Cipla receives 8 GMP observations for Kurkumbh Plant

01 Apr 2019 Evaluate

US Food and Drug Administration (USFDA) has conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at Cipla's Kurkumbh plant from March 11, 2019 to March 20, 2019. The inspection covered 3 units at the plant. Post the conclusion of the inspection, the Company has received 8 GMP observations.

The Company has also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024. These observations are both product specific and GMP observations related to the manufacturing and quality processes.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

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