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Our Facility

About Our Plant


Edkem Pharmaceuticals Ltd is an WHO cGMP Approved Facility located in the industrial belt of Ahmedabad at barely 20km distance off the main city. It is pleasantly surrounded by an entire pharma ecosystem with many accessory industries (Raw Material suppliers, PM suppliers, transporters, etc.) in the near vicinity. The plant is designed in a manner to sufficiently take care of its current needs and its future needs. The infrastructure is created with a view to comply with all national and international guidelines including and not limiting to WHO GMP, USFDA, MHRA, TGA and PICS.

Infrastructure

Spread across a constructed area of 50000 sq ft, the general section of Edkem Pharamceuticals Ltd. boasts of all latest innovations in infrastructure. Salient features of the infrastructure include 100% clean room partition in production area, full epoxy floorings in critical areas, MAL PAL in all critical areas, material hoist for movement of material in between the floors, sufficient quarantine space after every batch process to prevent hold up of the machinery and a state of the art laboratory completely independent of the production area.

Processes

The plant is designed in a manner to ensure unidirectional flow of material in all the formulation sections. All the sections are completely independent of each other with dedicated manpower and machinery allocated to each of the sections. There is a restricted man movement in the production area with packing staff restricted only till the packing area. The entry in the production area is through restricted access control system. All the major and minor processes are governed through SOP’s. Manpower training is undertaken on a routine basis to acquaint the manpower with the systems and processes to be followed in the plant

Utility

It is our firm belief that good quality products require controlled quality environment during the course of its production. We lay strict emphasis on the supply of utilities like compressed air, Purified water and air conditions for the same reason.

  • Compressed Air: 100% oil free compressed air with air filters used
  • Water System: We utilize 2 pass RO with CSEDI system
  • Air: Controlled flow of air with necessary temperature and humidity conditions achieved by the use of AHU’s (Citizen Make), outdoor chillers (Blue Star make) and dehumidifiers (Bry Air make)

R&D Centre

We have an in-house state of the art laboratory and research centre where we perform analysis of our existing and new products and undertake product development studies. It is equipped with a physio-chemical lab, two instrument labs and a microbiology lab. In house stability studies is conducted to check the shelf life and stability profile of existing and new products. An in-house well equipped centre helps us to deliver the products in a time bound manner with all test compliances.

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