The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.
Sajjan India Limited is looking for expansion, both organically and through acquisitions, to achieve the planned growth
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Construction will begin this year with the new capacity anticipated by 2025
Jain will have oversight of Brinton's domestic operations, including business development, sales, and marketing
Subscribe To Our Newsletter & Stay Updated
