USFDA issues notice to Cipla for its Indore plant; stock slips 2%

The US Food and Drug Administration (USFDA) has served 9 observation and has issued a memo notice to Cipla Ltd for its Indore plant.

Shares of Cipla Ltd are currently trading lower at Rs. 670, down by 2.4% on BSE. The US Food and Drug Administration (USFDA) has served 9 observation and has issued a memo notice to Cipla Ltd for its Indore plant. The US drug regulator had inspected Cipla’s Indore facility during July and August this year.

The US FDA investigators noted that the company’s quality control unit lacked authority to review production data and failed to assure error-free production.

The investigation further found that the aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

The US FDA inspection noted that the sterile filling lines were frequently opened in order to complete manual interventions during product filling. "In the packaging hall, sterile product vials exiting the filling line were handled with ungloved and unsensitized hands by packaging line employees...," said the FDA in Form 483.

The scrip opened at Rs. 688.1 and has touched a high and low of Rs. 688.1 and Rs. 659.3 respectively. So far 4679810(NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs. 55181.33 crore.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 752.45 on 10-Mar-2015 and a 52 week low of Rs. 572 on 15-Jun-2015. Last one week high and low of the scrip stood at Rs. 688.7 and Rs. 660.25 respectively.

The promoters holding in the company stood at 36.79 % while Institutions and Non-Institutions held 34.3 % and 26.6 % respectively.

The stock is currently trading below its 50 DMA.