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Articles for Regulatory

Zydus Gets Final Nod For An Antibacterial Drug From USFDA

Ahmedabad-based Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Erythromycin Tablets USP, 250 mg and 500 mg a generic equivalent of US reference listed drug, Erythromycin Tablets

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Zydus Receives Approval From USFDA For Isotretinoin Capsules

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India)

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Glenmark Pulls Back 1,200 Bottles Of Hypertension Drug From US

As per the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals is in the process of recalling 1,200 bottles of a generic drug which is used in the treatment of high blood pressure, in the US market due to a manufacturing fault

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Gland Pharma Gets 2 Observations On Form 483 In A Pre-market Inspection By USFDA

Gland Pharma informed that the USFDA inspected the Pashamylaram Facility at Hyderabad from 23 August 2023 to 26 August 2023

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Lupin Receives Approval From USFDA For Pirfenidone Tablets

The drug is indicated to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). As per the company's statement, this product will be manufactured at Lupin’s Pithampur facility in India

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CDSCO Flags 51 Drugs In July Alert From Cipla, Sun Pharma, Alkem Health Science & Others

In the latest drug alert for the month of July, the Central Drug Standard Control Organisation (CDSCO) has flagged as many as 51 drug formulations from top pharma giants such as Cipla, Sun Pharma and Alkem Health Science among others.

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Ipca Labs Piparia Facility Receives VAI Status From FDA

Ipca Laboratories on Thursday informed the exchanges that its Piparia (Silvassa) formulations manufacturing facility has received the status "Voluntary Action Indicated (VAI)" from USFDA after the regulator had conducted an inspection on the unit from 18th April 2023 to 26th April 2023.

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Torrent Pharma's Dahej Facility In Gujarat Gets EIR From USFDA

On Thursday, Torrent Pharmaceuticals informed in an exchange filing that it has received the green light from USFDA for its manufacturing facility in Dahej, Gujarat. The manufacturing site was inspected by the USFDA from 17-May-23 to 25-May-23

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