What is an Active Pharmaceutical Ingredient?
An Active Pharmaceutical Ingredient (API) is the component of a drug responsible for the therapeutic effect of the medication.
What are inactive ingredients?
Inactive ingredients, or excipients, are inert components of a medication. They do not affect the therapeutic effect of the drug but may facilitate acceptance, application, stability, handling or delivery of the active ingredients. Examples of inactive ingredients are fillers, colorants, flavouring agents and binding materials.
How is a medicine manufactured?
Pharmaceutical manufacturing occurs in two general steps.
1- The first step is to convert raw materials into Active Pharmaceutical Ingredients (APIs), the substances used in the manufacture of a drug product. These are intended to give pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or affect the structure and function of the body.
2- The second step is to create final formulations by mixing APIs and excipients (non-active ingredients), pressing the mixture into tablets, filling capsules or preparing solutions and then packaging the product for the consumer market.
Only a limited number of large manufacturers of finished pharmaceutical products have their own API manufacturing capabilities, and none of them can make all required APIs in-house. Most manufacturers have to buy APIs in the open market. As good quality active pharmaceutical ingredients are core to the manufacture of effective and safe essential drugs, it is very important for them to choose a reliable supplier as Dipharma, able to guarantee high quality standards.
Why should you know which active ingredient is in your medicine?
When a patient is on multiple medications, active ingredients may interfere with each other, and cause more side effects. For this reason the doctor must to be informed about all the medications the patient is taking.
What are the requirements for manufacturing active pharmaceutical ingredients?
The National Agencies of Health as the US Food and Drug Administration (FDA), expect Active Pharmaceutical Ingredient producers to apply Good Manufacturing Practices (cGMP) to the manufacturing process beginning with the use of starting materials and validate critical process steps that impact the quality and purity of the final API. Controls over material quality are expected to increase as the process approaches the final API.
What is meant by current good manufacturing practices?
Good Manufacturing Practice (GMP) is a system of production and testing practices implemented to ensure the quality of a product. Pharmaceutical firms and Active Pharmaceutical Ingredient producers apply the Current Good Manufacturing Practices in order to ensure that the products produced meet defined requirements for identity, strength, quality, and purity.
How can quality influence medicine safety and efficacy?
Quality has a fundamental role in medicine efficacy. The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and, sometimes, serious health complications.
Who is Dipharma?
With more than 60 years’ experience in manufacturing high quality active pharmaceutical ingredients (APIs) and four manufacturing facilities in Europe, Dipharma is one of the major European producers of APIs, serving a large base of pharmaceutical companies around the world. To know more about Dipharma see the page About us.