Strides Pharma gets renewed GMP certificate from UK MHRA

Strides Pharma Science Limited has informed the bourses about the successful completion of the inspection carried out by UK Medicines and Healthcare products Regulatory Agency (UK MHRA) at its Puducherry facility between October 15 and 18, 2019.

The company has now received the renewed certificate of good manufacturing practices (GMP) thereby, confirming the successful closure of the inspection. Puducherry facility caters to the United States, other regulated markets as well as institutional businesses and has capabilities to produce finished dosage formulation products across multiple dosage formats.

However, United States Food & Drug Administration (USFDA) had reclassified this facility as official action indicated (OAI) and the company had received a warning letter in July 2019. Post this, the company completed and submitted all corrective and preventive action (CAPA) plans, verified by an external remediation consultant, and requested FDA to re-inspect the site. The inspection has been delayed due to the COVID-19 pandemic.

Strides Pharma mainly operates in the regulated markets and its global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (Florida). It focusses on the products that are ‘difficult to manufacture’ and are sold in over 100 countries.

On Wednesday, the stock of Strides Pharma opened at Rs 573.90. During the day, it surged 3.2 per cent making an intraday high of Rs 587.25 from its previous close of Rs 568.85 on BSE.