How to Choose the Right Pharmaceutical Contract Manufacturer

Key Considerations When Selecting a Pharma Contract Manufacturer

Consider the nature, size and maturity of your business, as well as the properties of the pharmaceutical products you'd like to make. Make sure that the generic drug manufacturer that you are considering is a suitable match as a commercial pharmaceutical manufacturing partner by focusing on these critical criteria.

Quality, Compliance and Confidentiality

A prospective generic drug manufacturer's reputation and track record is a crucial factor to consider for both generic pharmaceutical companies and those selling trademarked products. A defective or tainted product that reaches consumers can result in recalls, disastrous press and even lawsuits. Even though the manufacturer made the error, the pharmaceutical brand will suffer as well.

You can assess a pharmaceutical contract manufacturer's trustworthiness by reviewing the FDA's Good Manufacturing Practice system, which evaluates drug manufacturers' issues in their production facilities. Be sure that any company you're considering has a good track record with the FDA.

Like quality and compliance, a pharmaceutical contract manufacturer must keep clients' trade secrets confidential. Business ethics are paramount when dealing with high-stakes information. It's a good idea to ask not only whether a manufacturer will protect your firm's privacy but also how they plan to do it.

Experience, Capabilities and Scale

Consider the CDMO's track record in the class of drugs that you will be manufacturing. A company with a good performance history in the manufacture of antibiotics may not have the experience necessary to start manufacturing vaccines.

Generic pharmaceutical companies have an advantage in this space because, as a pharma contract manufacturer, they may have experience making the exact drugs that need to enter production.

Research the types of employees and equipment the generic pharma manufacturer has. The pharmaceutical contract manufacturer executives should willingly provide this information during the selection process.

An essential aspect of a manufacturer's capabilities is how they can scale their production to fit their clients' needs. Crucially, the manufacturer that can produce at the largest scale isn't always the best option. Some drugs, particularly those for rare conditions, might need to be made at a lower volume. A manufacturer that can accommodate this low output while maintaining a competitive price would be ideal in these cases.

There are further, more complex questions that will arise in specific cases. For instance, a pharma company might need to know how flexible the company's production volume is. Will it take months to add additional capacity? This might be a very important or insignificant question depending on whether one anticipates fluctuating demand for the product.

Where is the Pharmaceutical Contract Manufacturer Located?

The location of a generic pharma manufacturer and their commercial manufacturing facility is a large part of the calculus of whether or not to hire them. There are many advantages for a pharmaceutical company when their pharma contract manufacturers are nearby their offices.

Since a large amount of communication is essential in the relationship between the pharma company and contract manufacturer, it stands to reason that a substantial number of face-to-face meetings will not only be necessary but incredibly beneficial. If your staff doesn't have to travel long distances, especially overseas, the costs associated with the relationship will sharply decrease. For this reason and others, the tide has turned, and many generic pharmaceutical companies are focusing on bringing their pharma manufacturing back to the US.

Is the Pharma Contract Manufacturer Responsive?

Communication is a crucial aspect of success in the pharmaceutical industry. Information, expectations and deadlines must flow effectively. In order to meet deadlines, the pharmaceutical contract manufacturer needs to respond promptly to your questions or concerns.

Knowing who to call when there's a problem that needs an urgent solution can prevent issues from arising or help deal with them as soon as possible. If a manufacturer isn't responsive while you're considering doing business with them, it's unlikely that will change in the future. Be sure that it's possible to build strong relationships with key people in an organization early on — you'll be thankful later.

Read more about trends in generic drug manufacturing