Sterile pharmaceutical injectables manufactured in Grade A cleanrooms with aseptic filling technology, lyophilization capabilities, and PIC/S certified facilities for vials, ampoules, and pre-filled syringes
Comprehensive sterile injectable manufacturing capabilities across major therapeutic categories with aseptic precision and uncompromising quality assurance
Our injectable portfolio encompasses 150+ formulations manufactured under stringent aseptic conditions in Grade A cleanrooms (ISO 5) within Grade B background (ISO 7). Capabilities include terminal sterilization (autoclaving), aseptic processing, lyophilization (freeze-drying) for unstable APIs, and depyrogenation.
All injectables undergo comprehensive sterility testing, endotoxin testing (LAL test), particulate matter testing, and sub-visible particle analysis per USP <788> and <789>, ensuring every injectable meets international quality standards for global markets.
State-of-the-art sterile manufacturing process ensuring quality, sterility, and compliance at every stage
Active pharmaceutical ingredients are precisely weighed and dissolved in Water for Injection (WFI) under controlled conditions to form a homogeneous sterile solution.
The bulk solution is passed through validated 0.22 micron sterilizing-grade membrane filters to remove micro-organisms and particulate matter prior to filling.
Sterile filtered solution is filled into vials, ampoules, or pre-filled syringes under Grade A (ISO 5) unidirectional laminar airflow within a Grade B (ISO 7) background environment.
For thermolabile and moisture-sensitive APIs, filled vials undergo controlled freeze-drying to remove water content, producing a stable lyophilized cake for reconstitution.
Where product stability permits, filled containers undergo terminal sterilization via autoclave (121°C/15psi/15min), followed by 100% visual inspection and sterility testing before release.
Advanced sterile injectable manufacturing technologies and quality capabilities
Grade A (ISO 5) aseptic filling within Grade B (ISO 7) background cleanrooms
10^-6 sterility assurance level (one in a million) for all sterile injectables
<0.5 EU/mL endotoxin limit per USP <85> LAL testing standards
Sub-visible particle limits controlled per USP <788> specifications
4.5-8.5 (product dependent) with isotonic osmolality preferred
Isotonic formulations preferred to minimize injection site irritation
Wide range of sterile injectable formulations for critical care and chronic disease management
Multiple packaging options designed for product protection and market compliance
Type I borosilicate glass vials with rubber stoppers and aluminum flip-off seals ensuring container closure integrity.
Single-dose glass ampoules for sterile single-use injectables with tamper-proof snap-open design.
Ready-to-use syringes with safety needle systems for immediate, precise-dose administration.
Discover our complete range of pharmaceutical formulations
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