Soon after, Cadila Healthcare received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, the company’s share price rose over 7.9 per cent in early trade on August 23. ZyCoV-D is the world’s first Plasmid DNA Vaccine for COVID-19 and it is scheduled to be launched in September.
ZyCoV-D is a three-dose vaccine administered first on day zero, day 28th and then the 56th day.
With the approval of ZyCoV-D, India got its first COVID-19 vaccine for adolescents in the 12-18 age group. The needle-free vaccine
ZyCoV-D, is administered using The PharmaJet, ensuring a painless intradermal vaccine delivery.
“This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive,” said Pankaj R. Patel, Chairman, Cadila Healthcare.
In another development Zydus Pharmaceuticals Inc, USA (a 100% subsidiary of Cadila Healthcare), has signed a license and supply agreement with CHEMI SpA of Italy, a subsidiary of Italfarmaco Group, to launch the generic equivalent of Sanofi Aventis’s branded product Lovenox (Enoxaparin Sodium Injection) in seven dosage strengths in the United States (US), company said in the release.
As per the agreement, CHEMI would manufacture and supply the Enoxaparin Sodium Injection which Zydus will commercialize in the US.
Also, company has received final approval from the USFDA to market Tofacitinib extendedrelease tablets, 11 mg and 22 mg in the United States. Zydus was the first ANDA filer on Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength, company added in the release.