Production Capabilities at Oxyneix Lifesciences

At Oxyneix Lifesciences Pvt. Ltd., we specialize in the synthesis and cGMP manufacturing of Active Pharmaceutical Ingredients (APIs), process intermediates, and GMP-grade raw materials. Our facilities are built to accommodate production at every stage — from grams for early-stage discovery to metric tons for commercial supply — enabling a seamless transition through all clinical phases without the need for external technology transfer.

Our integrated setup allows us to manufacture APIs for toxicological evaluation, Phase I–III clinical trials, and commercial-scale supply. With a flexible and scalable infrastructure, we ensure efficiency, quality, and regulatory compliance across the development lifecycle.

Infrastructure and Scale-up Capabilities

We have invested in state-of-the-art infrastructure designed to support both small-scale and full-scale production. Our kilo-scale and pilot-scale labs are fully equipped to carry out cGMP-compliant synthesis from a few hundred grams to tens of kilograms.

Our core capabilities include:

• 10 dedicated production blocks with 11 clean room zones, supporting an annual production capacity of over 1500 metric tons

• 136 reactors with a combined reactor volume of approximately 650 KL

• Reactor capacities ranging from 100 liters to 16 MT, including glass-lined and stainless-steel reactors

• Expertise in handling high-pressure reactions, complex organic transformations, and multi-step synthesis

• Fully integrated utilities and automated controls for precision and reliability.

Certifications and Compliance

Our manufacturing site meets global regulatory standards:

• Inspected and approved by EDQM and Cofepris (Mexico)

• WHO-GMP certified and ISO 9001:2015 compliant

• Site prepared for USFDA inspection

• Strict material and personnel movement protocols to ensure cross-contamination and mix-up prevention

Whether it’s a highly potent compound, a complex molecule, or a first-in-class intermediate, we bring chemical and biocatalysis expertise to every synthesis project. Our rapid scale-up systems allow for quick turnaround in preparing reference standards, impurity markers, and intermediates, ensuring efficiency at every level.

Advanced Quality Control Laboratory

At Oxyniex, we place the highest emphasis on product quality, safety, and consistency. Our in-house Quality Control Laboratory is equipped with advanced instrumentation to perform comprehensive analysis across every batch.

Key Analytical Capabilities Include:

Chromatography

• HPLC (High-Performance Liquid Chromatography)

• UPLC (Ultra Performance Liquid Chromatography)

• GC (Gas Chromatography)

• GC with Headspace Analyzer

Spectroscopy

• FT-IR (Fourier-Transform Infrared)

• UV-Visible Spectrophotometer

• ICP-MS (Inductively Coupled Plasma Mass Spectrometry)

• Microwave Digestion Unit

Particle and Physical Analysis

• Malvern Mastersizer for Particle Size Distribution

• Microscopy Suite

• Bulk and Tap Density Analyzer

• pH Meter, Turbidity Meter, and Moisture Analyzer

• Melting Point Analyzer

Microbiological & Wet Chemistry

• Autoclave, Incubator, and Bio-safety Cabinet

• Colony Counter, Anaerobic Culture Jar

• Fogger Machine and Air Sampler

• Conductivity and TDS Analyzers

• Stability Chambers (ICH compliant)

Other Instrumentation

• Polarimeter, Mass Detector, LOD & Vacuum Ovens

• Milli-Q Water Purification System

• Ultrasonic Bath

• Glassware Drying Oven

• Muffle Furnace

At Oxyneix Lifesciences, we combine global standards, cutting-edge infrastructure, and deep technical know-how to deliver reliable, scalable, and compliant API solutions tailored to your needs.