Megafine Pharma (P) Ltd.

Nashik manufacturing site is located about 210 km northeast of Mumbai on the State Highway No. 17, in Lakhmapur, Dindori, Nashik, Maharashtra, India (Place/Taluka/District/State/Country). The distance to the plant from Nashik city is 30 km.

The site is situated on a private industrial area spread across 6.68 acres of land. The total area of the site is 27,064.87 sq. meters with an existing built up area of 12,562.52 sq. meters.

The site has a total of five Production Blocks with dedicated manufacturing streams in each block, apart from a Research & Development (R&D) Laboratory, Analytical Research & Development (AR&D) Laboratory, Quality Control (QC) Laboratory, Raw Material Stores, Finished Goods Stores, Utility Section, Liquid Material Storage and Effluent Treatment Plant (ETP).

The production blocks have multiple streams designed for the manufacturing and packaging of Active Pharmaceutical Ingredients (APIs) and Intermediates. Production Blocks are connected to the Clean Rooms which consist of Wet Milling, Drying (Fluid Bed Dryer [FBD], Tray Dryer [TD]), Roto Cone Vacuum Drier (RCVD), Milling, Blending, Packing, Quarantine and Finished Good Storage areas. Its design meets the clean room ISO 8 class 100,000 standards and positive pressures are maintained as required. The air supplied is filtered through 10m, 3m & 0.3m filters (HEPA) with minimum 30 air changes/hr.

A new intermediate production block for large volume products is under implementation. The site has a centralized Quality Control Laboratory which is equipped with modern testing instruments and equipments. The Quality Control Lab is also supported with a well equipped microbiological laboratory.

The site has a well planned utility system which ensures the regular supply of steam, electricity, filtered air, chilled water and purified water. The entire system is orderly placed to avoid cross contamination and mix-ups, and to meet the regulatory requirements.

The equipment installed allows a wide range of process variables in operation conforming to Current Good Manufacturing Practice (cGMP) requirements.

The Nashik site is successfully US-FDA inspected and WHO-GMP, ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 certified.

Vapi manufacturing site is located at a large industrial township in GIDC (Gujarat Industrial Development Corporation), Vapi, Gujarat, India (City/State/Country) which is about 186 km North of Mumbai city on the national highway NH-8. The distance of the plant from Vapi railway station/town is around 5 km.

All processes related to manufacturing of various drug intermediates involving chemical synthesis, isolation, purification, drying, milling, blending and packing, in process controls and testing by the quality control laboratory, etc. are carried out at this site.

The site has three manufacturing blocks, apart from Quality Control Laboratory, Raw Material Stores, Finished Goods Stores, Utility Section, Boiler Room and Effluent Treatment Plant (ETP). The production blocks have multiple streams designed for the manufacturing and packaging of Advanced Intermediates. Production Blocks are connected to the Clean Room which consists of Wet Milling, Drying (Fluid Bed Dryer [FBD], Tray Dryer [TD]), Milling, Blending, Packing, Quarantine and Finished Good Storage areas. The area is controlled under forced ventilation (VUS & VUE) with proper air filtration of 20m, 10m & 3m with minimum 30 air changes/hr.

The site has a well planned utility department which maintains regular supply of steam, electricity, cooling water, chilled water, D.M. water, vacuum, air, nitrogen, etc.

The entire system is orderly placed to avoid cross contamination and mix-ups, and to meet the regulatory requirements.

The equipment installed allows a wide range of process variables in operation conforming to Current Good Manufacturing Practice (cGMP) requirements.

The Vapi site is successfully US-FDA inspected and ISO 9001:2008 certified.