Strides Pharma Shares Tank 3% as Units Get 4 USFDA Observations 

Shares of Strides Pharma Science Ltd tanked 3% on 25 December after the company’s formulation facility received 4 observations from the USFDA. 

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at its wholly-owned subsidiary, Strides Pharma Inc (SPI), formulation facility. 

The inspection was conducted from 17 to 23 December at Strides Pharma Inc.’s Chestnut Ridge facility in New York, following which the USFDA issued a Form 483 with four observations. 

The company clarified that the observations relate only to procedural matters and will not affect the supply of its commercial products. It also said it will submit a detailed response to the regulator within the prescribed timeline and remains confident of resolving all observations to the FDA’s satisfaction.

Strides Pharma Science Limited operates as an Indian pharmaceutical company with its headquarters in Bengaluru. The company develops and manufactures a wide range of pharmaceutical products, including over-the-counter medicines and nutraceuticals. Its portfolio covers softgel capsules, hard-gel capsules, tablets, and both dry and liquid injectable formulations. Strides runs 15 manufacturing facilities across six countries and markets its products in nearly 50 countries worldwide.

At 12:10 pm, the shares of Strides Pharma were trading 2.81% lower at Rs 943.80 on NSE.

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