Sun Pharmaceutical launches phenobarbital sodium injection in US, Health News, ET HealthWorld

New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday launched its phenobarbital sodium injection, SEZABY for the treatment of neonatal seizures in the US. SEZABY is the first and only product approved by the US Food and Drug Administration (USFDA) for the treatment of neonatal seizures in term and preterm infants, Sun Pharma said in a regulatory filing. It is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. “The launch of SEZABY is an exciting addition to our growing portfolio of specialty branded products in the…

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USFDA pulls up Sun Pharma for lapses in Halol plant, Health News, ET HealthWorld

The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. “This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals… Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP,…

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Pricing pressures, regulatory overhang affect margins of Indian pharma cos in FY2023: ICRA, Health News, ET HealthWorld

Mumbai: ICRA Limited, an investment information and credit rating agency sees that the pricing pressures, regulatory overhang affect margins of Indian pharma companies in Financial Year 2023. It expects the revenues of Indian pharmaceutical companies to grow by four to six per cent in FY2023, marginally lower than the growth of about 7.7 per cent in FY2022. For FY2024, ICRA expects the sample set revenues to grow by six to eight per cent, primarily driven by the domestic and emerging markets. This came about with ICRA’s sample set of 16…

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USFDA issues warning letter to Glenmark for lapses at Goa plant – ET HealthWorld

New Delhi: The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company’s Bardez-based facility in Goa, which produces drug formulations. The US Health regulator noted that the “warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.” It further said:…

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Dr Reddy’s, Sun Pharma recall products in US for manufacturing issues – ET HealthWorld

New Delhi: Drug majors Dr Reddy’s Laboratories and Sun Pharma are recalling different products in the US market for manufacturing issues, according to the US Food and Drug Administration. As per the enforcement report by the US health regulator, the US-based arm of Dr Reddy’s Laboratories is recalling over 48,000 cartons of a drug used to treat sneezing, runny or stuffy nose. It is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets. According to USFDA, Dr Reddy’s Laboratories is recalling the affected lot due to “failed…

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Takeda’s BLA for ‘TAK-003’, dengue vaccine candidate gets priority review by FDA – ET HealthWorld

Mumbai: Takeda announced that the US Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate. In the US, TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age. Dengue is a mosquito-borne virus endemic in more than 125 countries, including the US territories of Puerto Rico, the US Virgin Islands and American Samoa. Incidence of dengue has increased globally…

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USFDA asks Panacea Biotec to take corrective measures at Himachal unit – ET HealthWorld

New Delhi: Panacea Biotec Ltd on Thursday said the US health regulator has asked for further corrective actions at the manufacturing unit of its wholly-owned arm at Baddi in Himachal Pradesh otherwise approval of any pending product applications from the facility may be withheld. The US Food and Drug Administration (USFDA) inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma Ltd (PBPL) from May 30 to June 8, 2022. Subsequently, the USFDA issued Form 483 with eight observations which are related to improvements in existing procedures and are addressable,…

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Bayer launches Finerenone medication for CKD patients with type 2 diabetes – ET HealthWorld

Mumbai: Bayer Pharma announced the launch of Finerenone under the brand name Kerendia, first-in-class non-steroidal, selective mineralocorticoid receptor antagonist indicated for patients with Chronic Kidney Disease (CKD) associated with type 2 diabetes. Manoj Saxena, Managing Director, Bayer Zydus Pharma said “Finerenone offers a new treatment approach for the vulnerable patients to slow down the progression of CKD and reduce the risk of kidney failure. It can also reduce the risk of heart disease associated with chronic kidney disease. Additionally, the economic burden of dialysis or renal transplant required for kidney…

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Drug makers Glenmark, Sun Pharma, Dr Reddy’s recall products in US – ET HealthWorld

New Delhi: Leading generic drug makers Glenmark, Sun Pharma, Dr Reddy’s and Jubilant Cadista are recalling multiple products in the US market, the world’s largest market for medicines, for various issues. As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Mumbai-based drug firm Glenmark is recalling over 6.5 lakh tubes of a generic skin treatment ointment due to manufacturing issues. New Jersey-based Glenmark Pharmaceuticals Inc, a subsidiary of the company, is recalling affected lot of Tacrolimus Ointment, which is used to treat eczema, due to…

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Aurobindo Pharma AP unit gets 3 USFDA observations – ET HealthWorld

New Delhi: Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and…

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