MANUFACTURING
Production of our bulk drugs (APIs) employs the process of organic chemical synthesis performed in multi purpose reactors in batch operations which is followed by isolation of the product via extraction, crystallization & filtration. Finished products are then dried, milled & blended. It is a complex multi step process where product from one step becomes a starting material for the next step, until the finished drug product is synthesized.
Further, active drug substances (APIs) and inert materials are combined during pharmaceutical manufacturing to produce dosage forms of medicinal products. The ingredients are further processed depending upon the type of intended dosage form. All stages of manufacturing involve vigilant monitoring, adhering to standard SOPs and extreme precaution to avoid contamination to the product & the operators.
Manufacturing of our products takes place in segregated facilities mainly as SVAPI blocks (Small Volume Active Pharmaceutical Ingredients), LVAPI block (Large Volume Active Pharmaceutical Ingredients) and the Formulation block.
SVAPI – I & II
Small Volume Active Pharmaceutical Ingredients i.e SVAPI I & II is used for manufacturing of our general APIs & their intermediates.Equipped with high class equipment ranging from stainless steel & glass reactors, chromatographic columns, agitated Nutsche filter dryers, Halar coated centrifuges to sparkler filters and multi mills, the facility is a classified (Class ISO-8) manufacturing area with dedicated HVAC systems and skilled professionals. We also possess a separate dedicated hydrogenation facility to cater to requirements.
SVAPI – III
The world is advancing towards high potent drugs for therapy to gain maximum therapeutic benefits with minimal doses. Manufacturing of such drugs is challenging due to the specialized pre requisites for such facilities. We practice the highest Environment Health & Safety (EHS) industrial practices for handling cytotoxic drug compounds & distributing the end-products worldwide with secure supply chains in place.Use of isolator systems allows for complete containment of the environment where the product is manipulated restricting production operators and the surrounding environment from exposure.
LVAPI – I to IV
Our large volume API manufacturing facility inaugurated in 2019 is equipped with state of the art equipment to cater to our customer’s growing requirements of higher volumes of APIs.The facility has a capacity of up to 450 TPA and is segregated into dedicated blocks for the manufacturing of specialty products as-Polymer blockIron block Multipurpose block
LVAPI- V
Our dedicated facility for the manufacturing of key starting materials and intermediates of polymer products was flagged off in December 2018 with the flagship product being Polyallylamine HCl and base. The facility is constructed with clean room modular panel and supported with all essential utilities like Brine, cooling water, hot water, compressed air, nitrogen etc. It is equipped with the capacity to produce 300 MT of intermediates per annum.
The facility not only caters to our in house requirement of intermediates but also now handles commercial orders.
Generic Oral Solids
The facility layout for our formulations is as per cGMP and international guidelines. Area is spread across approx. 1220 sq.m and is equipped for manufacturing of oral solid dosage forms at a scale of 10 to 300 kg in a single lot. From dedicated air handling units for each operations, bubble air locks to differentiate areas, Alu Alu blister packing machines, automated bottle filling lines to compression machines and the series of dryers, our products are manufactured using the best of technology.
Generic Parenterals
All our injectable products are manufactured at certified and approved CMO sites which are regularly inspected and monitored for quality and compliance.
Topical Semi Solid Formulations
We are expanding our facilities to manufacture topical semi solid formulations as part of our expansion plan
Our new centralized warehousing facility is fully equipped to handle the unique flow of raw materials, finished products and packaging materials. The facility consists of dedicated areas for Quarantine, Approved and Rejected material storage. With separate blocks for the storage of solid, liquid and gaseous materials, it also possesses dedicated areas for the storage of Carbon, hazardous and flammable materials. It has the capacity to handle and store 660 KL of solvents in drums and tanks along with 30 MT of solid raw material and 40 MT of finished goods. Marked separate areas have been incorporated for the sampling and dispensing of hazardous substances, raw materials and finished products. Also, goods can be stored in a temperature range of ambient to – 20 degrees.