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USFDA inspection

Lupin gets FDA green signal for Mandideep facility; shares rise

Lupin gets FDA green signal for Mandideep facility; shares rise

Wed, Nov 01, 2023

Lupin shares were in demand on Wednesday after the drug maker received an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for its manufacturing facility in Mandideep, Madhya Pradesh.

Sun Pharma recalls 2.7 lakh bottles of antidepressant in US

Sun Pharma recalls 2.7 lakh bottles of antidepressant in US

Sun, Feb 05, 2017

The recall is being initiated by Sun Pharmaceutical Industries Inc for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Divi's Laboratories report 9% rise in net profit in Q3

Divi's Laboratories report 9% rise in net profit in Q3

Sat, Feb 04, 2017

Updating on US-FDA inspection, Divi's Lab said, "It has filed its comprehensive response to the observations of the FDA regulator within the stipulated time. Now it awaits for review from the US pharma regulator.

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Pharma Q3: FDA inspection, US pricing market key

Pharma Q3: FDA inspection, US pricing market key

Thu, Jan 12, 2017

Piyush Nahar and Anurag Mantry analysts of Jefferies said, “We expect another muted quarter for the pharma sector led by weakness in US business. USFDA inspections and pricing in US market will continue to dominate the results. Recent comments from global peers have indicated that pricing scenario will likely remain unchanged in 2017.”

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