The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The newest facility has all the core specialties like Obstetrics and Gynaecology, Orthopaedics, Neurology, Cardiology, Paediatrics, General Surgery, and Urology
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
The training center will focus on providing radiation oncologists, radiotherapy technologists, and medical physicists with the necessary skills
Subscribe To Our Newsletter & Stay Updated
