Cytotoxic and targeted therapy formulations manufactured in dedicated high-potency API (HPAPI) facilities with specialized containment, validated cleaning procedures, and strict safety protocols for oral and injectable dosage forms
Dedicated high-potency API manufacturing capabilities for cytotoxic and targeted oncology therapies with rigorous containment and safety controls
Our oncology portfolio includes 80+ chemotherapy and targeted therapy formulations manufactured in dedicated HPAPI facilities with occupational exposure limits (OEL) <1 μg/m³. Utilizing containment technology (isolators, RABS), negative pressure manufacturing areas, and validated cleaning procedures, we ensure operator safety and prevent cross-contamination.
All oncology products undergo potency testing, sterility testing (for injectables), particulate matter analysis, and stability studies under refrigerated conditions (2-8°C) where required, meeting the strictest international quality and safety standards.
Specialized high-potency containment process ensuring operator safety, product quality, and regulatory compliance at every stage
High-potency active pharmaceutical ingredients are weighed and dispensed inside validated isolators to prevent operator exposure and cross-contamination.
Formulation and blending take place in a dedicated oncology-only manufacturing suite maintained under negative pressure to contain hazardous particulates.
Injectable oncology formulations are aseptically filled under Grade A laminar airflow within isolators to maintain sterility and full containment.
Equipment and facility cleaning is validated to residue limits below 10 ppm, preventing cross-contamination between oncology and other product lines.
Finished products are packaged with prominent cytotoxic hazard labeling, secondary containment, and personnel environmental monitoring before release.
Specialized HPAPI manufacturing environment and safety controls for oncology formulations
Dedicated HPAPI suite maintained under negative pressure with segregated air handling
OEL <1 μg/m³ maintained throughout handling and manufacturing
Isolators and RABS (Restricted Access Barrier Systems) for all powder handling
Tested per USP <71> for all injectable oncology formulations
95-105% of labeled amount, verified through rigorous batch testing
Many oncology formulations require 2-8°C cold-chain refrigeration
Comprehensive oncology portfolio across major cancer types and treatment modalities
Multiple packaging options designed for product protection and market compliance
Amber glass vials with prominent cytotoxic hazard labeling and tamper-evident seals for injectable oncology products.
HDPE bottles with child-resistant closures and cytotoxic warning labels for oral chemotherapy products.
Additional protective outer packaging ensuring safe handling and transport of hazardous cytotoxic drugs.
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