Zydus Cadila proposes US$ 25 for needle-less Covid-19 vaccine

INDIA – Indian drugmaker Zydus Cadila has proposed pricing for its three-dose Covid-19 vaccine ZyCov-D jab that can be given to those above 12 years of age at US$ 25.6 (Rs 1,900), inclusive of taxes. However, the central government is negotiating a price reduction, with a final decision expected this week. Negotiations are still underway and the firm has been urged to examine all aspects of the vaccine’s pricing. A final decision on the vaccine’s pricing is expected this week. ZyCoV-D is expected to be priced differently from Covaxin and…

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Cadila sells two of its brands as Glenmark bags USFDA nod for generic antibiotic cream

INDIA – Cadila Healthcare has announced that its subsidiary has inked a pact with Integrace Private Limited to sell two brands, Mifegest and Cytolog at an undisclosed amount. Zydus Healthcare Ltd, a wholly-owned subsidiary of the company, has inked the agreement with Integrace, a part of the portfolio companies of private equity firm True North. “The said transaction is expected to be completed within 30 days from the date of execution of agreement, subject to customary approvals,” Cadila Healthcare said in a regulatory filing. Meanwhile, Cadila’s competitors Glenmark Pharmaceuticals has…

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Zydus Cadila gets US-FDA nod for antidepressant drug

INDIA – Zydus Cadila received final approval from the US Food Drug Administration to sell new generation anti-depressant Vortioxetine in the strengths of 5 mg, 10 mg, 20 mg in US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Vortioxetine works by increasing serotonin in the brain by preventing the elimination and reuptake of seratonin in the brain, and is classified as a selective serotonin reuptake inhibitor and serotonin receptor modulator. Zydus has been on a…

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Zydus Cadila gets USFDA’s approval to market diabetes medication

INDIA – Drug firm Zydus Cadila has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes. The company said its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets. On October 31, 2020, Zydus had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets. The NDA received tentative approval upon completion of…

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Dr Reddy’s, Zydus recall products in US market as Bharat seeks out vaccine partners

USA – Leading drug makers Dr Reddy’s Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy’s Laboratories, Inc, the US arm of Dr Reddy’s Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said. The tablets are manufactured by Dr Reddy’s Laboratories Ltd at its Srikakulam facility, it added. They are used to treat…

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Zydus Cadila’s COVID-19 vaccine to be available from first week of October

INDIA – The Union government is expecting Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D to be available from the first week of October. Further, a decision on whether all children or only those with co-morbidities will be administered the COVID-19 vaccine on priority has not yet been taken, the government said. Indigenously developed Zydus Cadila’s ZyCoV-D on Friday received approval for Emergency Use Authorisation from the drug regulator, making it the first vaccine in the country which would be administered in the age group of 12-18 years. On the kind of…

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Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity

INDIA – Drug firm Zydus Cadila has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market. The company said it has received approval from the US Food and Drug Administration (USFDA) for the drug in 11 mg and 22 mg strengths. Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength, the company said in a statement. Arthritis, or joint disease, is inflammation…

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Aurobindo Pharma, Cadila, 3 others in race to acquire Sterling Biotech

INDIA – Aurobindo Pharma, Cadila Healthcare, UPL and two other companies are in the fray to acquire bankrupt Sterling Biotech Ltd. through the liquidation process. The other two companies in the race are ACG Associated Capsules and Gland Celsus Bio Chemicals. Last month, the liquidator had invited bids for the liquidation process of Sterling Biotech to sell it as a going concern at a reserve price of Rs 548.46 crore. Lovkesh Batra, a member of the Mamta Binani-led liquidation team told media that the shortlist of entities looking to acquire…

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India grants approval to ZyCoV-D, first ever DNA based COVID-19 vaccine

INDIA – The world’s first DNA-plasmid vaccine, the three-dose one for Covid-19 developed by Cadila Healthcare (Zydus Cadila), has received emergency-use authorization from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above. “It is a matter of great pride that today we have EUA for the world’s first DNA Covid-19 vaccine, ZyCoV-D, by Zydus, developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha,” Renu Swarup, secretary, department of biotechnology, and chairperson, Biotechnology Industry Research Assistance Council, said. This…

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Zydus Cadila anticipates emergency use approval for its COVID-19 vaccine

INDIA – In what will be the first COVID-19 jab for the adolescent population in India, the Zydus Cadila vaccine expects to get a nod from the Indian regulatory centre this week. Zydus Cadila’s jab will be the sixth COVID-19 vaccine to get approved in India after Covishield, Covaxin, Sputnik V, Moderna and J&J, which was the latest to get DGCI approval. ZyCoV-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. It can be stored at 2-8 degree Celsius but has shown good stability at…

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