SMS Lifesciences India has carried out a preliminary analysis of Ranitidine product and processes and found that the NDMA impurity is in trace levels, in many cases lower than the levels found in commonly consumed food, milk, meat etc. It is awaiting further directives from Central Drugs Standard Control Organization (CDSCO), regulatory agency to review and establish acceptable limits for NDMA (N-Nitrosodimethylamine) impurity in Ranitidine.
As regulatory guidance is awaited for limits of NDMA, the company sees a temporary slow-down in sales of Ranitidine which is one of the major contributor of revenues. The company anticipates business as usual in future as it is confident of providing a safe and stable Ranitidine product to all its customers, with NDMA impurity well within acceptable limits set by the Drug regulator, authorities.
SMS Lifesciences India is presently engaged in the business of manufacturing, buying, selling, offering consultancy, importing and exporting, acting as commission agents and generally dealing with of all types of Organic & Inorganic Chemicals, Pharmaceuticals, API and Intermediates.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1462.50 |
Dr. Reddys Lab | 5784.50 |
Cipla | 1451.25 |
Zydus Lifesciences | 1001.15 |
Lupin | 1587.90 |
View more.. |