Metformin Capsule Manufacturer in India

WHO-GMP certified Metformin hard gelatin capsule manufacturing — 500mg and 850mg — for domestic institutional supply and international export.

Key Highlights

  • WHO-GMP
    Certified Facility

  • Hard Gelatin &
    HPMC Vegetarian Capsules

  • DCGI Approved
    Formulations

  • 15+ Countries
    Supplied

About

About Metformin Capsules — 9M India

9M India manufactures Metformin Hydrochloride hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Metformin is the most widely prescribed oral antidiabetic agent globally and the first-line pharmacological treatment for Type 2 diabetes mellitus in most international guidelines. Available in 500mg and 850mg strengths, our capsules conform to BP/USP pharmacopoeial standards with complete stability data and regulatory documentation for export.

Capsule formulation specifications

Specification Details
Molecule Metformin Hydrochloride
Dosage Form Hard Gelatin Capsule
Available Strengths 500mg, 850mg
Pharmacopoeial Standard BP / USP / IP
Therapeutic Class Antidiabetic — Biguanide
Pack Options 10 capsules per strip; bulk packs available
Storage Store below 30°C, protect from moisture
Shelf Life 24 months
MOQ As per enquiry — contact us

Therapeutic use & clinical indications

Metformin reduces hepatic glucose output by inhibiting gluconeogenesis, improves peripheral insulin sensitivity and reduces intestinal glucose absorption. Unlike sulphonylureas, it does not cause hypoglycaemia or weight gain. It is recommended as first-line therapy in Type 2 diabetes by WHO, ADA and most international guidelines.

Primary Indications:

  • Type 2 diabetes mellitus — first-line treatment
  • Polycystic ovary syndrome (PCOS) — insulin sensitisation
  • Prediabetes — prevention of progression
  • Combination antidiabetic therapy — with sulphonylureas, DPP-4 inhibitors, SGLT2 inhibitors

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    Export Markets & Regulatory

    Export markets & regulatory readiness

    9M India exports Metformin capsules to regulated and semi-regulated markets across the Middle East, CIS countries, Africa, ASEAN and Latin America. All formulations are manufactured under WHO-GMP conditions and supported by complete regulatory documentation including CTD/ACTD dossiers, Certificate of Pharmaceutical Product (CoPP), Free Sale Certificate (FSC), and Certificate of Analysis (CoA).

    • WHO-GMP Certificate

    • DCGI Manufacturing Licence

    • Certificate of Pharmaceutical Product (CoPP)

    • Certificate of Analysis (CoA) — batch-wise

    • CTD / ACTD Dossier — on request

    • Stability Data — ICH Zone IVb (30°C/75% RH)

    Partner with 9M India for Metformin capsule supply

    Whether you are a pharmaceutical distributor, institutional buyer, government procurement agency or export partner, 9M India is equipped to supply Metformin capsules at scale — with full regulatory support and flexible packaging options.

    • WHO-GMP
      Certified

    • Export
      Ready

    • 15+ Countries
      Supplied

    • DCGI
      Approved

    We keep answer short

    Frequently asked questions — Metformin capsules

    • 01

      Yes. 9M India manufactures Metformin Hydrochloride hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Available in 500mg and 850mg strengths, the formulation is DCGI approved and exported to markets across the Middle East, Africa, CIS and ASEAN.

    • 02

      9M India manufactures Metformin Hydrochloride hard gelatin capsules in 500mg and 850mg strengths. The 500mg twice-daily dosing is the standard initiation regimen, while 850mg is used in patients requiring higher doses or those titrated up for optimal glycaemic control.

    • 03

      Yes. Metformin is a WHO Essential Medicine and is recommended as the first-line pharmacological agent for Type 2 diabetes mellitus by the WHO, ADA (American Diabetes Association), EASD and most international treatment guidelines. It remains the most widely prescribed oral antidiabetic globally.

    • 04

      No. Unlike sulphonylureas, Metformin does not stimulate insulin secretion and therefore does not cause hypoglycaemia when used as monotherapy. It is also weight-neutral or associated with modest weight reduction — an important advantage in obese patients with Type 2 diabetes.

    • 05

      Yes. Metformin is part of 9M India's institutional and government supply portfolio. We support large-volume procurement with flexible packaging, complete documentation and the ability to meet tender specifications. Please contact our export team with programme requirements.

    • 06

      9M India manufactures a comprehensive antidiabetic portfolio including Metformin + Glibenclamide, Metformin + Glimepiride, Metformin + Sitagliptin and Metformin + Gliclazide combination tablets. Please request our complete antidiabetic product list for export enquiries.

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