Jubilant Pharmova arm Salisbury facility gets USFDA EIR
Noida: Jubilant Pharmova Limited has announced that the Company's subsidiary Jubilant Cadista Pharmaceuticals Inc., USA, (Jubilant Cadista)’s solid oral formulations facility at Salisbury, Maryland, USA has received the Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA).
The inspection for the said Facility was conducted in January 2025.
With the receipt of the EIR from the USFDA, the inspection stands successfully closed.
Going forward, the said Facility is not expected to manufacture any products as it has closed manufacturing operations, as was informed in Company’s previous disclosure.
Voluntary Action Indicated (VAI) classification indicates the inspection found objectionable conditions or practices but the agency has determined the facility can voluntarily correct its deficiencies and will not recommend any action.
Medical Dialogues team had earlier reported that the facility had received five observations with no repeat observations from the USFDA.
Read also: Jubilant Pharmova arm Salisbury facility gets 5 USFDA observations
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.
Read also: Jubilant Pharmova reports significant increase in Q1 net profit to Rs 481.8 crore
