REGENIX BIOSCIENCES LTD - Our state of the art biosimilars. Factory is located in special economic zone in tambaram.
Our top of the notch engineering facilities consists of water purification unit to make sure purified water and water for injection is available for the manufacturing process and chemical analysis. The HVAC systems run 24/7 to make sure the particle size in the production areas are kept at USFDA standards.
The production areas are kept clean at all times before the start of a batch and after completion of the batch. As biosimilars are injectables the sterility of the Environment is maintained at all times by the use of proper Sterile suits.
Our Quality control team make sure that the API received is tested and meets our Strict standards. The finished product is also tested and made sure that all parameters are within control levels. Our microbiology team conducts regular sampling of each batch for any growth and also conduct Air sampling at regular intervals
Our quality assurance department is ever vigilant in making sure that all the rules and regulatory approvals needed for the functioning of the plant is obtained. They follow a meticulous system of documentation. Our IPQA & QCQA personnel make sure that the quality of manufacturing and testing is maintained to the highest standards
The plant is located in the pharmaceutical zone at Chennai. This plant is a WHO GMP accredited plant. Alathur plant is capable of manufacturing tablets & capsules.The formulation manufactured at our OSD plant is exported to South American countries & Philippines. Products are under registration in several other countries.