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.
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.
A structured workflow ensuring reproducibility, regulatory compliance, and right-first-time quality at every production stage.
API compatibility, excipient profiling, pharmacopoeial alignment
Incoming testing, CoA verification, approved vendor qualification
Grade A fill-finish in validated suites with media fill qualification
Terminal steam, ETO, or filtration per product specification
Full analytics, sterility, endotoxin, and authorized batch release
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.
To maximize partner profitability by eliminating manufacturing investments, utilizing advanced infrastructure, and delivering certified, high-end products that accelerate your brand's market growth.
Our integrated manufacturing infrastructure covers the full spectrum of sterile injectable dosage forms, with dedicated lines for each product category in segregated cleanroom environments.
IV infusion solutions manufactured in ISO-validated aseptic filling lines with terminal steam sterilization and 100% integrity testing.
Ampoules and vials from 1–50 mL filled in Grade A laminar airflow. Automated glass welding and capping for hermetic seals.
Freeze-dried powder-for-injection products for temperature-sensitive biologics and oncology drugs requiring enhanced shelf stability.
Aseptic filling of sterile dry powder antibiotics and anti-fungals in Grade A environment under nitrogen atmosphere purge.
Dedicated negative-pressure suites with full personnel protection protocols for oncology injectables and chemotherapy formulations.
Sterile eye drops and intraocular formulations in Grade A with 0.22 µm filtration, preservative-free options, and sealed LDPE delivery.
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.
World Health Org · Good Manufacturing Practice
Drugs Controller General India · Approved
Nat'l Accreditation Board for Testing Labs
International Quality Mgmt System · 2015
ISO Class 5 filling zones within ISO Class 7 background environments. Continuous viable and non-viable particle monitoring per environmental monitoring programs.
Limulus Amebocyte Lysate testing on every parenteral batch. In-house NABL lab performs kinetic turbidimetric and gel-clot methods per IP/USP specifications.
Membrane filtration sterility testing. 100% automated visual inspection with semi-automated particulate matter analysis per Indian Pharmacopoeia 2022.
ICH-compliant accelerated and real-time stability. Full batch documentation, CoA generation, and regulatory dossier support for new product filings and variations.
Let’s discuss your formulation needs, packaging requirements, and timeline. Partner with Biochemix for hassle-free contract manufacturing.