- Active Pharma Ingredients (API)
- Custom Pharma Services (CPS)
- Generics
- Generic Biopharmaceuticals
- New Chemical Entities & Differentiated Formulations
- Contact Us
Capabilities
Infrastructure:
- cGMP E.Coli manufacturing
- cGMP mammalian cell-culture manufacturing
Facility- In accordance with cGMP guidelines; approved by regulatory agencies
- Has the ability to handle most mammalian expression platforms; currently dealing only with products based on CHO cell expression
- 800L: 4 X 200L bioreactor
- One downstream processing train
- Fill-finish with lyophilizer:
Equipped to handle vials (liquid and lyophilized) and pre-filled syringes.
- Vials: 4 million annually (Expandable to 7 million); Volumes: 1 to 50 ml
- Pre-filled syringes: 3 million annually (Expandable to 6 million)
- Lyophilizer: 7 sq. meters
- R&D Center
- Animal facility
- System and expertise in developing biological products of varied complexity
- Proven skills in technology transfer, analytical development and scale-up
- Expertise in regulatory support and filing across key geographies
Designed by