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How much do cGMP Chemicals Cost?

How are cGMP chemicals priced?

Have you wondered how much do cGMP chemicals cost?  As with any pricing process, the price includes direct costs, such as the chemical itself, the packaging, and the labor. It also includes indirect costs, such as overhead. And of course, the price includes profit. But let’s breakdown those costs to better understand how a final price is established.

A. The chemical:

B. The packaging:

  1. Material of construction—poly, steel, Teflon®-lined, stainless steel, glass
  2. Size—tote, drum, carboy, pail, bottle
  3. Over-pack requirements to meet DOT regulations
  4. Inner-pack requirements for safe transportation
  5. Closures—material of construction, gasket material, specialized
  6. Labels

C. The labor:

  1. Manufacturing the product
  2. Packaging the product
  3. Special handling requirements—PPE, hoods, etc.
  4. Paperwork required for traceability and compliance
  5. Set up / clean up
  6. Number of people needed per job
  7. Chemical handling training

D. The Overhead: These are the costs required to run a business which cannot be directly attributed to any specific business activity, product, or service.

  1. Rent
  2. Property taxes
  3. Utilities
  4. Salaries
  5. Normal scrap
  6. Depreciation on production equipment
  7. Insurance on production equipment, facilities, and inventory

E. Shipping requirements:

  1. Pallet— heat-treated wood, plastic
  2. Extra services—for example, temperature controlled containers, custom blocking and bracing, etc.