tablets in India. Sitagliptin is a leading Dipeptidyl Peptidase-4 (DPP-4) Inhibitor, a class of oral anti-diabetic medications used to manage blood sugar levels in patients with Type 2 Diabetes Mellitus. Unlike older diabetes drugs, Sitagliptin works only when blood sugar is high, significantly reducing the risk of hypoglycemia (low blood sugar).

We offer Contract Manufacturing (Third Party) services for this high-value generic formulation. Sitagliptin is known for being “weight neutral” (does not cause weight gain), making it a preferred choice for modern diabetes management. Our WHO-GMP certified facility in Mumbai utilizes advanced direct compression or wet granulation technologies to ensure the chemical stability of the active ingredient. Healthy Inc manages the export logistics, supplying pharmacy chains and diabetic care centers across the Middle East, Southeast Asia, Africa, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Producing a stable DPP-4 inhibitor requires precise environmental control.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Protection: Sitagliptin Phosphate Monohydrate can be sensitive to moisture-induced degradation. We manufacture in Dehumidified Suites (< 40% RH) to ensure stability during the compression process.

  • Granulation: We optimize the particle size distribution to ensure the tablet has a smooth surface and high hardness, preventing capping or lamination during packaging.

  • Coating: We use a specialized Opadry Film Coating that protects the core from environmental humidity and gives the tablet a distinct, professional finish identifying the strength.

• The Exporter: Healthy Inc

  • Packaging: We typically use Alu-Alu Cold Form Blisters or high-barrier PVDC Blisters to ensure the product remains stable in tropical export climates, maintaining its efficacy throughout the shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We use HPLC methods to strictly control the potency (90-110%) of Sitagliptin.

• Dissolution: We test release profiles to ensure >85% of the drug releases within 30 minutes, ensuring rapid absorption after meals.

• Related Substances: We strictly monitor for degradation products and process impurities to ensure the safety of this chronic medication.

5. Why Use Sitagliptin?

It provides “Smart” blood sugar control.

• Mechanism: It inhibits the DPP-4 enzyme, which normally breaks down incretin hormones (GLP-1 and GIP). By blocking this breakdown, Sitagliptin increases the levels of active incretins. This signals the pancreas to release more insulin and the liver to stop making sugar—but only when blood sugar is high.

• Key Indications:

  • Type 2 Diabetes: Monotherapy or in combination with Metformin, Sulfonylureas, or Insulin.

• Advantages:

  • No Hypoglycemia: Low risk of dangerous blood sugar drops compared to Glimepiride.

  • Weight Neutral: Does not cause weight gain.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sitagliptin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is this the same as Januvia?

  A: Yes, Sitagliptin Phosphate is the generic equivalent of Januvia.

• Q: Can I take it with Metformin?

  A: Yes. In fact, it is very commonly prescribed together with Metformin (often as a single combination pill) because they work in complementary ways to lower blood sugar.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 100mg once daily.

• Renal Adjustment:

  • GFR 30-45 mL/min: Dose reduced to 50mg daily.

  • GFR < 30 mL/min: Dose reduced to 25mg daily.

• Administration: Swallow whole. Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Nasopharyngitis (stuffy nose/sore throat), headache, and upper respiratory tract infection.

• Pancreatitis: Rare post-marketing reports of acute pancreatitis. Patients should stop if they experience severe, persistent abdominal pain.

• Joint Pain: Severe joint pain has been reported in some patients (resolves upon discontinuation).

• Heart Failure: Use with caution in patients with a history of heart failure.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from moisture.