Sterile. Compliant. Scalable.

BIOCHEMIX

Biochemix is a state-of-the-art contract development and manufacturing organization (CDMO) specializing in sterile liquid vials, lyophilized freeze-dried powders, and prefilled syringe (PFS) therapies.

Years in Manufacturing
Brand Partners
Product SKUs
Batch Pass Rate
CDSO ISO GMP WHO Aseptic Manufactring DCGI Approved NABL Accredited
CDSO ISO GMP WHO Aseptic Manufactring DCGI Approved NABL Accredited
Extmin DS
Who We Are

Contract Manufacturing Built for Scale

Biochemix is a dedicated third-party injectable manufacturer providing end-to-end production services — from formulation development to batch release — under strict GMP protocols.

Our state-of-the-art facilities handle LVPs, SVPs, lyophilized products, and cytotoxic injectables, manufactured to IP, BP, and USP pharmacopoeial standards with full documentation support.

Our Manufacturing Process

From Formula to Final Vial

A structured workflow ensuring reproducibility, regulatory compliance, and right-first-time quality at every production stage.

Formulation Review

API compatibility, excipient profiling, pharmacopoeial alignment

Raw Material QC

Incoming testing, CoA verification, approved vendor qualification

Aseptic Filling

Grade A fill-finish in validated suites with media fill qualification

Sterilization

Terminal steam, ETO, or filtration per product specification

QC Batch Release

Full analytics, sterility, endotoxin, and authorized batch release

Our Vision & Mission

To deliver high-quality, safe, and affordable pharmaceutical products globally through WHO-GMP and ISO-certified third-party manufacturing, ensuring absolute composition accuracy and innovation.

Awards & Recognition

To maximize partner profitability by eliminating manufacturing investments, utilizing advanced infrastructure, and delivering certified, high-end products that accelerate your brand's market growth.

Manufacturing Capabilities

Six Injectable Platforms. One Facility.

Our integrated manufacturing infrastructure covers the full spectrum of sterile injectable dosage forms, with dedicated lines for each product category in segregated cleanroom environments.

Large Volume Parenterals

IV infusion solutions manufactured in ISO-validated aseptic filling lines with terminal steam sterilization and 100% integrity testing.

Small Volume Parenterals

Ampoules and vials from 1–50 mL filled in Grade A laminar airflow. Automated glass welding and capping for hermetic seals.

Lyophilized Injectables

Freeze-dried powder-for-injection products for temperature-sensitive biologics and oncology drugs requiring enhanced shelf stability.

Dry Powder for Injection

Aseptic filling of sterile dry powder antibiotics and anti-fungals in Grade A environment under nitrogen atmosphere purge.

Cytotoxic Injectables

Dedicated negative-pressure suites with full personnel protection protocols for oncology injectables and chemotherapy formulations.

Ophthalmic Preparations

Sterile eye drops and intraocular formulations in Grade A with 0.22 µm filtration, preservative-free options, and sealed LDPE delivery.

Quality & Compliance

Validated to Every Standard.

Our QA/QC systems are designed to meet the requirements of Indian and international regulatory bodies. Every batch undergoes full analytical testing prior to release.

WHO-GMP

World Health Org · Good Manufacturing Practice

DCGI

Drugs Controller General India · Approved

NABL

Nat'l Accreditation Board for Testing Labs

ISO 9001

International Quality Mgmt System · 2015

Grade A/B Cleanrooms

ISO Class 5 filling zones within ISO Class 7 background environments. Continuous viable and non-viable particle monitoring per environmental monitoring programs.

LAL Endotoxin Testing

Limulus Amebocyte Lysate testing on every parenteral batch. In-house NABL lab performs kinetic turbidimetric and gel-clot methods per IP/USP specifications.

Sterility & Particulate Testing

Membrane filtration sterility testing. 100% automated visual inspection with semi-automated particulate matter analysis per Indian Pharmacopoeia 2022.

Stability Studies & Dossier Support

ICH-compliant accelerated and real-time stability. Full batch documentation, CoA generation, and regulatory dossier support for new product filings and variations.

Biochemix Group Of Companies

bio companies

Testimonials

Working with Biochemic Group from last 13 years, it's really good experience. Compny is very serious for launching new products, which boost up our business

Akshit Sharma

I am doing biochemix past 5 years . Quality service is too Good. Especially Mr.Anuj Sachin, Sm cooperation is very good. Anytime he responds. Good company people.

Raghu Sb

Really good pharmaceutical products, happy to be a business associate. Team is very supportive

Harmandeep Singh

In my opinion Biochemix having highest range of products,,, anything you can find under one roof

Pratibha Mongia

A Really good range of products, Pretty impressed by the quality and the Range

Abhishek Saini
Sterile. Compliant. Scalable.

Ready to Bring Your Next Batch to Market?

Let’s discuss your formulation needs, packaging requirements, and timeline. Partner with Biochemix for hassle-free contract manufacturing.