Global-Standard API Manufacturing
Flexible infrastructure for advanced intermediates and APIs
Two Strategic
Manufacturing Locations
Megafine operates two US FDA-inspected multipurpose cGMP manufacturing facilities for APIs and Advanced Intermediates in India, located at NASHIK, Maharashtra, and VAPI, Gujarat. The Nashik facility is additionally inspected by the European EMA & EDQM, Korean FDA, Health Canada, PMDA (Japan) TGA Australia ANVISA (Brazil) and COFEPRIS (Mexico). The Vapi facility is additionally inspected by EDQM and ANVISA (Brazil).
Nashik Site (Maharashtra)
Vapi Site (Gujarat)
Our Facilities
We have multipurpose manufacturing blocks at both sites of different scale, offering flexibility across diverse chemistry and batch sizes.
Our facilities have a combined production capacity of 270 KL, including 17 production blocks, and 9 cleanrooms. A wide range of reactor types and sizes, enable batch sizes ranging from 1 kilogram to 500 kilograms – enabling seamless scalability from development to commercial production.
9
Clean rooms
17
Production Block
270 KL
Manufacturing Capacity
Comprehensive API & Intermediate Manufacturing
We operate a total of 9 cGMP clean rooms for APIs along with several multipurpose GMP production blocks for Intermediate production. Our facilities are equipped with Glass, Steel, Halar lined reactors ranging from 100 liters to 8000 liters, allowing seamless transition across R&D, pilot, and commercial manufacturing. Advanced capabilities include high-pressure and high-temperature reaction suites, hydrogenation facilities, controlled cleanrooms, and 3 micronization suites, ensuring precision, safety, and consistent product quality.
Our Cleanrooms
Our cleanrooms support wet milling, drying (Fluid Bed Dryer [FBD], Tray Dryer [TD]), Rotary Cone Vacuum Dryer (RCVD), Agitated Nutsche Filter Dryer (ANFD), milling, Air Jet Mill for micronizing, blending, packing, quarantine, and finished goods storage.
This integrated and versatile setup enables Megafine to reliably execute complex and critical chemistries, support custom manufacturing requirements, and deliver high-quality APIs at commercial scale, in line with global regulatory and customer expectations.
Future-Ready Expansion
A new state of the art brownfield project at the Nashik site is under implementation, wherein we are adding 32 reactors with a total capacity of 120 Kilo Litres along with 2 clean rooms.
