Regulatory Capabilities & Achievements

In-house Capabilities
Proficiency in developing analytical methods (HPLC & GC)
Capability to validate analytical methods
Synthesize and Characterize impurities and Working Standards
Understanding of IPR & Regulatory Criteria for example developing non infringing route of synthesis,
different polymorphism etc.
In-house interpretation of NMR, LCMS etc.

Achievements
One PCT filed for a novel and cost effective synthesis of an intermediate of Clopidrogel (Ref. No. PCT/IN04/00193)
Few Provisional Patents under filing
EDMF's prepared for two products (Mebeverin & Lmaotrigine)
DMF's submitted to UK MHRA, French National Authorities etc.

Equipment
Block-1 - Equipped with 2kl SS & GLR reactors, 36" 4point cGMP compliant Centrifuge, RVD (1 kl), Multi-mill and Sifter (150-200 kg output batch size)
Block-2 - Equipped with 2 kl SS & GLR reactors, 36" 4 point cGMP compliant Centrifuge, FBD, Octagonal Blender, Multi-mill and Sifter (250-300 kg output batch size)
Block-3 - (Pilot Block): Equipped with 500 kl SS & 630ltr GLR reactors, 24" 4 point cGMP compliant Centrifuges, Octagonal Blender, Vacuum Tray Drier (12 trays), Multi-mill and Sifter (25-50 kg output batch size)

Air Handling System In each block the reactor area would be 100% once through ventilation system
(5 micron filters with facility to add 0.2 micron filter in the plenum)
In each block the Powder Processing area would be recirculation system
(5micron filters with facility to add 0.2 micron filter in the plenum)
Appropriate Pressure Differential between rooms/ operations Civil, Doors, Windows, Flooring etc. & Other Requirements
As per cGMP guidelines