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…

Read More

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,…

Read More

US FDA lists Sun Pharma’s Halol unit under ‘import alert’ – ET HealthWorld

Mumbai: The United States Food and Drug Administration (US FDA) has placed Sun Pharmaceuticals’ Halol unit under ‘import alert‘. This implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with cGMP standards. The US FDA inspected Sun Pharma’s Halol unit from April 26 to May 9, 2022. The US FDA has excluded 14 products from this import alert subject to certain conditions. The company said that supplies to the US market from the…

Read More

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…

Read More

Sun Pharma inks licensing pact with SPARC to commercialise medication in US market – ET HealthWorld

Mumbai: Drug major Sun Pharma on Wednesday said it has inked a licensing agreement with Sun Pharma Advanced Research Company to commercialise a medication for the treatment of neonatal seizures in the US market. The Mumbai-based drug maker has inked a pact with Sun Pharma Advanced Research Company (SPARC) to commercialise benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the US. SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for the said product in February 2022. Currently, there are…

Read More

Q2 Results: Sun Pharma Sales Up By 10% YoY, Records Net profit Of 2,262 Cr

The company’s sales in India saw a jump of 8.5 per cent to Rs 3,460 crore, a rise of 8.5 per cent against the second quarter of last year. At the same time, the sales in the US were up by 27.5 per cent quarter on quarter and stood at USD 200 million The Indian pharmaceutical giant Sun Pharma reported its quarter two earnings on Tuesday, the pharma major has recorded gross sales worth of Rs 10,809 crores for the quarter that ended in September 2022, a 13.1 per cent…

Read More

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…

Read More

Sun Pharma expands tie-up with Cassiopea for acne cream to six countries – ET HealthWorld

Sun Pharmaceutical Industries on Tuesday said it has expanded the scope of its partnership with Cassiopea regarding a medication to treat acne. It has inked addendums to the licence and supply agreements for WINLEVI (clascoterone) cream 1 per cent, expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia. As per the tie-up, the company will receive from Cassiopea the exclusive right to develop and commercialise WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia, Sun Pharma said in a statement. Cosmo will be the exclusive…

Read More

Top diabetic drug goes off patent, prices to fall by 3rd – ET HealthWorld

MUMBAI: In good news for diabetics, cheaper versions of a blockbuster drug — Januvia (Sitagliptin) — hit the market on Wednesday, with more expected soon. The growing anti-diabetes market, valued at about Rs 17,000 crore, is set to witness action with generic versions of US firm Merck’s blockbuster Januvia being launched, reducing the cost of therapy by a third. This is on the heels of Sitagliptin, a relatively newer but vital anti-diabetic drug, losing patent protection in July. Importantly, the drug’s generic versions are expected to be priced in the…

Read More

Generics of MSD diabetes pill set to flood market as patent expires – ET HealthWorld

The oral anti-diabetes drug market is in for a major shake-up as Merck, Sharp & Dohme’s (MSD‘s) Januvia is expected to go off patent this month. According to market research firm AIOCD, at least 50 Indian drug makers are jumping into the fray with around 100 generic versions of the popular anti-diabetes medication, leading to a likely price war. Analysts expect prices to drop by 60% with the entry of generics, and intensify competition for vildagliptin and teneligliptin, two molecules of the same class that went off-patent in 2019 and…

Read More