Loading...

Difference between FDF and API in the pharmaceutical industry

 

 

Pharmaceutical markets are showing rapid growth all over the world and in the coming years are expected to evolve further in the field of research and development, manufacturing and formulation, due to various factors such as rise in population, the increasing incidence of disease, rising healthcare expenditures, collaborations, merger, and acquisitions.

The trend of contract manufacturing is expected to increase its share in the pharmaceutical manufacturing market. The contract pharmaceutical manufacturing primarily focuses on the manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF). A major reason for the increase in the API market is the availability of small molecule drugs for all the major diseases and a large number of small molecule drugs in the pipeline, which is expected to enter the market in the future. This arises the need to understand and distinguish between FDF and API, very frequently used terms in the pharmaceutical industry.

FINISHED DOSAGE FORM (FDF)

  • FDF stands for the finished dosage form. The finished dosage form refers to the actual finalized drug product that is meant for the final consumption by the patient. All drugs are the combination of the API ( central ingredient) and other excipients (chemically inactive substances) with a fixed production set by the standard drug regulating authorities like FDA, that make the final product that one buys from the pharmacist.
  • FDFs can take a variety of forms such as solid tablets or capsules, injectable dosage form solution, or another such type.
  • FDF manufacturing is the fastest-growing segment with a strong CAGR from 2018 to 2025 because it provides high-profit margins to pharma contract manufacturers. Thus, most of the CMO companies in APAC regions are shifting from API to FDF manufacturing.

ACTIVE PHARMACEUTICAL INGREDIENT (API)

  • API (active pharmaceutical ingredient) is that component of the drug which enacts the desired or claimed pharmacological effect in the consumer’s body. API is the base molecule or the raw material from which the final medicine is manufactured. It is a bulk drug from which branded and generic medicines are prepared.
  • Some drugs such as combination therapies contain multiple active pharmaceutical ingredients (APIs). Certain standards are used by the manufacturers to determine how strong the API is in each drug. Every brand uses different test methods. But in all cases, manufacturers are required by the FDA to prove the potency of their products in real-life patients and laboratory conditions.
  • The manufacturing market of API holds the largest share in 2018 and is expected to grow at mid-single-digit CAGR from 2018 to 2025, thanks to the various government initiatives, increase in the number of API manufacturers, increasing availability of APIs for almost all the diseases, aging population, rise in chronic diseases among the population, research, and manufacturing of new drugs and demand for generics.

We, at Maxnova Healthcare, provide high-quality, reliable, and sustainable finished dosage forms (FDF). We believe a “healthy life leads to a vibrant future,” which has cheered us to go ahead and start engaging people. That’s why since 2010, we’re persistently moving forward to achieve our goal to become a global healthcare venture and recognized as an international and domestic integrated pharmaceutical and healthcare company. Our vision is to establish Maxnova Healthcare as one of the best pharmaceutical companies in India in terms of innovation, expertise, and responsible entrepreneurship. We aim at providing the next-generation solutions to society with an insight into how innovations and research can shape a better future. We are not alone in our journey. Maxnova Healthcare is blessed with a very talented and hardworking team of professionals that encourages us to bring a perfect amalgamation of knowledge and cutting-edge technology into action and form a revolutionary product. If you are interested in growing with us, feel to contact us. We are always here for you.

 

MAXNOVA HEALTHCARE

Address: Ambala Chandigarh Expy, Baldev Nagar, Ambala City, Haryana, 134007

Contact us at +91-7027361624 or Email us at bhanu@maxnovahealthcare.com