Zydus Lifesciences gets zero USFDA observations for Moraiya facility
Ahmedabad: Zydus Lifesciences Limited has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection with zero observations at the company's manufacturing facility at Moraiya, Ahmedabad.
The inspection was held from 23rd to 27th January, 2023.
"We wish to inform that the USFDA conducted an inspection at the manufacturing facility of Zydus Lifesciences Limited located at Moraiya, Ahmedabad from 23rd to 27th January, 2023. The inspection was a Pre-Approval Inspection (PAI) for Transdermal Patch products," the company stated.
Medical Dialogues team had earlier reported that Zydus Lifesciences Ltd. had received an Establishment Inspection Report (EIR) from the USFDA for its formulations manufacturing facility in Moraiya, near Ahmedabad, India.
Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
The group has manufacturing capabilities across the entire pharmaceutical value chain: including formulations, APIs, vaccines, biosimilars, complex products (transdermals, topical etc.), animal health products, and wellness products.