CMO/CDMO Services

Service Overview

PEC Pharma operates a specialized Contract Manufacturing Organization (CMO) and Contract Development & Manufacturing Organization (CDMO) business vertical. We provide comprehensive solutions for exclusive synthesis, process R&D, tech transfer, and commercial-scale manufacturing.

Our CMO/CDMO vertical supports innovators, formulators, and generic pharma companies with advanced chemistry capabilities — including cryogenic reactions down to -80°C, high-pressure hydrogenations, stereoselective synthesis, and precious metal catalyst handling.

With a technology-driven R&D facility in Vadodara and a multipurpose commercial manufacturing plant in GIDC Saykha, Bharuch, PEC Pharma delivers seamless progression from early-stage CMC design through process validation to commercial supply.

Applications & Services Scope

• Exclusive Synthesis & Custom Chemical Manufacturing for NCEs and complex intermediates
• Process Research & Development (PR&D) — route scouting, optimization, and yield enhancement
• GPCB Approved Reaction Capabilities: Hydrogenation, Chlorination, Bromination, Sulphonation, Nitration, and Amination (Clearance for 712 API & Intermediates)
• Cryogenic & Low Temperature Reactions (down to -80°C and -10°C Brine Chilling)
• High-Pressure Reactions — catalytic hydrogenation, reductive aminations, and autoclave synthesis
• Technology Transfer & Process Validation for global dossier filings (ANDA, ACTD, DMF)
• Scale-up from Kilo Lab (5L–50L) to Multipurpose Commercial Plant reactors (16 KL Total Capacity)
• Chiral Chemistry & Stereoselective Synthesis for enantiomerically pure APIs and building blocks

Why Partner with PEC Pharma for CMO/CDMO

• Pure-play CMO/CDMO vertical with strict IP protection and confidential non-disclosure agreements (NDAs)
• GPCB Environmental Clearance with permissions for 712 Pharmaceutical API & Intermediate products
• Backward integration for key molecules ensuring supply chain security and cost competitiveness
• Versatile plant infrastructure (600 sq. m. G+2 facility with 2,994 sq. m. land for future expansion)
• In-house process safety laboratory generating thermal, gas evolution, and reaction safety data
• Fully equipped utility support including 1 MT Bio-Coal Boiler, 200 TR Cooling Tower, 500 KVA Transformer, and 2-Stage Scrubber System
• Experienced regulatory team providing full cGMP and DMF dossier packages

Manufacturing & R&D Capabilities

Our PR&D setup in Vadodara features state-of-the-art synthetic and analytical laboratories equipped for rapid route scouting and reaction optimization. We utilize Design of Experiments (DoE) methodology to establish robust quality target product profiles (QTPP).

Our kilo lab and pilot facility bridges R&D with commercial production, featuring 5L, 10L, 20L, and 50L glass/SS reactors with operational ranges from -80°C to +200°C. Reaction parameters are systematically evaluated before plant tech transfer.

Commercial CMO/CDMO manufacturing takes place at our GIDC Saykha facility in Bharuch. Plant I comprises a G+2 building (600 sq. m. floor area) with an additional 2,994 sq. m. land reserved for expansion (Plant II). The facility operates a total reaction capacity of 16 KL across GMP Glass-Lined (GMP GLR) and Stainless Steel (GMP SSR) reactors, supported by SS316 centrifuges and a 96-tray drying unit.

Industries & Markets Served

• Innovator pharmaceutical companies outsourcing custom API & intermediate synthesis
• Generic formulation manufacturers seeking backward-integrated supply
• Biotech entities requiring cGMP batch manufacture for clinical trials
• Global partners across LATAM, CIS, SEA, and Africa needing scalable India-based CDMO support
• Specialty chemical and fine chemical companies requiring advanced reaction technology

Technical Specifications & Operating Range

PEC Pharma's CMO/CDMO facility offers versatile technical capabilities and heavy-duty utility infrastructure suited for demanding multi-step synthetic chemistry:

• Reactor capacities: 3 KL to 5 KL Glass-Lined (GMP GLR) & Stainless Steel (GMP SSR) — 16 KL Total Installed Capacity
• GPCB Approved Process Permitted Reactions: Hydrogenation, Chlorination, Bromination, Sulphonation, Nitration, Amination
• Environmental Clearance: 712 Approved Pharmaceutical API & Intermediates
• Filter & Drying: SS316 Centrifuges & 96-Tray Dryer Unit
• Utilities: 1 MT Bio-Coal Fired Boiler, 200 TR Cooling Tower, 40 TR (-10°C) Brine Chiller
• Power & Safety: 500 KVA Transformer, 125 KVA DG Set, 2-Stage Scrubber (5 m³/Hr) & Venturi Vacuum (760 mm Hg)
• ETP & Discharge: Integrated ETP (Bio Reactor, Filter Press) with CETP Saykha Discharge (18 KL/day) & CMEE BEIL Dahej (5 KL/day)

Packaging & Logistics

Custom CMO/CDMO batches are packed in compliance with customer quality agreements and international stability guidelines (ICH). Options include double PE bags inside fiber drums or stainless steel containers with nitrogen blanketing where required.