Indoco Remedies Limited has reported Consolidated financial results for the period ended September 30, 2023.
USFDA conducts pre-approval inspection at Indoco Remedies` Goa facility, issues `four observations`
Indoco Remedies gets EU-GMP certification for Himachal plant
Shares of Indoco Remedies tanked 5 percent in early trade on June 5 after the US Food and Drug Administration tagged the company's Goa facility under the 'Official Action Indicated' (OAI) classification. The OAI status is the most stringent among the three classifications used by the US drug regulator. It is assigned when the regulatory body is dissatisfied with the company's response to the observations issued during the facility inspection.
In little more than a month of US FDA observations for oral formulation facility Plant-I in Goa, Indoco Remedies’ two more units have been issued Form 483 with observations. The company in today’s disclosure to exchanges has informed that its Plant II (Sterile) & Plant III (OSD) units in Goa have received Form 483 with four (4) observations following the GMP inspection conducted from February 20 to 28, 2023.
Indoco Remedies Limited said that the United States Food and Drug Administration (USFDA) examined its AnaCipher Clinical Research Organization in Hyderabad from September 12 to September 16, 2022.
Indoco Remedies Ltd. announced that its clinical research organisation, AnaCipher, located in Hyderabad, was inspected by the United States Food and Drug Administration (FDA) from September 12 to September 16, 2022. The clinical phase of inspection covered three BA/BE studies submitted by clients to the US FDA and was successfully concluded with zero 483s.
Indoco Remedies has entered into a Share Purchase and Shareholder’s Agreement, along with the Power Purchase Agreement to acquire up to 26 per cent stake each in Kanakal Wind Energy and Jalansar Wind Energy for setting up solar power plants at Akkalkot, Solapur district in Maharashtra, a statement from Indoco informed.
Mumbai: Indoco Remedies announced that the US FDA has approved the ANDA Lacosamide injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials. The generic Lacosamide Injection USP of Indoco Remedies is bioequivalent and therapeutically equivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat Injection of UCB, Inc.
Indoco Remedies's Generic Lacosamide Receives Approval in US