• nashik site

    Megafine has two US FDA inspected multipurpose cGMP API and Advanced Intermediate manufacturing facilities at Nashik, Maharashtra and Vapi, Gujarat in India. Besides the Nashik facility is also inspected by European EMEA, Korean FDA & approved by Japanese PMDA.

    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 8.07 acres of land. The total area of the site is 32,667.00 sq. meters with an existing built up area of 17390.20 sq. meters.

    The site has a total of five multipurpose API Production Blocks with dedicated manufacturing streams in each block. The blocks have been designed in a way that a single batch size as low as 2 kg & going up to 500 kg can be taken under cGMP environment.

    The site is self- sufficient & has Pilot plant, Research & Development (R&D) Labs, Analytical Research & Development (AR&D) Lab, Quality Control (QC) Lab, Validation cell, Quality Assurance dept., Regulatory Affairs dept., Environment Labs besides 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]), Rotary Cone Vacuum Drier (RCVD), Agitated Nutsche Filter Dryer(ANFD) 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 10µm, 3µm and 0.3µm filters (HEPA) with minimum 30 air changes/hr. Micronizing facility is available at the site for particle sizing.

    An intermediate production block for large volume products is available under cGMP environment. . 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 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 inspected by US-FDA, European EMA, Korean FDA,WHO & approved by Japanese PMDA.The site is also certified for, ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007.

    The site has the following Accreditations

    Authority Abbreviation Country Certification
    Food and Drug Administration, USA USFDA USA USFDA
    European Medicines Agency EMA Slovenia JAZMP
    Pharmaceutical and Medical Devices Agency PDMA Japan AG12300130
    Korean Food and Drug Administration KFDA Korea KFDA
    Food and Drug Administration, Maharashtra State FDA India GMP
    Ministry of Health, Iran MoH Iran MoH
    World Health Organization WHO International GMP
    Written Confirmation for EU CDSCO India EU WC
    Occupation Health and Safety Assessment Series OHSAS India OHSAS 18001:2007
    International Organization for Standardization ISO India ISO 14001:2004
    International Organization for Standardization ISO India ISO 9001:2008
    Dun & Bradstreet Corporation (Nashik Site) D&B D-U-N-S USA 92-562-7080