Cipla arm New York facility gets EIR from USFDA
Mumbai: Cipla has announced that the New York manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company, has received the EIR (Establishment Inspection Report) from the US Food and Drug Administration (USFDA) on the classification of the inspection as Voluntary Action Indicated (VAI).Voluntary action indicated (VAI), means objectionable conditions...
Mumbai: Cipla has announced that the New York manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company, has received the EIR (Establishment Inspection Report) from the US Food and Drug Administration (USFDA) on the classification of the inspection as Voluntary Action Indicated (VAI).
Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
The USFDA had inspected the facility from 11th September, 2023 to 19th September, 2023 and issued five inspectional observations.
Read also: USFDA issues 5 observations to Cipla US arm
"In furtherance to intimation dated 20th September, 2023 for United States Food and Drug Administration (USFDA) inspection at the manufacturing facility of InvaGen Pharmaceuticals Inc., wholly owned subsidiary of the Company (“InvaGen) located in Central Islip, Long Island, New York, USA, we hereby notify that the Company has received the EIR (Establishment Inspection Report) from the USFDA on the classification of the above-referred inspection as Voluntary Action Indicated (VAI)," Cipla informed in a recent BSE filing.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai.
The Company specializes in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 47 manufacturing sites worldwide produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 86 markets.
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