Strides Pharma Science Ltd said on Monday it has received the establishment inspection report (EIR) conducted by the US Food and Drug Administration last month at the company's flagship facility.
The inspection was related to specific extended release applications made from the site. Receipt of EIR confirms the successful closure of the inspections, the company said in a statement.The flagship facility in Bengaluru has capabilities to produce finished dosage formulation products across multiple dosage formats including tablets, capsules, ointments, creams and liquids.
It is also capable of manufacturing complex formulations of extended release tablets which is one of the company's focus areas.
Strides has a large extended release portfolio for the United States and other regulated markets with a capability to manufacture these products at multiple sites.
Strides is a global pharmaceutical company and mainly operates in regulated markets. It has an 'In Africa, For Africa' strategy along with an institutional business to service donor-funded markets.
The company's global manufacturing sites are located in Bengaluru (two locations), Pondicherry, Chennai, Singapore, Milan, Nairobi and Florida. It focusses on 'difficult to manufacture' products that are sold in over 100 countries.
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