Active Pharmaceutical Ingredients (API)
Aevitas has conceptualised and engineered facilities in API, HPAI, Peptides and Sterile API for various pharmaceutical companies. The plant designs meet NBC, Factory Acts, ISPE Baseline, ICH Q7 & ICH Q 9, FDA and WHO guidelines and safety guidelines of OSHA, NFPA etc.
Aevitas’s engineers are well versed with the containment and closed transfer needs as per the potency level of the product handled.
Our experience includes special reactions like hydrogenation, cryogenic reaction, sodium metal reaction, nitration, bromination and many more.
We have engineered equipment like reactors, distillation columns, short path distillation units, continuous & batch centrifuges, rotary pressure filter, spherical dryer, fluidized bed dryer, agitated thin film dryers, agitated Nutsche filter dryer, spray dryer, scrubber, jet mill, powder processing & transfer systems, conventional utilities, single fluid systems and purified water systems.
Our team of engineers have been involved in the engineering, construction and commissioning of API manufacturing plants as well as solvent recovery systems.
Projects
API Facility in Karnataka
Aevitas has leveraged its expertise in API and project management to provide basic engineering, cost estimate, detailed engineering, project management and construction management for multipurpose API, clean room (designed as per USFDA, EU, GMP, WHO guidelines), warehouse, canteen, ETP and solvent storage.
API Facility in Bangladesh
The facility comprises of multipurpose API manufacturing with a kilo lab and a pilot plant, warehouse and R&D labs, hazardous reaction block, utilities, tank farms, solvent recovery, offices, dormitory and plot infrastructure. Aevitas provided basic engineering, master planning, detailed engineering, procurement assistance and validation documentation for the greenfield facility.
Multi-Purpose API Facility in Madhya Pradesh
Aevitas provided detailed engineering, construction management and validation assistance for multipurpose API manufacturing facility, clean rooms and tank farm. It also provided detailed engineering for drum store, product development lab and warehouses for this large multi-national company. The facility complies with USFD and cGMP regulations.
Greenfield API facility for Overseas and Indian Joint Venture Company in Andhra Pradesh
Aevitas provided URS, master planning, basic engineering, detail engineering, construction management and validation assistance for a multipurpose/multi-product API manufacturing complex. The state-of-the-art facility comprises API and intermediates manufacturing, warehouse, electrical substation, administrative offices, utility block, plot infrastructure and complies with cGMP and USFDA regulations.
High Potent API Facility for a Pharmaceutical Major in Andhra Pradesh
Aevitas’s mandate included providing basic engineering with costing and detail engineering for High Potent API. Dispensing, charging, filtration & drying, loading & unloading, milling, sifting, blending and packing operations carried out in a contained manner using flexible and fixed isolators.
Brownfield API expansion for an Indian Pharma major in Karnataka
Aevitas’s mandate included detailed engineering, procurement assistance and construction supervision for a new API manufacturing block, its cleanroom and hydrogenation block. It also involved utility review and up-gradation recommendations for the complex. Crystallization, drying, filtration and packing activities are carried out in a cleanroom under temperature/RH controlled and ISO 8 classified environment.
Clients
