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Full-Spectrum CMO Services
From Molecule to Market-Ready Vial.
Six integrated services. One WHO-GMP facility.
Biochemix offers end-to-end contract manufacturing services for sterile injectables—covering formulation development, aseptic manufacturing, quality testing, regulatory filing, and PCD franchise distribution under one roof.
Years in Manufacturing
Brand Partners
Product SKUs
Batch Pass Rate
Our Manufacturing
Third Party Manufacturing
We manufacture your branded injectable products end-to-end — under your label, to your specifications, with full GMP batch documentation and regulatory traceability.
Pharmaceutical companies across India and export markets partner with Biochemix to leverage our state-of-the-art injectable manufacturing infrastructure without capital investment. Your formulation, our expertise — produced in WHO-GMP compliant facilities with complete batch manufacturing records, CoA, and regulatory support.
All injectable formats
LVP, SVP, Lyophilized, DPI, Cytotoxic, Ophthalmic
Full brand label customization
Your artwork, your registration, your product
Complete batch documentation
BMR, CoA, deviation reports, retention samples
Flexible MOQ
From pilot batches to commercial-scale production runs
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.
Formulation Development & R&D
From API characterization to validation batch, our formulation team develops parenteral formulations with full pharmacopoeial compliance and scale-up readiness.
Our formulation scientists specialize exclusively in injectable dosage forms — aqueous, non-aqueous, lyophilized, and suspension-based parenterals. We use ICH Q8/Q9/Q10 quality-by-design principles throughout development, ensuring your formulation is robust, scalable, and dossier-ready.
QbD-based development
ICH Q8, Q9, Q10 framework with design space definition
Analytical method development
HPLC, UV, GC methods validated per IP/USP
Technology transfer support
Complete documentation package for seamless handover
Lyophilization cycle development
Primary drying, secondary drying, cycle optimization
Quality Control & Analytical Testing
Our NABL-accredited in-house laboratory performs a complete battery of pharmacopoeial tests on every batch. Nothing ships without a signed CoA.
The Biochemix QC laboratory is equipped with HPLC, UV-Vis spectrophotometer, Karl Fischer titrator, osmometer, endotoxin testing apparatus, and automated visual inspection lines. Stability chambers (ICH Zone IVb) support real-time and accelerated studies. All methods are validated per ICH Q2(R1).
Sterility testing
membrane filtration method per IP/USP in isolator-based system
LAL endotoxin testing
kinetic turbidimetric & gel-clot, NABL certified
Particulate matter analysis
light obscuration (HIAC) & visual inspection per IP 2022
Stability programs
ICH-compliant 40°C/75% RH accelerated & 25°C/60% RH real-time
Regulatory Affairs & Compliance
Our regulatory team prepares and files drug dossiers for CDSCO, export registrations, and variation applications — keeping your products compliant across markets.
Navigating India’s pharmaceutical regulatory landscape demands precision and current intelligence. Our RA team brings deep expertise in CDSCO new drug applications, manufacturing license amendments, and export market submissions for GCC, South-East Asia, and African markets.
CDSCO NDA / ANDA filings
complete CTD dossier preparation for Form 44 submissions
Drug Master File (DMF)
API and formulation DMFs for reference in partner filings
Export registration support
GCC, Africa, South-East Asia, ASEAN markets
Post-approval variations
Type I and Type II changes, batch size variation, site transfer
Packaging, Labeling & Cold Chain
From primary glass selection to cold-chain dispatch, we handle every layer of packaging — print-ready labels, serialized cartons, and temperature-monitored logistics.
Packaging is not an afterthought at Biochemix — it is part of the product specification. We source Type I borosilicate glass, LDPE and PP containers, and work with your artwork team for CDSCO-compliant labeling. Batch coding, online inspection, and serialization are integrated in the packaging line.
Type I borosilicate glass
ampoules, vials, and prefilled syringes from validated vendors
Custom label printing
CDSCO-compliant artwork with batch coding, MRP, and serialization
Cold chain dispatch
2–8°C validated packaging for temperature-sensitive injectables
PAN-India delivery
C&F agent network for state-wise distribution to your stockists
How to Engage
Start to Shipment in Four Steps
A transparent, structured process from first enquiry to your product delivered — with a dedicated project manager at every stage.
Testimonials
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.