Cadila Healthcare, also known as Zydus Cadila, has taken one more step towards augmenting the production capacity for its DNA-based Covid vaccine known as ZyCoV-D by inking an agreement with Shilpa Medicare. Under the agreement, Shilpa Medicare Ltd will use its biologics manufacturing plant at Dharwad, Karnataka, to manufacture ZyCoV-D. ZyCoV-D is the world’s first […]
Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]
Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers. This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India. The approval has been given […]
Cadila Healthcare said it has launched a generic blood thinning medication, Enoxaparin Sodium Injection, in the US, where the drug has annual sales of around $513 mn, or around Rs 3,800 cr. With this, the company has become the first Indian firm to launch a generic version of the drug in that market. Enoxaparin Sodium […]
Cadila Healthcare MD Sharvil Patel said the company has started stockpiling the ZyCoV-D COVID vaccine, and is in the process of providing additional data to drug regulators and hopes to get the shot approved in one or two weeks. If approved, ZyCoV-D will become the first vaccine anywhere in the world to use DNA to […]
Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]
Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]
Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US. The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Fesoterodine is used to treat an overactive bladder with Symptoms of urinary […]
Cadila Healthcare, a Ahmedabad headquartered pharmaceutical company owned by Zydus Group, said it has partnered with Switzerland-based global biopharmaceutical company Neovii to launch an drug to reduce the strength of the body’s immune system in India. The drug named Grafalon is extensively used in solid organ transplants and stem cell transplant, said the company. The […]
Cadila Healthcare said that US FDA has successfully closed an inspection at its facility at Changodar at Ahmedabad. The inspection was carried out in March 2016. The plant makes ointments and is not part of Moraiya formulations manufacturing plant, it said. The receipt of Establishment Inspection Report (EIR) “indicates the successful closure of the inspection […]
