The chemical formula for metformin hydrochloride is C4H12ClN5, and it is an active pharmaceutical ingredient (API). It appears in a fine white crystal form. The hydrochloride salt of the biguanide metformin, which has potential anti-cancer and anti-hyperglycemic properties, is called metformin hydrochloride. A biguanide hypoglycemic medication treats non-insulin-dependent diabetic Mellitus when dietary changes are ineffective. It includes metformin, a guanidine biguanide with two methyl substituents at position one, and belongs to the class. For type 2 diabetic patients, the final Metformin HCl pills made from this API regulate blood sugar levels. It aids in decreasing the amount of sugar the liver produces, limiting the quantity of sugar ingested through food, and increasing the sensitivity of insulin receptors.
Product Specific Details
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CAS No.
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1115-70-4
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HS Code
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29252990
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Grade
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USP, IP, Ph. Eur/EP
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Approved Facility
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CDSCO (FDA India), USFDA
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Certifications
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GMP, cGMP, CEP
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Approved Facility/Certification Definitions:
CDSCO- The Central Drugs Standard Control Organization (CDSCO) - Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
USFDA - The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. FDA is also responsible for advancing the public health by accelerating innovations to make medicines more effective and providing the public with accurate, science-based information on medicines and food to improve their health. FDA plays a significant role in addressing the Nation's counterterrorism capability and ensuring the security of the food supply.
GMP- Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
cGMP- It refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations.
CEP - The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph.
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