Wanbury jumps 4% after firm gets zero form 483 observations from USFDA

Shares of pharma company Wanbury climbed nearly 4 per cent on Friday after the company received an EIR with zero form 483 observations, from the USFDA

Shares of pharmaceutical firm Wanbury climbed on Friday's trading session after the company received an Establishment Inspection Report (EIR) with zero form 483 observations from the United States Food and Drug Administration (US FDA) agency, for its manufacturing facility located at MIDC Industrial Area, in Patalganga, Maharashtra.
 

The company, in an exchange filing on Friday morning, said that the inspection by the US federal drug administration agency has been successfully closed.

At around 9:50 AM, Wanbury's shares were trading at Rs 216.56, up by 3.27%, on the BSE, while the 30-stock BSE Sensex was trading lower by 0.02 per cent at 81,041. 

 

The market capitalisation of the company around the same time stood at Rs 709 crore. 

According to the company's exchange filing, USFDA has determined that the inspection classification of this facility is 'No Action Indicated' (NAI) with zero form 483 observation. 

Further, based on this inspection, the facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP), the company added.

The company, in an exchange filing, said, "The USFDA has issued an Establishment Inspection Report for the Company’s manufacturing facility located at MIDC Industrial Area, Patalganga, Maharashtra, India and the inspection has now been successfully closed by the USFDA." 

"US FDA has determined that the inspection classification of this facility is 'No Action Indicated' with zero 483 observation," it added.

The company's Patalganga, Maharashtra-located manufacturing facility had also received two awards recently. One was for lowest average accident frequency rate, while the other one was for longest accident-free period.

Wanbury has a strong presence in the global Active Pharmaceutical Ingredient (API) market and domestic branded formulations market.

With a basket of over 13 API products, the company's operation is majorly focussed on API sales and marketing in over 50 countries. The company also has a significant pan-India formulation presence.

The company's shares have given returns of more than 45 per cent in the past three months, compared to benchmark BSE Sensex's returns of 7.52 per cent during the same period.

Wanbury's shares have gained around 300 per cent in one year, compared to a climb of nearly 24 per cent for the BSE Sensex during the same time.