Description

Pioglitazone Tablets (15mg – 45mg)

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 Pioglitazone Tablets in India. Pioglitazone is a Thiazolidinedione (TZD) anti-diabetic medication that works as an “Insulin Sensitizer.” Unlike other diabetes drugs that increase insulin production, Pioglitazone helps the body use its existing insulin more effectively by targeting insulin resistance in muscle and fat cells.

We offer Contract Manufacturing (Third Party) services for this essential Type 2 Diabetes treatment. Our WHO-GMP certified facility in Mumbai utilizes high-precision manufacturing processes to ensure content uniformity across all dosage strengths. Healthy Inc manages the export logistics, supplying pharmacy chains and diabetic care centers across the Middle East, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Targeting insulin resistance requires precise formulation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: We use advanced High-Shear Granulation and Geometric Mixing to ensure that the active ingredient (Pioglitazone Hydrochloride) is perfectly distributed throughout the tablet batch, ensuring consistent dosage in every pill.

  • Dissolution Enhancement: Pioglitazone is practically insoluble in water. We use specific disintegrants and binders to ensure the tablet breaks down rapidly in the stomach, maximizing bioavailability.

  • Stability: We control humidity levels during manufacturing to prevent hydrolysis and ensure the stability of the hydrochloride salt.

• The Exporter: Healthy Inc

  • Packaging: We offer Alu-Alu Blisters for markets with high humidity to provide superior moisture protection compared to standard PVC blisters.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We rigorously monitor for organic impurities to ensure long-term safety.

5. Why Use Pioglitazone?

It attacks the root cause of Type 2 Diabetes: Insulin Resistance.

• Mechanism: It acts as an agonist at PPAR-gamma receptors in the cell nucleus. This regulates genes involved in glucose and lipid metabolism, making cells more sensitive to insulin.

• Key Indications:

  • Type 2 Diabetes: Used as monotherapy or in combination with Metformin, Sulfonylureas, or Insulin to improve glycemic control.

  • Fatty Liver (NASH): (Off-label) Sometimes used to reduce liver fat and inflammation.

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 Pioglitazone Tablets?

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

• Q: Does it cause low blood sugar?

  A: Rarely on its own. Since it doesn’t increase insulin production, it carries a low risk of hypoglycemia unless combined with other drugs like Glimepiride or Insulin.

• Q: Can it cause weight gain?

  A: Yes. It promotes fluid retention (edema) and can increase subcutaneous fat, leading to weight gain.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 15mg or 30mg once daily.

• Max Dose: 45mg once daily.

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

9. Side Effects and Precautions

• Edema (Fluid Retention): Can worsen Heart Failure. Contraindicated in patients with NYHA Class III or IV Heart Failure.

• Bone Fractures: Increased risk of bone fractures in women.

• Bladder Cancer: Use with caution. Avoid in patients with active bladder cancer or a history of it (regulatory warnings vary by country).

• Liver: Rare hepatotoxicity. Monitor liver enzymes periodically.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture and light.