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Granules India Shares Gain 2% on 1 Observation from USFDA

Granules India
The company said this product has an estimated market size of around $41 million in the US.

Shares of Granules India Ltd were trading 2% higher on 23 June after the company announced receiving one observation from the US FDA for its Hyderabad facility.  

In its regulatory filing, the company said, “The company’s API Unit-I facility located at Bonthapally Village, Sangareddy District, Hyderabad, Telangana, India has completed a USFDA inspection from 16 June, 2025 to 20 June, 2025 with one 483 observation.”

The corporation will reply to this observation within the timeframe specified, it stated.  

The Bonthapally plant is one of the world’s largest single-site Paracetamol API manufacturing facilities in terms of volume. Along with Paracetamol APIs, the company has set up manufacturing lines for Metformin and Guaifenesin APIs on the same site.

On 02 September 2024 and 07 April 2025, the shares reached a 52-week high of Rs 724.55 and a low of Rs 412.05, respectively. 

At 12:06 pm, the shares of Granules India were trading 2.01% higher at Rs 497.15 on NSE.

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