Cipla falls after US subsidiary receives 5 observations from FDA

Shares of Cipla Limited declined 2 percent to Rs 1,215 in morning trade on September 21 after its wholly-owned US subsidiary, InvaGen Pharmaceuticals,  received 5 inspectional observations from the United States Food and Drug Administration (USFDA).

“We notify that the inspection was conducted at the manufacturing facility of InvaGen located in Central Islip, Long Island, New York, USA, from 11th September 2023 to 19th September 2023”, the company said in an exchange filing on September 20.

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“At the conclusion of the inspection, InvaGen has received 5 inspectional observations in Form 483”, the disclosure stated. Cipla also added that there is no repeat or data integrity (DI) observations. “The company will work closely with the USFDA and is committed to addressing these comprehensively within the stipulated time.”

The form 483 is issued if FDA finds deficiencies in quality system or regulatory violations.

Motilal Oswal, in its recent report, upgraded its rating to ‘Buy’ on a healthy growth outlook coupled with robust revenue and profit expectations.

Cipla has been a frontrunner among pharma companies under MOFSL’s coverage during FY13-23 as it recorded a US sales CAGR (Compounded Annual Growth Rate) of 21.6 percent to reach $733 million by the end of the decade.

Also read: Torrent Pharmaceuticals in talks with CVC Capital for funding Cipla purchase

The company also proved its mettle as it recorded 8 percent on-year sales growth in FY23 despite struggling with high price erosion within the industry, thanks to robust sales of the generic blockbuster cancer drug Revlimid and market share gains in lanreotide (used to treat carcinoid syndrome), albuterol (a respiratory drug) and arformoterol (used to treat chronic obstructive pulmonary disease).

At 11.37 am, the stock was trading at Rs 1,218.60 on the National Stock Exchange, down 1.7 percent from the previous close.

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