Cipla shares drop 2% after US FDA designates its Greece facility as OAI

Cipla share price fell 2.4 per cent to the day's low of ₹1,335.90 per share on the National Stock Exchange (NSE)

Cipla share price today

Cipla Limited shares faced significant selling pressure on Monday after the US Food and Drug Administration (US FDA) designated its manufacturing facility, located in Greece as an official action indicated (OAI).

 

Cipla share price fell 2.4 per cent to the day’s low of ₹1,309 per share on the National Stock Exchange (NSE). The stock was also the top loser in the Nifty Pharma index. 

 

As of 12:16 PM, Cipla share price was trading 1.52 per cent down at ₹1,320.7, as compared to a 0.38 per cent advance in the Nifty 50 index. The counter has seen a trade of 1.3 million shares on NSE so far. 

 

 

In the last 12 months, Cipla share price declined 10.51 per cent, as compared to a 12.6 per cent advance in the Nifty 50 index. 

 

Why did Cipla share price fall today?

US FDA classified the good manufacturing practices inspection of Pharmathen International S.A's manufacturing facility in Rodopi, Greece, as OAI. This development weighed on investors’ minds as the supply disruption of Lanreotide impacted Cipla’s performance during the December quarter (Q3FY26).   Pharmathen International S.A is the supply partner for Lanreotide Injection to Cipla USA Inc, the company said in the exchange filing. 

OAI, which often follows Form 483, is the most serious administrative classification a manufacturing facility can receive. This means that the manufacturing facility is seriously non-compliant with GMP regulations. This classification can also impact approval procedure for abbreviated new drug application (ANDA).   Q3 results key highlights 

Cipla’s net profit declined 57 per cent year-on-year (Y-o-Y) to ₹675 crore in the third quarter (Q3FY26), as compared to ₹1,570.51 crore a year ago. 

  Its revenue from operations remained flat at ₹7,074 crore, as compared to ₹7,072.97 crore in the same quarter a year ago.  Check Cipla’s Q3 results in detail

 

“Cipla’s Q3FY26 was materially weaker than expected, with the combined impact of a generic Revlimid decline and Lanreotide supply disruptions driving a sharp miss in the US topline and overall gross margin,” according to a Business Standard report.

 

North America sales declined 22 per cent on year to ₹1,485 crore in the third quarter compared to ₹1,906 crore in the same quarter a year ago.  The management said that they expect the re-supply of Lanreotide to start from the first half of the next financial year, in the investors' presentation for its December quarter performance. 

Analyst view

The US FDA has issued an OAI classification for the Pharmathen manufacturing facility in Greece, which Cipla had acquired in 2023 to strengthen its presence in complex injectables and respiratory products for regulated markets, said Harshal Dasani, business head, INAsset PMS

 

From a business standpoint, the near-term overhang is more sentiment-driven unless there are material disruptions in supply. Cipla’s US revenues contribute roughly 30 per cent to its consolidated topline, and the company has been focusing on specialty and differentiated launches, he said.

 

The key monitorable now will be the remediation timeline and management’s commentary on whether any pending ANDAs from the Pharmathen facility face delays. Historically, Indian pharma companies have resolved OAI classifications within a few quarters through corrective action plans, he added.

 

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