How much does it cost to build a GMP facility?

GMP Compliance Cost

Number of Employees Setup Costs*
Small Establishments <20 $26,000
Medium Establishments 20 – 500 $20,000

How much does a small manufacturing facility cost?

Factory, 3 Story Square Foot Cost Assuming Face Brick Common Brick Back-up / Concrete Frame

Cost Estimate (Open Shop) % of Total Cost
Total $8,242,000
Contractor Fees (GC,Overhead,Profit) 25% $2,060,500
Architectural Fees 6% $618,200
Total Building Cost $10,920,700

How much does a pharmaceutical manufacturing plant cost?

Facility Cost: The capital investment to build a manufacturing facility is considerable. A small pilot plant with 100L Cell culture capability may cost roughly $10 million, a 1,000L scale plant roughly $40 million, while large commercial plants with 10,000L capacity cost upwards of $200 million to build2,3,4.

How do you build a pharmaceutical factory?

Steps to Start Pharmaceutical Manufacturing unit:

  1. Prepare a Business Plan.
  2. Choose Company Name.
  3. Finalize location for premises for manufacturing unit (must compile with norms)
  4. Incorporation of Company (Proprietorship/partnership/private limited etc)
  5. Company Registration.

What is the cost for GMP certification?

Rs. 30,000/- for Indian nationals and 600 USD for overseas Professionals. This covers the certification registration fee and examination fee.

How much does it cost to open a factory in India?

However, you need to be wise in selecting the manufacturing location to avoid high transportation costs. You need approximately Rs 2 lakh-Rs 2.5 lakh for setting up the machinery and getting the raw materials to start the business.

How much does it cost to start a factory in China?

While there is no minimum capital requirement anymore for opening a company in China, it is prudent to invest a certain amount of foreign capital into the company. 3. The operational cost to open a company in China starts from USD $2000.

How much does a manufacturing facility cost?

Factory, 1 Story Square Foot Cost Assuming Concrete Block / Bearing Walls

Cost Estimate (Open Shop) % of Total Cost
Total $2,534,500
Contractor Fees (GC,Overhead,Profit) 25% $633,600
Architectural Fees 7% $221,800
Total Building Cost $3,389,900

How can I start my own pharma company?

Important Step (Procedure and Sequence):

  1. Take Experience in pharmaceutical sales and marketing and/or recruit experienced staff.
  2. Prepare a project report or take advice of pharma experts.
  3. Make a Business Plan.
  4. Choose Location for Business set-up.
  5. Finance Source (Own Saving, Bank Loan, Investment etc.)

What are the operational limitations of a biologics contract manufacturing facility?

Often overlooked in the cost calculation are the operational limitations of the facility. Many people wrongly assume that a facility can be operated at close to 100% of the theoretical capacity and use this in their planning. The biologics contract manufacturing industry is a competitive, low margin business.

What is a biologics cost of goods analysis?

A biologics cost of goods analysis or specifically, the cost of manufacturing a unit of biological material for clinical trials and ultimately for the market is an important part of the overall analysis of product value. There are several components to determining an accurate and verifiable cost of goods.

Why are biologics so difficult to manufacture?

Biologics are much harder to manufacture than chemical drugs as they are extremely sensitive. Their immunogenicity, adverse events, and efficacy can all by affected by even the slightest process change because a biologic is defined by its process.

Do biopharmaceuticals and industrial bioproducts have different cost drivers?

Specifically, we contrast cost drivers of biopharmaceuticals and industrial bioproducts, especially with regard to current good manufacturing practice (CGMP) regulations. We examine a CGMP plant and two CGMP-compliant plants. The data are compared with those and an industrial bioproduct (bioethanol) for which there are no GMP requirements.