Facilities

 

 

We have set up a new, state of the Art API manufacturing facility at Paithan, Aurangabad in the state of Maharashtra. Built as per CGMP requirements, the facility is designed to meet USFDA/EU GMP regulatory norms.

Our manufacturing facility offers high value, low volume production batches. It also has three independent powder processing clean rooms to manufacture various API’s. First clean room is dedicated for multipurpose API’s. Second clean room for Vitamin & Third clean room for Steroids.

The State-of-the-art facility stands on 1 acres of land and covers the following installations:

 
  • R & D
  • QC
  • QA & Regulatory Affairs
  • Manufacturing Blocks
  • Engineering
  • Warehouse
  • Materials & Finished Goods Stores
  • Utilities Building

PRODUCTION BLOCKS

Covering an area of 20,000 sq. ft in multi-level buildings, manufacturing blocks are designed. Manufacturing blocks has quality by design air-handling units as per cGMP.

The facility has three independent clean room areas. The supply of utilities and utility headers are isolated from manufacturing area to avoid congestion and cross contamination inside the plant.

ENGINEERING

Well organized GEP procedures, experienced technical team, facilities for engineering materials warehouse, fabrication and maintenance workshop, well designed centralized utilities and power backup generators.

WAREHOUSE

The facility has three dedicated warehouse covers an area of 3,500 sq. Ft. for handling of all incoming raw materials, packing materials and finished products with pre-defined storage conditions. Facilities for handling of gases, hazardous chemicals and solvents independently.

PLANT FACILITIES

 
 
  • Stainless Steel & Glass lined Reactors, Capacity Range (600 Litre to 2000 Litre)
  • Glass Assembly, Capacity Range (20 Litre to 200 Litre)
  • Operating Temperature Range (-30 degree to 100 degree centigrade)
  • Pressure Rating 1 to 3Kg Cm2
  • Centrifuges Stainless Steel
  • Vacuum Tray Dryer installed at 100000 classified areas
  • Multimill, Vibrosifter & blender installed in Clean Room & Packaging room which is 100000 classified areas
  • Environmental Control.
 

 

 

 

The layout of facility is guided by a “Quality by Design” master plan. The location of various buildings, roads & Green zones are well defined.

 

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