Shares of Cipla rebounded more than 4.5 percent intraday on October 11 after management clarified on Goa unit inspection, saying there are no data integrity and repeat observations.
The stock fell nearly 8 percent in early trade today after seeing 12 observations issued for Goa unit last month.
But the clarification from management over observations helped the stock recover more than 13 percent from day’s low of Rs 389.55. It was quoting at Rs 439, up to Rs 16.75, or 3.97 percent on the BSE at 1350 hours IST.
“Site at Goa has about 10 units just to clarify across various dosage forms. If you read the 483 document there are no data integrity-related observations, no repeat observations there. We would not read too much into the number of observations. We still have some time to respond to them (US FDA). It should be soon,” Kedar Upadhye, Joint President and Global CFO, Cipla told CNBC-TV18.
He said the company is confident of being able to submit a robust response to the US FDA and this issue with the Goa plant is addressable.
Near-term pipeline from the site that received Form 483 is limited but there is no risk to existing commercialised business, and value of single source products from the plant is 2.5 percent of total revenues, he added.
The US Food and Drug Administration had inspected Cipla’s Goa unit during September 16-27, 2019 and issued 12 observations which are:
- Equipment & utensils are not cleaned at appropriate intervals
- Coloured drug product residues observed on inside surfaces of machines
Aseptic processing areas are deficient
- The building used in manufacturing and processing is not suitable to facilitate cleaning
- Procedures to prevent microbio contamination are not established
- Procedures to prevent microbio contamination didn’t include adequate validation
- There are no written procedures for the cleaning & maintenance of equipment
Specifications for in-process material are deficient
- There is no written procedure for production & process control
- Equipment used in manufacturing, packaging or holding of a drug product is not of appropriate design
- Failed to thoroughly review any unexplained discrepancy
- A written procedure is not reviewed and approved by the quality control unit
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