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Articles for Regulatory

Lupin Gains Tentative FDA Approval For Apalutamide Tablets

The Apalutamide Tablets, 60 mg will be manufactured at Lupin’s Pithampur facility in India, the company's statement informed.

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US FDA Issues Nine Observations To Dr Reddy's Hyderabad Manufacturing Site

On Thursday the US Food & Drug Administration (USFDA) issued 9 observations for Dr Reddy's biologics manufacturing facility at Bachupally in Hyderabad

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DCGI Gives Six-month Extension To Medical Device Makers For Licensing Compliance

DCGI in the letter said that the government had notified manufacturers in February 2020 giving a deadline of 42 months ending on October 01 2023 for all medical device makers making Class C and D products

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Indian Regulator Allows Firm Linked With Cough Syrup Deaths To Re-open Factory

India's northern state of Uttar Pradesh has permitted the resumption of most production at a factory owned by Marion Biotech, which produced cough syrups Uzbekistan linked to the deaths of 65 children last year, an order seen by Reuters shows

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WHO Releases Roadmap To Tackle Deaths Caused By Postpartum Haemorrhage

PPH defined as excessive bleeding after childbirth affects millions of women annually and is the world’s leading cause of maternal deaths resulting in around 70,000 deaths every year.

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SC Asks Centre, States Regarding National Initiative To Address Muscular Dystrophy

On Friday the Supreme Court called for responses from the Centre, AIIMS, and all Indian states in response to plea filed by 251 children afflicted with muscular dystrophy.

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Biocon Biologics Receives Complete Response Letter From USFDA For Biosimilar Insulin Aspart

On Saturday Biocon in an exchange filing said that the U.S. Food and Drug Administration (US FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for insulin Aspart

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1 In 10 Babies Born Prematurely Worldwide: WHO

A recent study by WHO on Friday revealed an estimated 13.4 million babies were born early (before 37 full weeks of pregnancy) in 2020 which is around 1 in 10 of all live births.

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