New capabilities to support pharmaceutical clients at Megsan

The team of Megsan recently developed a common method for determining seven nitrosamine impurities by LC-MS. This facilitates many pharma clients to test their product with a single method.

Further, Megsan demonstrates the capability to test Azido tetrazole impurities (Genotoxic), a new class of mutagenic impurities in sartans – i.e. drugs commonly used to treat hypertension, heart and kidney diseases. The method development and validation by UPLC, LC-MS for sartan molecules is now completed.

Megsan Labs also extended Extractable and Leachable studies for biosimilar products (monoclonal antibodies).

New projects in 2022

Megsan proved technical competency by taking up challenging studies like nitrosamine impurities in hydrogenated vegetable oil-based modified release formulation, In use microbiological study for single and multi-dose injections. Another capability on Kill rate study for injectables is being developed and soon will be made available to clients.

Currently, Megsan Labs serve all major pharmaceutical companies across India to support them with regulatory issues. With its excellent scientific team, they develop and validate methods according to regulatory requirements.

Mr. Jayapal Reddy, CEO of Megsan Labs, is excited for 2022: “We look forward to add a food testing lab at our existing premises this year. The lab set up is moving in very fast pace and expected to get into commercial operations by August 2022, including certifications like NABL/EIC/FSSAI.”

About Megsan Labs

Megsan is a US-FDA Inspected, ISO 17025 Accredited, FSSAI approved and DCGI (Drug Controller General of India -Indian FDA) approved Laboratory, which provides analytical testing services to pharmaceutical and related companies. The services comprise elemental impurity studies, E&L studies, method development & validation and microbiological testing.

Jayapal Reddy and Jyothirmai Madireddy founded the company in 2012. For more information, please visit www.megsanlabs.com.