● Qualification and Validation of the facility completed.
● Total working area is ~ 20,000 sqft.
● GMP Sterile Injection Manufacturing :
º Pilot/Pre-exhibit Batches.
º Clinical Supplies (Pilot and Pivotal needs).
º Small scale commercial Batches.
● Manufacturing Capacity :
º Fill Speed:120 vials/min of liquid Products,10 cc vials.
º Batch Size: max at 50 L.
º Lyophilizer Capacity: 5000 x 10 cc vials per cycle.
● Facility design reviewed by US Consultants.
● Registered as 100% Export Oriented Unit.
● Additional Facility of 7500 sqft, totally dedicated for oral formulations, including the containment capability to deal with Cytotoxics.
● Manufacture of Solid orals for clinical supplies or Bio Batches(Pilot and Pivotal).