Description

Metformin Hydrochloride Tablets (500mg / 850mg / 1000mg)

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 large-scale Manufacturer of Metformin Hydrochloride Tablets in India. Metformin is the global “Gold Standard” First-Line Therapy for the management of Type 2 Diabetes Mellitus. It belongs to the Biguanide class and is the most widely prescribed anti-diabetic drug in the world due to its efficacy, safety profile, and lack of weight gain.

We offer Contract Manufacturing (Third Party) services for both Immediate Release (IR) and Sustained Release (SR/XR) formulations. Metformin is a high-volume product that presents specific manufacturing challenges, including a distinct “fishy” odor and poor flow properties. Our WHO-GMP certified facility in Mumbai utilizes advanced Wet Granulation and Odor-Masking Film Coating technologies to produce high-quality, patient-friendly tablets. Healthy Inc manages the export logistics, supplying government tenders, hospital chains, and pharmacies across the USA, Europe, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Handling high-volume bulk production with precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Sustained Release (SR) Matrix: Metformin IR often causes stomach upset. We manufacture SR Tablets using a hydrophilic matrix system (HPMC). This allows the drug to release slowly over 10-12 hours, significantly reducing gastrointestinal side effects (diarrhea/nausea) and allowing for once-daily dosing.

  • Odor Masking: Metformin API naturally smells like amines (fishy). We use a specialized flavor-infused Film Coating to completely seal the core, ensuring the patient does not experience this unpleasant odor when opening the blister or bottle.

  • NDMA Free: We rigorously screen our API sources and finished products to ensure they are free from Nitrosamine (NDMA) impurities, adhering to the latest FDA and EMA safety alerts.

• The Exporter: Healthy Inc

  • Bulk Logistics: As a high-volume drug, shipping efficiency is key. We optimize packaging configurations (high-density bulk jars or compact blisters) to maximize container loads and reduce freight costs for our partners.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • IR: >80% release in 30 minutes.

  • SR: Controlled release profile tested at 1hr, 4hr, and 10hrs.

• Assay: We confirm the potency is strictly within 95-105% of the label claim.

• Impurity Profiling: Strict control of related substances and heavy metals.

5. Why Use Metformin?

It attacks diabetes from multiple angles.

• Mechanism:

  1. Liver: Reduces hepatic glucose production (gluconeogenesis).

  2. Muscle: Increases insulin sensitivity, helping muscles use glucose for energy.

  3. Gut: Delays intestinal absorption of glucose.

• Key Indications:

  • Type 2 Diabetes: First-line treatment (monotherapy or combination).

  • Pre-Diabetes: Prevention of diabetes in high-risk individuals.

  • PCOS (Polycystic Ovary Syndrome): (Off-label) Used to improve insulin resistance and induce ovulation.

  • Gestational Diabetes: Used in pregnancy when insulin is not an option (under strict supervision).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) 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 Metformin Tablets?

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

• Q: Does it cause low blood sugar (Hypoglycemia)?

  A: Rarely. Unlike sulfonylureas (e.g., Glimepiride), Metformin does not stimulate insulin secretion, so it rarely causes dangerous drops in blood sugar when used alone.

• Q: Does it cause weight loss?

  A: Yes. Many patients experience modest weight loss due to reduced appetite, making it ideal for overweight diabetic patients.

• Q: Why does it give me diarrhea?

  A: This is the most common side effect. It usually goes away after a few weeks. Taking the SR (Sustained Release) version with dinner helps minimize this.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 500mg once or twice daily with meals.

• Maintenance Dose: 850mg or 1000mg twice daily. (Max 2550mg/day).

• Administration: Must be taken with meals to reduce stomach upset. Swallow SR tablets whole; do not crush.

9. Side Effects and Precautions

• Gastrointestinal: Diarrhea, nausea, bloating (Very common).

• Lactic Acidosis: Black Box Warning: Rare but serious accumulation of acid in the blood. Risk increases in patients with kidney failure, liver disease, or excessive alcohol use.

• B12 Deficiency: Long-term use can reduce Vitamin B12 absorption. Periodic monitoring is recommended.

• Kidney Function: Contraindicated in severe renal impairment (eGFR < 30 mL/min).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.