Metformin HCl & Glimepiride DC Granules

Product Overview

Metformin HCl & Glimepiride DC Granules are ready-to-use, pre-formulated intermediate designed for direct compression into tablets. This combination granule formulation offers the synergistic antidiabetic effects of Metformin (biguanide class) and Glimepiride (sulfonylurea class), targeting multiple pathways to improve glycemic control in patients with Type 2 Diabetes Mellitus.

Product Name
Metformin Hydrochloride & Glimepiride Direct Compression (DC) Granules
Strengths Available
80.16% & 80.32% (%w/w) (customizable per your offering)
CAS No. / IUPAC Name
Metformin HCl: CAS 1115-70-4; IUPAC: 1,1-Dimethylbiguanide hydrochloride
Glimepiride: CAS 93479-97-1; IUPAC: 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] phenyl]-3-(trans-4-methylcyclohexyl) urea
Molecular Formula / Weight
Metformin HCl: C₄H₁₁N₅·HCl / ~165.63 g/mol
Glimepiride: C₂₄H₃₂N₄O₅S / ~490.6 g/mol
Identification
Validated HPLC methods for both APIs as per USP / BP / EP standards
Release Type
Immediate Release (IR) suitable for direct compression into oral solid dosage forms
Applications
Fixed-dose combination antidiabetic therapy for improved glycemic control in Type 2 diabetes mellitus, Enables formulation of tablets with synergistic dual action: Metformin’s insulin sensitization and Glimepiride’s insulin secretion stimulation
Storage Conditions
Store in a tightly closed container, away from moisture, heat, and direct light. Recommended storage at controlled room temperature (15°C – 25°C).

Metformin HCl & Glimepiride DC Granules – Typical Composition

Component	Function
Metformin Hydrochloride (HCl)	Primary Active Pharmaceutical Ingredient (API) – Biguanide class; improves insulin sensitivity and reduces hepatic glucose production
Glimepiride	Secondary Active Pharmaceutical Ingredient (API) – Sulfonylurea class; stimulates insulin secretion to lower blood glucose
Pregelatinized Starch / Starch 1500	Binder & Disintegrant – Provides mechanical strength to granules and ensures rapid disintegration for both APIs
Colloidal Silicon Dioxide	Glidant – Enhances the flowability of the combined granules and prevents powder bridging/clumping during processing
Magnesium Stearate	Lubricant – Prevents sticking of combined granules to punches and dies during direct tablet compression
Purified Water	Granulating Solvent – Used during wet granulation to bind both APIs with excipients (evaporated during drying)

Why Choose Granules from Salius Pharma?

Outsourcing DC Granules through a trusted partner like Salius Pharma can be a strategic decision to save both time and resources, without compromise on quality or compliance.
Instead, partnering with Salius Pharma—a leading distributor aligned with USFDA-approved and WHO-GMP-certified manufacturers in India—allows you to leverage high-quality products, seamless logistics, and professional support under one roof.

Key Advantages of Partnering with Salius Pharma

Cost-Efficient Setup
Avoid heavy capital investment in infrastructure and workforce.
Guaranteed Quality Assurance
Products are sourced only from certified facilities with validated processes.
Access to Advanced Technology
Benefit from the latest drug delivery systems without managing the tech in-house.
Accelerated Market Entry
Launch products faster and establish your brand in less time.
Custom Formulation Support
Flexibility to offer tailored pellet solutions as per your market needs.

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.

Place an Order or Request a Quote from Salius Pharma

Looking to source Metformin HCl & Glimepiride DC Granules or other high-quality pharmaceutical pellet formulations?
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

Get in Touch

Email: export@saliuspharma.com
Call / WhatsApp: +91 84258 80640 / +91 84258 80643
Landline: +91 22 49700 601 / +91 22 44503 148
Corporate Office: 3104–3106, Plan S Business Park, Nerul MIDC Opp. Dr. D.Y. Patil Stadium, Navi Mumbai – 400706, Maharashtra, India

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FAQs

These are ready-to-compress combination granules containing both Metformin Hydrochloride and Glimepiride. Designed for immediate release, they allow direct compression into fixed-dose combination (FDC) tablets without the need for wet or dry granulation at the manufacturing site.

Effects include hypoglycemia, nausea, diarrhea, headache, and altered taste; long-term use may cause vitamin B12 deficiency, requiring regular monitoring.

They treat type 2 diabetes mellitus as an adjunct to diet and exercise, especially when monotherapy fails, improving glycemic control in patients on separate glimepiride and metformin.

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