The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
The inspection classification was determined by the agency as Voluntary Action Indicated
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events
Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR
This product will be manufactured at Lupin's Pithampur facility in India
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
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