In the lawsuit filed at the United States District Court for New Jersey, Mayne Pharma accused its rival of violating all 20 Orange Book-listed patents linked to IMVEXXY
Sun Pharma has net cash position of $2.4 bn at end of FY24; 6 new specialty products in R&D pipeline
Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the
Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, as per the US Food and Drug Administration (USFDA). In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said. The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated. USFDA further noted that the company's investigations
The Nifty PCR data suggests that the index may attempt a rally towards 23,700 level ahead of the June series expiry; On the downside, strong support is expected around 23,350 - 23,290.
New York headquartered Taro has operations in the US, Canada, Israel, and Japan with manufacturing facilities in Canada (Brampton) and Israel (Haifa)
Stocks to watch on June 24: USFDA has issued six observations for Cipla's Goa facility following an inspection from June 10 to June 21, 2024
Sun Pharmaceutical Industries on Friday said it has inked a licensing pact with Takeda Pharmaceutical Company to commercialise a novel gastrointestinal drug in India. The company has entered into a non-exclusive patent licensing agreement with Takeda to commercialise Vonoprazan tablets in strengths of 10 and 20 mg in India, the Mumbai-based drug major said in a statement. Vonoprazan is a novel, orally active potassium competitive acid blocker (PCAB), used to treat reflux esophagitis and other acid peptic disorders. "Sun Pharma is a leader in gastroenterology and we are excited to introduce Vonoprazan in India under non-exclusive patent license from Takeda," Sun Pharma CEO - India Business Kirti Ganorkar said. The partnership demonstrates the company's commitment to gastrointestinal health by providing patients and healthcare practitioners with a novel treatment option to manage reflux esophagitis and other acid peptic disorders, he added. Gastroesophageal Reflux Disease (GERD) is
The fall came after the company announced that it has received a warning letter from USFDA for current Good Manufacturing Practice (cGMP) violations at its Dadra facility
Japan's Nikkei declined 0.70 per cent, contrasting with Korea's Kospi which saw a gain of 0.13 per cent. Australia's ASX200 witnessed a marginal decrease of 0.03 per cent
Pharma sector has witnessed a fresh breakout from the consolidation to record high levels and Sun Pharma is offering a fresh buying opportunity
Among individual players, Aurobindo Pharma, Dr Reddys Labs, and Zydus Lifesciences sourced 48 per cent, 47 per cent, and 46 per cent of their total revenues from the US generics segment, respectively
Drug major Sun Pharmaceutical Industries expects a high single-digit top line growth in the current fiscal, according to Managing Director Dilip Shanghvi. The Mumbai-based firm reported a consolidated total revenue from operations at Rs 48,497 crore for FY24. The number stood at Rs 43,886 crore in FY23. "We expect high single-digit consolidated top line growth for FY25. All our businesses are positioned for growth," Shanghvi said in an analyst call. He noted that in the current fiscal, the drug firm will be in the investment phase for its several businesses. "This includes, but not limited to, product launch costs in the US as the ramp-up of our global specialty business is expected to continue," Shanghvi said. He noted that R&D investments will be 8-10 per cent of sales during the year. Replying to a separate query, Shanghvi said: "We have to continue to invest for the future. And our effort would be that while we are creating that investment for future, we don't do it at the ..
Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...
Sun Pharma is in the process of acquiring US-based Taro Pharmaceuticals and taking it private
The management guided for high single digit revenue growth in FY25 factoring in the impact of US site compliance issues.
Firm guides for high single-digit top line, higher R&D spend in FY25; board approves appointment of Dilip Shanghvi as chairman
Sun Pharma Q4FY24 results: The board of the company recommended a final dividend of Rs 5 per equity share of Re. 1 for the financial year 2023-24
Company Results Q4 FY24: Jubilant, Ramco Cements, NIIT Learning also anticipated to release fourth quarter earnings on May 22
At 7:09 AM, GIFT Nifty futures indicated a modest uptick of 25 points, trading at 22,626 against Nifty futures