Dapagliflozin Capsule Manufacturer in India

About

About Dapagliflozin Capsules — 9M India

9M India manufactures Dapagliflozin hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Dapagliflozin is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor — one of the newer class of antidiabetic agents with proven cardiovascular and renal protective benefits beyond glycaemic control. Available in 10mg strength, our capsules are manufactured under WHO-GMP conditions with complete in-house analytical testing and stability data.

Capsule formulation specifications

Specification	Details
Molecule	Dapagliflozin Propanediol Monohydrate
Dosage Form	Hard Gelatin Capsule
Available Strengths	10mg
Pharmacopoeial Standard	USP
Therapeutic Class	Antidiabetic — SGLT2 Inhibitor
Pack Options	10 capsules / 14 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 Dapagliflozin capsules to regulated and semi-regulated markets across the Middle East, CIS countries and ASEAN. 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 Dapagliflozin capsule supply

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

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WHO-GMP
Certified
Export
Ready
15+ Countries
Supplied
DCGI
Approved

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We keep answer short

Frequently asked questions — Dapagliflozin capsules

01

9M India manufactures Dapagliflozin hard gelatin capsules in 10mg strength at its WHO-GMP certified facility in Birkoni, Chhattisgarh. The formulation is DCGI approved and available for export to the Middle East, CIS countries and ASEAN markets.
02

Dapagliflozin selectively inhibits SGLT2 (sodium-glucose co-transporter 2) in the proximal renal tubule, reducing reabsorption of filtered glucose and increasing urinary glucose excretion. This insulin-independent mechanism lowers blood glucose, reduces body weight and lowers blood pressure — without causing hypoglycaemia.
03

Yes. Clinical trials (DECLARE-TIMI 58, DAPA-HF, DAPA-CKD) have demonstrated that Dapagliflozin significantly reduces cardiovascular events in patients with established cardiovascular disease, reduces hospitalisation for heart failure, and slows progression of chronic kidney disease — benefits independent of its glucose-lowering effect.
04

Dapagliflozin is approved at 10mg once daily for Type 2 diabetes mellitus, heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD). It is used as monotherapy or in combination with Metformin, insulin and other antidiabetic agents.
05

Yes. 9M India supplies Dapagliflozin capsules for export with WHO-GMP Certificate, CoPP, batch CoA, stability data and CTD/ACTD dossier support. Please contact our export team for pricing, MOQ and registration documentation.
06

While 9M India currently manufactures Dapagliflozin as a standalone capsule, fixed-dose combination formulations with Metformin are under development. Please contact our team for the latest product development updates and enquiry.