What is an API in pharmaceutical manufacturing?

API stands for active pharmaceutical ingredient, meaning that it’s the active ingredient in a finished drug. An API is what produces the intended effects of a drug. This means that APIs are one of two main components in drugs, the other half being the excipients, chemically inactive substances that deliver the effect of API.

Therefore, APIs are incredibly important as they are what makes a drug act in a certain way. However, it’s important to understand that APIs aren’t drugs on their own, they require an excipient and must be processed properly to become safe medicine for clinical application.

What are some examples of pharmaceutical APIs?

To fully understand pharmaceutical APIs, let’s look at some common examples and explore what the active ingredients are:

• Peptide APIs – Peptides or polypeptides are used as therapeutics for illnesses such as diabetes, cancer, cardiovascular diseases and others. Given that peptides can be metabolised by the body, and can mimic those that naturally occur in your body, peptide therapeutics are thought to be generally safe.
• Small molecule API – They serve as the pharmaceutical industry’s mainstay. These products, which can largely be delivered orally, have significant therapeutic advantages.
• Oligonucleotide APIs – Oligo APIs are a versatile therapeutic with the potential to treat a variety of illnesses. A variety of therapies use approved products, for e.g. neuromuscular illnesses and ophthalmologic indications. This shows as well in the fast growing demand for oligonucleotide APIs worldwide.
• Generic APIs – The active pharmaceutical ingredient (API) in a generic drug is the same as that in the brand-name medication, but there may be differences in the manufacturing method, formulation and excipients.

Why are pharmaceutical APIs so important?

Active Pharmaceutical Ingredients (APIs) are the core components responsible for the therapeutic effects of medications. Without APIs, drugs would not have the desired health benefits. They are essential for the efficacy, safety, and consistency of medicines.

The quality and purity of APIs directly influence the final product, making them a critical focus for pharmaceutical companies to ensure reliable and effective treatment options for patients.

The API manufacturing process?

APIs are manufactured from their raw materials, meaning several chemical compounds go through a process called intermediate before becoming an API. The process of API manufacturing typically involves several steps, including chemical synthesis, purification, and isolation. The specific steps involved in API manufacturing can vary depending on the type of compound being produced.

Some common methods used for manufacturing APIs include recombinant production, chemical synthesis or isolation from natural sources. 

Once the API has been produced, it can be formulated into a final product, such as a tablet or capsule, for use by patients. Rigorous quality checks are carried out before being released to the general public.

Why choose Bachem to develop and manufacture APIs?

Choosing us, Bachem, to develop and manufacture APIs means partnering with an industry leader dedicated to delivering high-quality, innovative solutions. We offer expertise throughout the entire API lifecycle, from initial discovery to large-scale production. With state-of-the-art facilities and a strong commitment to cGMP compliance, we ensure the highest quality and safety in every batch. Our advanced technologies and collaborative approach help streamline the development process, providing pharmaceutical companies with reliable and efficient API solutions.