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Metabolic / Diabetes

Metformin Hydrochloride API Supplier

Name: Metformin Hydrochloride API
Brand: Generic Specialty Group
Availability: InStock

CAS 1115-70-4 · Metabolic · Biguanide · Antidiabetic

GMP-certified Metformin Hydrochloride API — the world's most prescribed antidiabetic. USDMF and CEP on file. Nitrosamine (NDMA) testing completed and documented with every batch.

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Purity≥99.0%HPLC

MOQ100 kgHigh-volume generics

RegulatoryUSDMFNitrosamine tested

Response24 hrFull dossier

OriginMultiIndia / China

Technical Specifications

Metformin Hydrochloride API — Full Technical Profile

INN / Generic Name	Metformin Hydrochloride
CAS Number	1115-70-4
Molecular Formula	C₄H₁₁N₅·HCl
Molecular Weight	165.6 g/mol
Mechanism / Class	Biguanide — reduces hepatic glucose production, improves insulin sensitivity
Therapeutic Use	Type 2 Diabetes Mellitus; increasingly studied for oncology and longevity
Purity (HPLC)	≥99.0%
Appearance	White crystalline powder; hygroscopic
Storage	Store below 30°C in tightly closed containers
MOQ (commercial)	100 kg
MOQ (R&D)	1 kg – 10 kg
Lead Time	2–5 weeks
Regulatory Filings	USDMF + CEP
Country of Origin	India / China

Regulatory Documentation

Complete Source Quote — What's Included

Every Metformin Hydrochloride API inquiry returns a complete regulatory package in 24 hours.

📋

Certificate of Analysis

Full CoA — assay ≥99.0%, related substances, heavy metals, NDMA (nitrosamine) result, residual solvents.

✓ Included

🇺🇸

USDMF on File

US Drug Master File active. Supports FDA ANDA filings.

✓ On File / Active

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CEP Certified

Certificate of Suitability (Ph.Eur.) for EMA submissions.

✓ CEP Issued

⚠️

Nitrosamine (NDMA) Testing

Per FDA/EMA guidance — NDMA confirmatory testing completed on each batch. Results included in dossier.

✓ Tested / Documented

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Impurity Profile

Full ICH Q3A characterisation including cyanoguanidine and all process-related impurities.

✓ Included

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Stability Data

ICH Q1A long-term stability at 25°C/60% RH and 40°C/75% RH accelerated.

✓ Included

Market Context

Metformin Hydrochloride — Key Figures

200M+

Patients worldwide

NDMA

Fully tested / documented

Major regulatory filings

2–5 wk

Lead time

Complete Source Quote

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Submit your requirements. We'll respond with a complete package within 24 business hours.

Certificate of Analysis (CoA)
USDMF + CEP — reference letter / status
Full impurity profile per ICH Q3A
Stability data summary
GMP certificate + site details
Pricing, MOQ, and lead time
Country of origin confirmation

Metformin Hydrochloride API Inquiry

Complete Source Quote · 24-hour response

Common Questions

Metformin Hydrochloride API — FAQ

Is NDMA (nitrosamine) testing included for Metformin?

Yes — nitrosamine (NDMA) confirmatory testing is performed on every batch per FDA and EMA guidance issued following the 2019–2020 Metformin recalls. Test results and the risk assessment are included in the regulatory dossier as standard.

Is Metformin available in extended-release (XR) grade?

We supply pharmaceutical-grade Metformin HCl API suitable for both immediate-release and extended-release formulations. Particle size distribution and flow properties data is available to support your XR formulation development.

What is the commercial MOQ for Metformin HCl?

Commercial MOQ is 100 kg. Given the high-volume nature of Metformin, we can also facilitate 500 kg and metric-tonne scale orders. R&D quantities from 1 kg are available for qualified buyers.

Does Generic Specialty Group manufacture Metformin Hydrochloride?

No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.

Metformin Hydrochloride API Supplier

Metformin Hydrochloride API — Full Technical Profile

Complete Source Quote — What's Included

Metformin Hydrochloride — Key Figures

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Metformin Hydrochloride API — FAQ

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