Services We Offer

1.Formulation Services

• Pancreatin Ready pellets available
• Pancreatin API Available
• Formulations Development Support for(pellets, Capsules, Tablets)
• Dry powder suspension
• Sustained Release Dosage Forms
• Fast dissolving formulations
• Solid dispersions to increase solubility of poorly soluble APIs

2.Analytical Services

• Analytical Method Development for NCE and FFP
• Analytical validation and transfer as per time line
• API and RLD Characterization
• Reverse engineering
• Nitrosamines Development and Validation
• Leachable and extractable studies
• API, Excipients and Drug product compatibility studies
• Diluent compatibility studies
• Photo stability studies
• Stability studies as per ICH Zones
• Freeze-Thaw Stability
• Analytical methods for cleaning validation
• Polymorphism studies
• Dissolution studies
• Forced degradation studies
• Microbiological tests development and validation

3.Impurity Standards

We are supplier and manufacturer of impurity standards. We offer custom synthesis of compounds on request. We provide technical support to your R&D.

Impurity standard certificates contain:

• Description, Solubility, Identification by IR, Mass and 1H-NMR.
• Purity test by either HPLC or GC.
•  Other test like C13- NMR, TGA and potency will be provided on request.
• We offer below services on request basis from grams to multi-kilograms
• Intermediates
• Reference compounds.
• Active Pharmaceutical Ingredients.

Storage and shipment policy

• All impurity standards are stored in a refrigerator at 2 to 8^oC for longer storage period.
• The impurities will be transported to client site at a temperature of below 25^oC.
• For very sensitive impurity standards, special care will be taken by us until it reaches to client site.
• We ship products to clients as per quotation timeline after the order is confirmed.

4. Laboratory Chemicals and Consumables

All laboratory chemicals and consumables will be supplied on request.