Cipla falls after 8 GMP observations from USFDA

Cipla fell 0.9% to Rs 524.55 at 10:13 IST on BSE after the USFDA issued 8 GMP observations while inspection of its Kurkumbh plant.

The announcement was made yesterday, 31 March 2019.

Meanwhile, the S&P BSE Sensex was up 318.41 points, or 0.82% to 38,991.32

On the BSE, 13.68 lakh shares were traded in the counter so far compared with average daily volumes of 5.16 lakh shares in the past two weeks. The stock had hit a high of Rs 527.80 and a low of Rs 515.90 so far during the day.

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.

Cipla 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, Cipla said.

Cipla's consolidated profit after tax fell 17% to Rs 332 crore on 2% rise in total revenue from operations to Rs 4008 crore in Q3 December 2018 over Q3 December 2017.

Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in home markets of India, South Africa, North America, and key regulated and emerging markets.

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