Manufacturing

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

NASHIK SITE

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 10?, 3?& 0.3? 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 equipment??. 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 Baddi 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.