Cadila Healthcare gets US FDA warning letter for Moraiya facility

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 Moraiya plant could face FDA action

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 gets USFDA nod for overactive bladder drug

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 to launch immunosuppressant drug in India

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 says US FDA closes inspection of Ahmedabad ointment plant

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 […]