The API (Active Pharmaceutical Ingredient) Industry, is a conglomeration of companies and organizations who are focused on the production of active pharmaceutical ingredients through both physical, biological and chemical means.
Today, thousands of pharmaceutical companies from around the world are increasingly turning to API manufacturers to help enhance their operations and efficiency. This is because outsourcing their manufacturing needs allows companies to be able to grow and expand to meet the needs of an evergrowing, and increasingly competitive market.
For pharmaceutical companies, every step of the production process is extremely important. This, of course, includes the development and production of APIs, which pharmaceutical companies rely on to be able to create medications.
Remember, APIs are one of the most important aspects in the production of medication, therefore, it’s vital that pharmaceutical companies deal with suppliers who have good reputations and are capable of delivering high-quality APIs.
All lot of this can make finding API manufacturers seem like a complicated process. However, there are several things that pharmaceutical companies can do to ensure they are working with a credible supplier. Below, you’ll find several points to consider when looking for an API manufacturer.
Run a Background Check
As it is in industry, when looking for high-quality products and service, the number one rule of thumb is to always run a thorough background check on your supplier.
Make sure to find out if they are capable of providing their customers with the right strategies for the sourcing and procurement of pharmaceutical ingredients. This step is paramount in finding a supplier that is right for your company’s specific needs and expectations. Read more about sourcing here.
Not only will running a background check on your supplier reveal valuable information about the company’s market standing, it can also help you find out about their financial strengths, business practices, licensing requirements, as well as who their existing clientele already are.
Responsibility and Customer Guarantee
A credible API supplier should always take full responsibility and stand behind the products that they supply. They should also provide customers with a clear policy stating that they agree to meet the terms and conditions of their policy should any of their products ever fail to meet the quality demands of the customer.
Remember, these suppliers deal with pharmaceutical ingredients, therefore, the quality of their product could be a matter of life and death.
As mentioned above, the quality of your supplier’s product could have dire consequences if not ensured and upheld. Therefore, it’s crucial to make sure that they are consistently able to supply you with high quality pharmaceutical substances.
Compliance and Confidentiality
You can find out a lot about your supplier’s level of regulatory compliance when you run your background check on them. Just make sure to dig a little deeper when it comes to their policies on storage of APIs, as well as production, packaging and labeling, to make sure that they comply to all FDA regulations.
Confidentiality is also vital when dealing with suppliers, therefore make sure to choose a supplier who maintains 100% confidentiality with their customers.
Read more about API industry compliance: https://www.pharmoutsourcing.com/FeaturedArticles/187977-The-Five-Competencies-of-Continuous-Regulatory-Compliance/
Cost and Efficiency
While finances are of the utmost important when looking for a supplier to build a long-term partnership with, costs should not be the only thing to consider.
The best suppliers should also provide their customers with a wide range of services from sales and logistics to warehousing and customer support. This means that your API supplier needs to be both cost effective, as well as efficient, to meet your needs as a customer.
With this in mind, it’s a good idea to get quotes from several suppliers before making your decision. And, while you’re in the process of talking to different suppliers, be sure to consider all expenses such as sales costs, insurance and duties, which all add to your total manufacturing cost.
Leading API Manufacturers
In more recent years, we have seen an undeniable shift in the API industry, which has seen many of pharmaceutical leaders move their production from Western nations, to countries such as India and China. According to study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines, this trend is expected to continue in the coming years as both countries continue to see growth rates of nearly 20% per year.
Today, with a global market share of almost 43%, China remains a world leader in anti-infective APIs, while other countries such as Italy take the lead in other sectors such as central nervous system and cardiovascular APIs.
Both China and India have been seeing so much growth recently due to their lower production costs. In fact, in India, the combined cost for develop, manufacture, test and market a generic drug only cost between 20% to 40% of what it would in Western countries.
Therefore, as large pharmaceutical companies continue to grow and outsource their manufacturing needs, the industry is only expected to grow even more in the coming years. Because of the fundamental role API manufacturers play in the development of new drugs, pharmaceutical companies need to be absolutely sure about the suppliers they choose to deal with. Therefore, it’s important to full consider all of the points mentioned above. Read more here.
Specializing in the research and development of oncological pharmaceuticals, APICMO is an industry leader that provides system development, mass production and synthetic customization for institutions and pharmaceutical companies around the world.
Behind the scenes, APICMO has a solid research and development team of knowledgeable professionals and experienced scientists. APICMO also runs a large-scale production plant, which is managed by their business development team to ensure efficient operations.
APICMO’s team profits from the experience of experts from a variety of developed countries such as the U.S., Japan and Europe. Combined, their team has more than 10 years of experience in the API industry, which ensures a broad base of cooperation within the pharmaceutical company.
Read more on pharmaceutical research and development here: https://pharma.elsevier.com/