Gland Pharma receives EIR from USFDA

Gland Pharma Limited has informed that following the Pre-Market Inspection covering USFDA’s Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) at the Company’s Dundigal Facility at Hyderabad from 22nd August, 2022 to 25th August, 2022; the company has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, USFDA indicating closure of the inspection.

Supriya Lifescience granted Attestation of Inspection for Lote API facility 

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.

Hindustan Unilever completes Nutritionlab acquisition

Hindustan Unilever Limited has completed the acquisition of 19.8% shareholding of Nutritionalab, for a total consideration of Rs. 70 crore in accordance with the terms and conditions of the definitive agreements dated 8th December, 2022. This is in furtherance of the letter dated 8th December, 2022, intimating about the proposed acquisition of shares of Nutritionalab Private Limited, a Private Limited Company incorporated in India. 

Eugia Pharma receives USFDA approval for Azacitidine for Injection

Aurobindo Pharma Limited's wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg Single-Dose Vial. Azacitidine for Injection, 100 mg Single-Dose Vial, to be bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vidaza for Injection, 100 mg Single-Dose Vial, of Bristol-Myers Squibb Company. The product is expected to be launched by this month. The approved product has an estimated market size of around US$ 46 million for the twelve months ending November 2022, according to IQVIA.  This is the 153rd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.