Active Pharmaceutical Ingredients and Intermediates

What Are APIs?

Active pharmaceutical ingredients are the active components used to produce pharmaceutical products that possess the essential quality and effect in the body for ailing treatments for diabetes, cardiovascular diseases, neurological therapies, and many others. These API intermediates are formulated with chemical compounds, contributing for the production of finished items or pharmaceutical drugs.

APIs are technically the chemical building blocks to create active Pharma logical components which consist of electrochemistry, alkoxylation, and amination. The API intermediates market is segmented into categories: commodity, therapeutic use, intermediates type, and geography. It  can also be determined by its application.

API intermediates are compounds or agents used as raw materials for the formulation of Active Pharmaceutical Ingredients (API). Amination, hydrogenation, alkoxylation, hydroformylation, electrochemistry, acetylene chemistry, phosgene chemistry, and other technologies are used to manufacture these intermediates. The type of intermediates include patent and non-patent intermediates.

How Are APIs Made?

API and raw intermediate pharmaceutical ingredients are similar terms but have different uses. Raw materials contain chemical components used to produce APIs. And creating APIs involves the selection of compound structure, producing a high quantity of the chosen API, and analysis of the chemical compound for quality control and assurance. API pharmaceutical manufacturing companies usually have set standards to determine the size and strength of an API for a specific medication or product.

Maintaining The Quality of APIs

Apart from having a quality management division to assess the API product quality, these are 2 of the many aspects of quality maintenance:

Process

The integrity of the process of manufacturing APIs lies in the entire production process from the initial lab-scale to the finished product. Contaminants that are especially challenging to eliminate in the final stage must be kept to a minimum during the synthetic process. With efficient systems, waste is reduced and yields increase, and contaminants are either removed, or at least significantly diminished.

Facility

Having disinfected, clean, and fully equipped facilities are crucial because mediated signaling equipment is necessary for high-quality API production. The parts of the facility that are subjected to GMP regulations are included in quality assurance.

Indian API Industry Gaining More Attention Globally

India is a system of more than 10,500 producers and 3000 pharma businesses, making it one of the well-known, booming economies significantly for the Active Pharmaceutical Ingredients industry. Additionally, India holds a key position in the global pharma industry as being one of the biggest players in supply of generic medications with a volume customer base of 20%. Due to a sudden peak in the market for medications like Lornoxicam related to Covid-19, the exports have hiked by 18% particularly during the financial year 2021. With a customer base of nearly 35%, API has become an important sector for the Indian pharma industry.

List of API intermediates offered by DU Organics:

2-Cyclohexene-1-one

Chemical formula: C6H8O

Applications: used as Carprofen (nonsteroidal anti-inflammatory drug), used to synthesise herbicides like Clethodim and Tralkoxydim, used as a fragrance ingredient with roasted savoury green smell

Trimethoxy Dobutamine Hydrochloride

Chemical formula: C14H20O93

Applications: used to manufacture Dobutamine Hydrochloride (helps in treatment of cardiogenic shock and severe heart failure disease),

2-Amino-4-Phenyl Butane

Chemical formula: C10H15N

Applications: used to manufacture Labetalol (helps in treatment of high blood pressure and in long-term management of angina)

Benzylidene Acetone

Chemical formula: C10H10O

Applications: used to manufacture Warfarin (helps in treatment of blood clots and prevents stroke in people having atrial fibrillation, valvular heart diseases, even artificial heart valves)

4-Methoxy Benzyl Amine

Chemical formula: C8H11NO

Applications: used to manufacture Idarubicin (helps in treatment of certain cancer types), used as in intermediate of Meobetine (used as Cardiac depressant/anti-arrhythmic)

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