Granules India share tanks 10% after USFDA's 'OAI' tag for Gagillapur Unit

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has classified the inspection of Gagillapur unit as OAI

Granules India share price: Shares of pharmaceutical company Granules India stock dropped up to 9.99 per cent to hit an intraday low of Rs 535.20 per share on Tuesday, December 3, 2024. 

 

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has classified the inspection of Gagillapur unit as ‘Official Action Indicated’ (OAI).  An OAI tag from the USFDA means that a unit is not in compliance with applicable laws and regulations.

 

Granules India was inspected between August 26 and September 6, 2024, and was given six observations. 

 

The company has responded to all the observations issued by the USFDA, Granules India claimed. 

 

Additionally, the company has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility. This activity is undertaken in consultation with external subject matter experts.

 

“The company will work with the USFDA on this activity and is confident that it will result in the USFDA approving the Company’s facility at Gagillapur in compliance with its expectations within a short time,” Granules India said. 

 

About Granules India

  

Granules India, headquartered in Hyderabad, India, is a major pharmaceutical company specialising in the manufacture and distribution of a diverse range of products, including active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs) such as paracetamol, ibuprofen, metformin, guaifenesin, and methocarbamol. 

 

Serving a broad customer base that includes both generic and branded pharmaceutical companies, Granules India distributes its products across over 55 countries, including major markets like the US, Canada, and India. 

 

Additionally, the company engages in contract research and manufacturing (CRAM) and operates a consumer health division, Granules Consumer Health (GCH), which focuses on large-volume pharmaceutical products.

 

The market capitalisation of Granules India is Rs 13,067.31 crore, according to BSE. The company falls under the BSE500 category. 

 

Granules India’s 52-week high is Rs 724.55 apiece, while its 52-week low is Rs 365.70 per share. 

 

At 3:00 PM, shares of Granules India were trading lower, down 9.50 per cent at Rs 538.15 per share. In comparison, BSE Sensex was trading 0.77 per cent higher at 80,865.40 levels.