Built with Science. Crafted with Care.
Advanced Biosimilars Manufacturing Excellence
Regenix Biosciences operates a state-of-the-art facility in the Tambaram Special Economic Zone (SEZ) , equipped with advanced water purification systems, round-the-clock HVAC controls, and USFDA-compliant cleanroom environments, ensuring the highest standards of precision and quality in biosimilar manufacturing.
Precision in Every Process
Regenix Biosciences operates a state-of-the-art facility in the Tambaram Special Economic Zone (SEZ), equipped with advanced water purification systems, round-the-clock HVAC controls, and USFDA-compliant cleanroom environments, ensuring the highest standards of precision and quality in biosimilar manufacturing.
Engineering
Our state-of-the-art engineering facilities feature an advanced water purification system that ensures a continuous supply for injection, essential for both manufacturing and chemical analysis. Operating round the clock, our HVAC systems maintain precise environmental conditions, ensuring particle levels in production areas consistently meet the stringent standards of the USFDA.
Production
The production areas are meticulously cleaned before the start of each batch and after its completion to ensure the highest levels of hygiene. Since biosimilars are injectable products, maintaining environmental sterility is paramount. This is achieved through the use of certified sterile suits and strict adherence to aseptic protocols at all times.
Quality Policy
Our Quality Control team ensures that every Active Pharmaceutical Ingredient (API) received is thoroughly tested and meets our strict internal standards. Each finished product undergoes comprehensive testing to confirm that all parameters remain within specified control limits. Additionally, our Microbiology team performs routine batch sampling to detect any microbial growth and conducts air sampling at regular intervals, ensuring the highest levels of product safety and environmental sterility.
Quality Assurance
Our Quality Assurance (QA) department remains ever vigilant, ensuring that all regulatory approvals and compliance requirements necessary for plant operations are fully met. The team follows a meticulous documentation system, maintaining complete transparency and traceability across all processes. Our dedicated IPQA and QCQA personnel uphold the highest standards of manufacturing and testing quality, reinforcing our commitment to excellence at every stage of production.
Where Innovation Meets Quality - Our SIDCO OSD Plant
The plant is located in the Pharmaceutical Zone at Chennai and holds WHO-GMP accreditation, reflecting our commitment to global quality standards. The formulations manufactured at our OSD facility are exported to South American countries and the Philippines, while several other products are currently under registration in multiple international markets.
