Antidiabetic

Sitagliptin + Metformin HydrochlorideThird Party Manufacturing in India

Looking to get Sitagliptin + Metformin Hydrochloride manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
486460-32-6 (Sitagliptin); 1115-70-4 (Metformin HCl)
Drug Class
DPP-4 inhibitor + Biguanide combination
Molecular Formula
C₁₆H₁₅F₆N₅O (Sitagliptin); C₄H₁₂ClN₅ (Metformin HCl)
Molecular Weight
407.31 g/mol (Sitagliptin); 165.63 g/mol (Metformin HCl)
Grade Standards
IP, USP, BP
Therapeutic Category
Antidiabetic
MOQ
10,000 tablets per batch
Dosage Forms
Tablet

Mechanism of Action

Sitagliptin + Metformin Hydrochloride combines two complementary antidiabetic agents with distinct mechanisms of action for synergistic glycemic control. Sitagliptin is a potent DPP-4 inhibitor that increases active incretin hormone levels by preventing their degradation. This leads to glucose-dependent insulin secretion from pancreatic beta cells and suppression of glucagon release from alpha cells, working only when blood glucose is elevated to minimize hypoglycemia risk. Metformin Hydrochloride is a biguanide antidiabetic that primarily works by reducing hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis. Metformin also improves peripheral insulin sensitivity by increasing glucose uptake in skeletal muscle and adipose tissue, and reduces intestinal glucose absorption. The combination provides complementary glucose-lowering effects. Sitagliptin addresses the incretin deficiency common in type 2 diabetes, enhancing the body's own insulin response to meals. Metformin targets insulin resistance and excessive hepatic glucose output, the two core defects of type 2 diabetes. When used together, these agents achieve synergistic improvement in glycemic control. Sitagliptin counteracts the compensatory increase in glucagon that may occur with metformin alone, while metformin addresses the insulin resistance that limits sitagliptin's effectiveness. The combination is weight-neutral and associated with a very low risk of hypoglycemia. This dual-mechanism approach is recommended by clinical guidelines for patients who fail to achieve glycemic targets on metformin monotherapy.

Therapeutic Uses & Indications

Therapeutic Uses

Sitagliptin + Metformin Hydrochloride is prescribed for the treatment of:

  • Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults.
  • Add-on to Metformin Monotherapy: For patients with inadequate glycemic control on metformin alone.
  • Switch Therapy: For patients already controlled on separate sitagliptin and metformin tablets, simplifying their regimen into a single tablet.
  • Combination with Sulfonylurea or Insulin: As part of triple therapy in advanced disease management for patients requiring additional control.

Why Manufacturers Choose Sitagliptin + Metformin

Sitagliptin + Metformin Hydrochloride is one of the most prescribed fixed-dose combinations in diabetes management globally. The Indian market for this combination is substantial, driven by the high prevalence of type 2 diabetes and clinical preference for combination therapy over monotherapy. Indian manufacturers benefit from the large patient pool, established prescription patterns, and the convenience of a single-tablet regimen that improves patient compliance. The product is manufactured in two common strengths to accommodate different dosing requirements. This combination is particularly attractive for PCD franchise operators targeting endocrinology and general medicine channels. This makes Sitagliptin + Metformin one of the most sought-after combinations for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
50mg+500mg · 50mg+1000mg

Frequently Asked Questions

What is the minimum order quantity for Sitagliptin + Metformin Hydrochloride?
Minimum order quantity for Sitagliptin + Metformin Hydrochloride is 10,000 tablets per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Sitagliptin + Metformin Hydrochloride can you manufacture?
We manufacture Sitagliptin + Metformin Hydrochloride as: Tablet (50mg+500mg, 50mg+1000mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Sitagliptin + Metformin Hydrochloride for export?
Yes. We provide export-ready Sitagliptin + Metformin Hydrochloride formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Sitagliptin + Metformin Hydrochloride?
We manufacture Sitagliptin + Metformin Hydrochloride to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Sitagliptin + Metformin Hydrochloride made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • MOQ from 10,000 tablets per batch
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle, Mono carton. Packaging customized to client brand guidelines.

Start Manufacturing Sitagliptin + Metformin Hydrochloride Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Sitagliptin + Metformin Hydrochloride across all dosage forms. PCD franchise and export orders welcome.

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