Pharma Third Party Manufacturing site should be capable of assisting in early-stage process development for both API

Posted by Akums Drugs & Pharmaceuticals Ltd on June 10th, 2023

 Active Pharmaceutical Ingredient (API)

API stands for "Active Pharmaceutical Ingredient," is the part of a drug that produces the intended pharmacological effect and is responsible for the therapeutic activity of a medication.

Simply, the API is the chemical substance that is responsible for treating a specific condition or disease. For example, in a painkiller medication, the API would be the chemical that actually reduces pain.

Pharmaceutical companies use APIs to create medications, which are then formulated into different dosage forms, such as tablets, capsules, injections, or creams. The APIs used in medications are subject to strict quality standards and regulatory requirements, ensuring that they are safe and effective for human use.

Finished drug product (FDP)

A finished drug product (FDP) is a medication that has completed the manufacturing process and is ready to be dispensed to patients.A finished drug product typically consists of the active pharmaceutical ingredient (API), which is the part of the medication that produces the intended pharmacological effect, as well as other inactive ingredients, which may include fillers, binders, and coatings.

The formulation of an FDP can vary depending on the intended route of administration, dosage strength, and other factors. FDPs can be available in different dosage forms, such as tablets, capsules, injections, or creams, and can be marketed under different brand names by different pharmaceutical companies.

Before a finished drug product can be marketed and sold to patients, it must undergo extensive testing and regulatory approval by government agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These agencies evaluate the safety, efficacy, and quality of the FDP to ensure that it meets the necessary standards for human use.

Pharmaceutical third-party manufacturing

A pharmaceutical third-party manufacturing site that specializes in contract manufacturing can provide services to assist in the early-stage process development for both active pharmaceutical ingredients (APIs) and finished drug products (FDPs).

These services may include:

• API process development: The site can offer expertise in developing the chemical process for synthesizing the API, optimizing yields, and minimizing impurities. They may also provide analytical services to characterize the API and ensure its purity and potency.
• Formulation development: The site can assist in the formulation of the FDP, including the selection of appropriate excipients, dosage form, and route of administration. They can also help optimize the drug product for bioavailability, stability, and other factors.
• Scale-up and validation: Once the process and formulation have been developed, the site can help scale up the manufacturing process and conduct validation studies to ensure that the process is robust and reproducible.
• Regulatory support: The site can provide support in preparing regulatory submissions, including documentation of the manufacturing process, quality control testing, and stability studies.

Akums Drugs and Pharmaceuticals ltd.

Akums Drugs and Pharmaceuticals ltd. is a pharmaceutical third-party manufacturing site that offers a wide range of services to support the development of APIs and FDPs, from early-stage process development to commercial-scale production. By leveraging their expertise, companies accelerate their drug development programs and bring new therapies to market more efficiently.