Drug Approval | September 05, 2023
Caplin Steriles receives EIR from US FDA
The inspection classification was determined by the agency as Voluntary Action Indicated
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
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
The approval bolsters the company's Mycophenolate Mofetil portfolio
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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