Indoco Remedies gets OAI status from USFDA for Goa facility

Mumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has determined the inspection classification of the Sterile Facility (Plant II) located at Goa as Official Action Indicated (OAI). OAI means regulatory and/or administrative actions will be recommended.

Medical Dialogues team had earlier reported that the USFDA had inspected the Company's said facility from February 20, 2023 to February 28, 2023 and had issued four observations in Form 483. 

Read also: Indoco Remedies receives 4 USFDA observations for Goa facilities

"The Company is committed towards working with USFDA for remediation of the concerns on highest priority. Further, we believe that this inspection classification will not have an impact on existing supplies or revenues from this Facility," the company stated in a recent BSE filing.

Commenting on the developments, Aditi Panandikar, Managing Director, said that “We have done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe.”

Read also: Indoco Remedies bags USFDA nod for Lacosamide Injection

Headquartered in Mumbai, Indoco Remedies Ltd., is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). The company has 9 manufacturing facilities, out of which, 6 are for finished dosages and 3 for APIs, supported by a state-of-the-art R&D centre at Rabale, Navi Mumbai and a Clinical Research Organisation at Hyderabad. Its manufacturing facilities have been approved by various regulatory authorities such as, USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TMDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, etc.

Indoco offers complete solutions, including product development, manufacture and supply of Finished Dosages, APIs and Intermediates to generic companies worldwide. The company has a large basket of products backed by ANDAs / eCTD Dossiers and Drug Master Files (DMFs).

Read also: USFDA issues EIR for Indoco Remedies Goa facility