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US FDA had inspected Aurobindo Pharma's Unit VII from May 2, 2022 to May 10, 2020 and had issued six observations.
Unit-VII is Aurobindo Pharma's oral manufacturing facility situated at Jedcherla, Hyderabad. It is ultra-modern unit based on the suite manufactu…
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USFDA closes warning letters for three sites of Dr Reddy's Laboratories | Pharma News
In November 2015, the company said it had received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites -- acti…
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Dr Reddy's Labs Gets USFDA EIR For Srikakulam Formulations Plant | Pharma News
Hyderabad: Dr. Reddy's Laboratories Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug …
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USFDA clears four Indian manufacturing plants in 10 days | Pharma News
MUMBAI: India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (…
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FDA encourages recovered patients to donate plasma for development of blood-related therapies | Pharma News
As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners acr…
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FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis | Pharma News | FDA
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the h…
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USFDA retains OAI status for Indoco's Goa plant | Pharma News | FDA
As per the USFDA, observations have been made after inspection of a facility in response to Form 483. An FDA Form 483 notifies the company's man…
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