Finished Dosage Forms and APIs: How Are They Different?

A finished dosage form (FDF) describes the consumable, finalized drug product - tablets, pills, liquid solutions, and other forms of FDFs all come under this category. However, all FDFs include an API along with other inactive components.

The two main parts of any pharmaceutical product are the active pharmaceutical ingredient (API) and the excipient (additional chemicals used to aid in the drug's delivery). Chemically inert fillers like lactose or cellulose derivatives would be some examples of the excipients

To put simply, APIs form the crux of the finished dosage form - the main ingredient that’s meant to meet the objectives of the prescription.

Each drug's (API) strength is measured against industry standards during production. However, there might be significant variations in quality across different manufacturers. The testing procedures used by each manufacturer can cause substantial variations in product efficacy.

The FDA requires manufacturers to demonstrate their medications' efficacy in laboratory settings and clinical trials involving actual patients.

APIs are often manufactured in the home countries of pharmaceutical corporations. However, in recent years, many businesses have elected to outsource production to countries with lower labor costs. Because of this, stricter criteria and inspections have been implemented to regulate these medications.

Although numerous pharmaceutical businesses can be found in the United States and the United Kingdom, most API manufacturers are located outside these countries. The most populous ones can be found in Asia, especially in China and India.

In order to save money on resources like staff and building maintenance, an increasing number of businesses are outsourcing. Despite the positive impact on their bottom line, there remains persistent worry about the quality of APIs in foreign countries.

Comparison between APIs and Finished Formulations

The efficacy (achieving the desired effect) and the safety of drugs are significantly impacted by the quality of their active pharmaceutical ingredients. Substandard or degraded APIs have been linked to major health problems and fatalities.

APIs are still subject to the country of destination's strict regulations and oversight, even in the case of outsourcing. For instance, the U.S. Food and Drug Administration still inspects foreign API factories.

The development of APIs indicates the dynamic nature of the pharmaceutical sector. Today, pharmaceutical manufacturing is a more decentralized process. Before, the API, capsule, and packaging were all made and distributed by the same company.

The regulatory agencies charged with ensuring the public's safety have responded by instituting stringent checks on all pharmaceuticals. A violation of these defined rules may result in fines or a highly costly recall for the pharmaceutical firms backing these businesses.

According to a recent industry study, injectable Finished Dosage Forms are expected to dominate the market from 2020 to 2027, where APIs accounted for the greatest market share in 2020. Growth in this sector is anticipated to be propelled by factors like the growing demand for innovative and generic medicine formulations.

Revenue from generic API manufacturing was the largest in 2020 and is projected to increase as patents on branded medications expire, and generic drugs become more affordable.

Conclusion

In spite of their conceptual differences, Finished Dosage Forms and APIs are inseparable when it comes to the research, development, and manufacturing of novel formulations and drug delivery methods

About ZIM Laboratories

ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets(immediate, sustained, modified and extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).

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