Labochim HPAPI Kilolab Plant “Led Zeppelin” received cGMP approval
Infa Group is pleased to announce that LABOCHIM SpA has received the cGMP Certification for its new “state of the art” Multipurpose High Potent API plant “Led Zeppelin”.
The AIFA approval is dated 12 October 2015.
The new Kilo Laboratory operates according to cGMP, with a capacity of up to 2.5 Kg/batch size and manufacturing capabilities ranging from a hundred grams to tens of kilograms of both advanced intermediates and APIs, classified from OEB3 to OEB5.
So far, one CDMO product has already been successfully validated and the validation campaign of Tiotropium Bromide will be completed within Q2 2016 at the latest.
About Labochim HPAPI Kilolab “Led Zeppelin”
This investment will further expand INFA’s portfolio of products and services for both the Generic and CDMO segments. This project was conceived and realized with special focus to the highest quality standards while at the same time , offering unique flexibility to Infa customers and therefore, distinguishing Infa Group’s new Multipurpose cGMP HPAPI from all others.
Since the plant was designed to be multipurpose, cytotoxics, betalactams, steroids or other APIs that require a dedicated plant will not be produced in this area. This will ensure no cross contamination with these type of drugs, providing an extremely unique differentiation from other HPAPI providers.
The HPAPI Kilolab Plant is divided in different and distinct areas with completely closed systems guaranteeing a maximum concentration of the products in the environment below < 100 µg/m3 for OEB 3 and below 1 µg/m3 for OEB5 products.
These areas encounter:
The HPAPI Kilolab Plant is divided into separate and dedicated areas:
- R&D/QC Lab Area (QC e R&D) for up to OEB 5 products
- cGMP Production Area for up to OEB 3 products
- cGMP Production Area for up to OEB 5 products , including finishing
- Drying/Finishing cGMP Area for up to OEB 3
About INFA Group HPAPI Strategy
INFA Group has wide and proven experience on APIs for inhalation drugs, being the worldwide leader of Ipratropium Bromide.
In addition, a consolidated portfolio of inhalation APIs grants INFA Group a key position in this ever evolving therapeutic area.
Among the commercial products, INFA Group counts on evergreen products such as Ambroxol, and developed Racepinephrine, Levalbuterol, Clidinium Bromide and others.
Following this consolidated strategy, upon the completion of Tiotropim Bromide validation, several other products in this specific niche shall appear in the INFA Group portfolio.
With ongoing progress on the development of Indacaterol, Vilanterol and Umeclidinium the Generic INFA Group pipeline will further enforce its strong position in the Inhalation field.
The HPAPI Kilolab plant will not be only dedicated to inhalation drugs, as further high potent drugs for COPD and other diseases are and will be handled in the HPAPI Kilolab plant.
This will enable INFA Group an ideal positioning also in the booming market and development of non cytotoxic anticancer drugs.
For a virtual tour in our state of the art “Led Zeppelin” HPAPI Kilolab plant, please visit our website http://infagroup.com/locations/labochim/