Winkem Labs Pvt. Ltd.

Winkem Labs Pvt. Ltd. is a Contract Research, Development and Manufacturing Organization (CRDMO) established in May 2022 by experienced pharmaceutical professionals. The organization provides integrated services including process development, process improvement, manufacturing, and supply services to pharmaceutical industries worldwide.

Core Services

• Chemical Development Services: Complex chemical synthesis, chemical route scouting, specialty chemicals, and process optimization
• Manufacturing & Supply Services: cGMP manufacturing of intermediates, NCEs, and APIs with flexible manufacturing capabilities
• Process Development: KSM and API process development, process optimization, and troubleshooting
• Research & Development Services: Pharma reference standards, impurities, and intermediate synthesis

Facilities & Capabilities

The organization operates across lab, kilo-lab, and industrial scales with modern equipment including:

• 28 reactors with capacities from 5L to 5KL
• 1 cryogenic reactor
• 4 Class 8 clean rooms
• Stainless steel, glass-lined, and all-glass reactor options
• Ancillary systems including cooling towers, chilling plants, centrifuges, tray dryers, and blenders

Quality & Compliance

The organization applies GMP standards from initial stages and maintains established Technology Transfer Protocols (TTP) for process scale-up from pilot to manufacturing plant. Emphasis on Quality & On Time In Full (QOTIF) delivery and sustainable compliance.

Client Base

Serves global leaders and start-ups across 30 countries, with 210 clients and 1,500+ projects completed.