Manufacturing Facility - Pilot and Production Batches

● 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.

Solid Orals Development & Manufacture

● 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).