API Manufacturing - Scintel Pharma

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.

State of The Art High Potency Manufacturing Suites Include:

Class 100000 Clean Room

cGMP-Compliant Glove Box Isolators

cGMP –compliant bio safety cabinets

Walk- in Fume Hoods

Bench Top Fume Hoods

Reactors Capable of Handling Materials With OELs Under 1 ug/m3

Manufacturing capabilities up to 500 liter reaction scale with batch sizes of 50-100 kg

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.