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Development of Prussian Blue formulations under GMP Facility

Project

Development of Prussian Blue formulations under GMP Facility

Project Description

The instant project requirement comprises Development of Prussian Blue insoluble formulations under GMP Facility for Nuclear Warfare. Prussian blue formulations have been developed and evaluated at laboratory scale. The formula of Prussian blue formulations and method of preparation has been developed and evaluated at laboratory level and validated with batches of upto 100 gm. The formulations developed at Laboratory level comprise Prussian blue along with pharmaceutical excipients. The analytical method based on UV spectroscopy has been developed and validated at Laboratory level. To develop these formulations further, various parameter needs to be performed & evaluated which include scaling up of the production under GMP facility, taking process validation batches, generating stability data of the batches prepared under GMP, conducting in vitro efficacy studies or bioequivalence studies and/or generating any other additional data required for regulatory approval from competent authority i.e CDSCO. This part for the formulation development is technology oriented and scale-up technology can be developed under GMP facility of a Pharmaceutical Industry only.

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Project Awarded To

scott-edil pharmacia Ltd


Company Profile :
SCOTT-EDIL Pharmacia Limited was incorporated in 2003 as a limited company registered under The Companies Act, 1956. SCOTT-EDIL Pharmacia Limited is primarily engaged in the business of manufacturing of drug formulations and chemicals. The main promoter of the Group is Mr. Balram Krishan Aggarwal, who laid the foundation of the family business in 1988. The family has a strong background in pharmaceutical business and has been able to capitalize on its expertise by expanding into multiple products under its own brand name of SCOTT-EDIL. The products command high repeat buying pattern amongst the distributors and retailers due to good quality, attractive packaging and price points. SCOTT-EDIL has State-of-the-Art manufacturing technology where international quality standards are followed in the ultra-modern plant.