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Why Is USFDA Inspecting India Pharma Firms?

Kindly note the image has been posted only for representational purposes.Photograph: Kind courtesy Pixabay.com   The Indian pharmaceutical industry's recent tryst with the US drug regulator......

Covovax as Covid booster jab to be available on CoWIN soon

In view of rising cases of COVID-19 in various parts of the country, Union Health Minister Mansukh Mandaviya is learnt to have approved the inclusion of Serum Institute's Covovax on the CoWIN......

India probes eye drop linked to vision loss in US

A day after its plant was inspected by Indian drug regulatory bodies over allegations that its eye drop was linked to vision loss in the United States, Tamil Nadu-based Global Pharma Healthcare has......

USFDA denies Covaxin emergency use nod, to take 'full approval' route

In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the......

Explained: What USFDA full approval to Pfizer-BioNTech vaccine means

Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das. IMAGE: Vials......

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse......

Pricing challenge in US biz, rich valuations may weigh on pharma stocks

The tailwind of low price erosion in the US generics market, seen by domestic pharmaceutical companies in calendar year 2023 (CY23), may be reversing slowly, caution analysts. Illustration: Uttam......

'Depending on the product, the pricing pressure will always be there'

'From an Indian pharma sector's perspective, we are probably the only company that has a substantial presence in the specialty segment in the US and globally.' Photograph: Kind courtesy Sun Pharma......

Quality Lapses Shut Down Drug Makers

Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories. IMAGE: Kindly note the image has been posted only......

Weak Q4 may be rare bitter pill for Sun Pharma

Sun Pharmaceutical Industries reported a 34 per cent year-on-year (Y-o-Y) jump in net profit to Rs 2,654.6 crore in Q4FY24. Photograph: Francis Mascarenhas/Reuters The company’s Ebitda......

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