Formulation development for:
- Tablets
- Capsules
- Pellets (using extrusion-spheronization as well as uidized bed coating)
- Granules to be lled in sachets or stick packs
- Enemas
- Liquid orals
- Dry powder suspensions
Pharmaceuticals
Pharmaceuticals
WE OFFER BELOW SERVICES
Manufacture of clinical trial supplies:
Our pilot plant can manufacture batches up to 100Kg and can be released by our QP for use in clinical or bio-studies which may be conducted in India or in the EU.
ANALYTICAL METHOD DEVELOPMENT
Determining drug purity and uniformity with expertise in chromatography methods of HPLC, GC and other monograph methods.
PRE-FORMULATION STUDIES
Choosing the best excipient by determining the solubility, molecular stability of API and compatibility with various excipients.
FORCED DEGRADATION STUDIES
Gaining a better understanding on the stability of the molecules and using the ndings for Analytical method validations.
FORMULATION DEVELOPMENT
Using principles of Quality by Design and DOE to determine the composition, process development and to optimize the formulation.
TECHNOLOGY TRANSFER
Using the scale up factor approach for transferring technology to inhouse manufacturing site or to any other commercial manufacturing site.
STABILITY STUDIES
Strictly adhering to ICH guidelines and determining the shelf life of a product (40/75, 30/75 and 25/60)
REGULATORY SUPPORT
Developing regulatory strategies for ling of products globally / region specific / country specific and maintaining product lifecycle through best regulatory intelligence practices.
MANUFACTURING CLINICAL BATCHES
The site is proud to have an EU GMP approved small volume tablet manufacturing; including High Shear granulator, Fluid Bed processor, Tablet press and Film Coating equipment to manufacture under class 100,000 tablets for clinical studies & for commercial purpose.
Product List
