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Cipla in focus after 8 GMP observations from USFDA

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Cipla informed that the US FDA conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at its Kurkumbh plant from 11 March 2019 to 20 March 2019. The inspection covered 3 units at the plant. Post the conclusion of the inspection, the company received 8 GMP observations. The company 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. There are no data integrity (DI) observations. The company is committed to addressing these observations and will submit its response to the agency within the stipulated time. The announcement was made yesterday, 31 March 2019.

Dr Reddy's Laboratories said that furtherance to intimation dated 12 November 2018, wherein the company informed that Formulations Manufacturing facility in Duvvada, Vishakhapatnam was considered compliant by the Regulatory Authority of Germany (Regiemng von Oberbayem) and continued our EU-GMP certification with a specific exclusion of one new product. In this regard, the company informed now that the facility has been re-inspected by the authority and considered to be fully compliant. The announcement was made after market hours on Friday, 29 March 2019.

Havells India has now started commercial production of Air Conditioners at its Ghiloth plant. The announcement was made after market hours on Friday, 29 March 2019.

Welspun Corp announced value unlocking of approx. Rs. 940 crore through the divestment of its Plate and Coil Mill Division (PCMD) and its 43 MW Power Division. The announcement was made yesterday, 31 March 2019.

CreditAccess Grameen completed a Securitization of Rs 93.83 crore on 30 March 2019. With this transaction, the company has completed seven securitization and four Direct Assignment transactions totaling to Rs 1667.05 crore in FY19. The announcement was made yesterday, 31 March 2019.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, April 01 2019. 08:41 IST
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