Antidiabetic (antihyperglycemic) & potential antineoplastic used for patients with type 2 diabetes.
Drug Class
Manufacturing this API involves a one-pot reaction of dimethylamine hydrochloride and 2-cyanoguanidine
API Technology
Commercialized with an installed capacity of 7200 MT/Annum.
Development Status
US/EU/ANVISA/NMPA
Regulatory Fillings
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IOLCP’s Footprint in Metformin API
IOL Chemicals and Pharmaceuticals Limited is a trusted global manufacturer of Metformin API, supplying pharmaceutical companies worldwide through a dedicated manufacturing facility built on stringent quality systems and pharmacopeial and ICH compliance. With an installed capacity of 7,200 MT per annum and tight control over critical parameters such as NDMA, IOLCP delivers consistent purity, safety, and supply reliability at scale.This manufacturing strength reinforces our standing in the Metformin API market and gives customers greater confidence in our Metformin API price through dependable quality, regulatory readiness, and long-term supply assurance.
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- As one of the trusted Metformin Hydrochloride API manufacturers, IOLCP produces high-quality Metformin Hydrochloride active pharmaceutical ingredients in its dedicated manufacturing facility.
- The Metformin Hydrochloride API production follows the highest quality protocols, including the Pharmacopeial and ICH guidelines, to ensure safety and regulatory compliance.
- The Metformin synthesis process used by IOLCP ensures that NDMA content is maintained below 1 ppb, which is significantly below the 32 ppb limit. Also, we take strict precautions in maintaining control over Dimethylamine during the formulation phase to prevent any NDMA formations.
- To support varied pharmaceutical manufacturing and distribution requirements, IOLCP offers Metformin Hydrochloride API in multiple packaging formats. Standard packing includes 25 kg and 50 kg HDPE drums, with additional options such as corrugated boxes, jumbo bags, fibre drums, and HDPE laminated paper bags available based on customer and shipping requirements.
Indication
Adults with type 2 diabetes mellitus can improve their glycemic control by using Metformin as an adjunct to diet and exercise.
Polycystic ovary syndrome is another condition for which metformin is prescribed.
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Frequently Asked Questions
As one of the leading metformin hydrochloride API manufacturers, IOLCP works closely with clients to meet their unique requirements. The products meet the highest quality standards and comply with Pharmacopeial and ICH regulations. For more information, contact our sales team at +91 161 2225531.
With an expanding global reach, IOLCP, a trusted metformin hydrochloride API manufacturer, ships Metformin Hydrochloride API worldwide, including to key markets like China, following NMPA’s CDE regulatory approval. The products are packaged in 25 kg and 50 kg HDPE drums to ensure safe transport.
IOLCP offers streamlined support to clients sourcing metformin hydrochloride active pharmaceutical ingredients. Our sales team are extremely prompt in handling inquiries on product specifications, technical assistance, and exploring potential collaborations with top pharma companies.
IOLCP's Metformin Hydrochloride API ticks off several global regulatory standards, including CDE of NMPA in China, ensuring its availability for export. The company also ensures adherence to pharmacopeial specifications and ICH guidelines.
In order to maintain compliance with cGMP, IOLCP follows strict quality control for the production of metformin hydrochloride active pharmaceutical ingredient. The production procedure meets international pharmacopeial standards & complies with ICH guidelines to deliver APIs with the highest purity.