HPAPI
Scintel Pharmachem Pvt Ltd has special capabilities in high value-added areas of pharmaceutical development and manufacturing, including High Potency Manufacturing.
Prostaglandins and other highly potent compounds like low volume hormones, steroids and oncology products present a number of potential challenges in their development, production and handling. SPPL has extensive experience in the cGMP production of these types of compounds, from grams to hundreds of kilograms per year.
Facility & Equipment
- Expertise in handling high potency, controlled and generic substances
- Experienced staff dedicated to cGMP synthesis
- Production capacities of facilities ranging from gram-scale through hundreds of Kg.
- Dedicated non-GMP and GMP high-potency areas
- Walk-in hoods and a pilot plant
- Facilities engineered to the most stringent standards for safety, material handling, process control, and efficiency
- Excellent FDA Compliance
- -78° C to 250° C, variety of glass, steel and alloy reactors
- Cryogenic chillers (up to -80°)
- Rotary evaporators
- Reactors ranging from 1Ltr to 500Ltr
- Experience at using reactive & hazardous reagents
- Inaccessible, flexible and well-equipped suite dedicated to small scale manufacturing
- Large-scale preparative chromatography
- Flash Chromatography
- Full-fledged Analytical facility equipped with all modern 21CFR equipments
Bulk Drug APIs
API manufacturing facility is designed to manufacture a variety of APIs and Intermediates using a combination of processes. Our flexible manufacturing infrastructure enables us to expand our product range and change our product mix in response to changes in customer demand and to serve customer requirements ranging from laboratory scale research to commercial production. We have the capability to handle several complex reactions in a cost-effective manner with scale of operations ranging from multiple, multi-product facilities with capacities varying from gram to kilograms and tons. These complex reaction capabilities include cryogenics, cyanation, Silylations, functional group protection, recrystallizations, Organo lithium reactions, enzymatic resolutions, chlorination, carboxylation, hydrogenation, and hydrolysis and organoborane chemistry – across lab-scale, pilot-scale and commercial scale.
Facility & Equipment
- 750 L SS Reactor with Condenser and reflux column
- SS Centrifuge
- 500 L SS Rotary paddle dryer evaporator
- 100kg SS Vacuum Tray Drier
- SS Multimill
- SS Sifter
- 500kg SS Rotocon Blender drier
- Dedicated 0.5mbar oil vacuum pump
- Dedicated watering vacuum pump
- Boiler plant- steam -3tons/hour
- Chiller unit (-15 °c)-100TR
- In-house engineering service
- Full –fledged analytical facility with all modern 21CFR equipments