• search
Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Product development in a challenging IP landscape Product development in a challenging IP landscape

Product development in a challenging IP landscape

Project challenge: Identication of suitable chiral reagent for chemical resolution, process validation, desired polymorph. Solution design: Often API development is bound by IP constraints. In order to develop a scalable and robust process to address IP challenges, the following approach was adopted by the CPS team. Non-infringing route to circumvent IP barrier was proposed Screening of chiral resolving agents and solvents to yield the maximum eciency in terms of yield and highest desired enantiomer Polymorph screening with dierent solvent systems and a range of temperatures furnished the requisite Process developed in lab was demonstrated in plant by performing three process validation batches yielding the product with desired quality and culminating in regulatory filingConclusion: Our team has demonstrated the ability to develop processes for commercial API that are already in the market with restrictions in IP and enable the submission of a regulatory filing.

Product development in a challenging IP landscape

Contact Us

Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
×

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.

ProceedBack