Indoco Remedies AnaCipher CRO gets clearance on Remote Record Assessment from USFDA
Mumbai: Indoco Remedies has announced that the company's Clinical Research Organisation (CRO), AnaCipher, located in Hyderabad has received clearance on Remote Record Assessment from United States Food and Drug Administration (USFDA).
The Company’s Clinical Research Organisation was inspected by the USFDA in July 2022.
"The USFDA has confirmed that no objectionable conditions were observed during their remote assessment," the company stated in a recent BSE filing.
Commenting on this positive development, Aditi Panandikar, Managing Director, Indoco Remedies Limited, said that “This clearance by USFDA is in continuation to seventh successive FDA inspections which concluded with ZERO 483s for AnaCipher CRO. We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients.”
Read also: Indoco Remedies AnaCipher CRO clears USFDA inspection with Zero observation
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: Indoco Remedies successfully concludes USFDA inspection of CRO Anacipher in Hyderabad
