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SUN PHARMACEUTICAL USFDA
Zaynich's blockbuster potential lifts Wockhardt's long-term outlookWockhardt's novel antibiotic, Zaynich, has received USFDA approval after a 12-year effort, sparking hopes for a turnaround after years of n...
Pharma Q4 outlook mixed: Hospitals steady, generics face revlimid dragIndian pharma and healthcare firms face a mixed March quarter. While hospitals anticipate steady growth, generic drugmakers grapple with lo...
Sun Pharma: How a small Kolkata trader became a global buyout artistSun Pharma, led by Dilip Shanghvi, is poised for its largest overseas acquisition, a $12.5 billion deal for Organon & Co. This move continu...
Sun Pharma arm recalls over 17,000 units of antifungal shampoo in US: USFDATaro Pharmaceutical Industries, a Sun Pharma unit, is recalling 17,664 units of Ciclopirox Shampoo in the US. The antifungal medication is ...
Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violationSun Pharma is recalling 55,000 bottles of Febuxostat Tablets, in 40 mg and 80 mg strengths, from the American market due to manufacturing p...
Sun Pharma recalls around 55k bottles of generic medication in USSun Pharma is recalling approximately 55,000 bottles of a generic medication used to treat bowel disease in the US market. The recall is du...
Sun Pharma, Lupin recall drugs in US market: USFDASun Pharmaceutical is recalling the affected lot that was produced at the drugmaker's Dadra-based facility. The company is recalling the lo...
Sun Pharma, Aurobindo recall drugs from US marketSun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues. Sun Pharma's subs...
Sun Pharma recalls over 24K prefilled syringes of generic medication in the USIn its latest Enforcement Report, the US Food and Drug Administration (USFDA) noted that the Mumbai-based drug major is recalling 24,194 pr...
Sun Pharma, Hetero recall drugs in US marketAs per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or...
Aurobindo, Sun Pharma recall products in US marketWhile Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Phar...
Sun Pharma, Alembic recall products in US marketAccording to industry estimates, the US generic drug market was estimated to be around $115.2 billion in 2019.
USFDA conducting inspection of Mohali plant: Sun PharmaThe inspection by the United States Food and Drug Administration (USFDA) started on September 10, 2018 and is ongoing, Sun Pharma said in a...
Is Sun Pharma's Halol site close to a rebound?About 40% of the US revenues of Sun Pharmaceutical Industries, India's most valuable pharmaceutical company, is linked to its Halol site.
Sun Pharma trades higher after falling 8% in past four sessionsSun Pharma on Wednesday said the US regulator had issued an observation letter after the completion of inspection of its Halol facility.
FDA issues observations post Sun Pharma Halol plant inspectionThe approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plan...
USFDA denies approval for SPARC's anti-glaucoma eyedropSun Pharma Advanced Research Company (SPARC) today said the US health regulator has not approved its new drug application for anti-glaucoma...
Sun Pharma says issues with USFDA at Caraco facility addressedUnited States Food and Drug Administration had conducted inspections in January and May this year and had noticed the lapses.
- Sun Pharmaceutical awaits USFDA approval for cancer drug Lipodox
After gaining market access under a USFDA contingency plan, Sun Pharma is awaiting approval for its cancer drug Lipodox.
- Sun Pharma's US arm resolves issues with health regulator
USFDA had pulled up the US arm of Sun Pharma for violation of manufacturing standards such lack of consistent quality.