What is an Active Pharmaceutical Ingredient or API?

What is an Active Pharmaceutical Ingredient or API?

Active Pharmaceutical Ingredients or APIs are the raw materials used for making formulations or medicines that we intake to cure various diseases. It’s biologically active and has therapeutical effects when manufactured with precision adhering to WHO-specified parameters and other standard manufacturing practices. Besides China, India is one of the largest API producers in the international pharmaceutical market.

Furthermore, USD 4-5 billion is invested in India for API manufacturing and supplying with an expected growth of CAGR 13.7% (1). Top national and international pharmaceutical companies prefer to procure from our country due to its quality efficacy, commercial value, and complete regulatory documentation support. To know more about what is Active Pharmaceutical Ingredients, top API suppliers in India, how API determines the strength of medicines and a lot more read here.

Components of a drug – API & Excipients API & excipients are two main components of a drug or medicine. 

API – It has the chemical concentration and necessary strength to fight against diseases through its mechanism of action.

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Excipient – It includes other ingredients than the API that makes a final dosage of medicine. It helps the main medicine to get absorbed by your system and work rapidly.

The third type is intermediates, which is the intermediate substance between the chemical raw material and the API. Hence, next time you wonder what is what is Active Pharmaceutical Ingredients and how it cures health conditions then just remember to read this blog again to clarify your questions.

Jatan Exports is one of the leading API suppliers in India that shoulders the global endeavour to expedite the production of medicine in providing the fastest recovery to patients. Additionally, we want to enhance the awareness of the common people about various diseases, precautions, and safe intake of medicines with doctors’ advice.

Functions of various pharmacopeia in API & way to check it A pharmacopeia determines the eligibility of an API to use in a specific country as it binds the legal collection of quality standards under the Drug and Cosmetic Act 1940.

It is highly necessary for the regulatory control of drugs.

If you want to know what is Active Pharmaceutical Ingredients’ pharmacopeia then check the Drug Fact label on the back side of the medicine.

Various types of Pharmacopeia are: USP or United State Pharmacopeia – It’s National Formulary (USP-NF) or compendium of drug information that includes more than 5000 standard quality parameters for chemical and biological APIs. EP or European Pharmacopeia – It’s specific quality standards for European pharmaceutical companies.

BP or British Pharmacopeia – It’s specific quality standards for British or pharmaceutical companies in the UK. IP or Indian Pharmacopeia – It’s specific quality standards for Indian pharmaceutical companies.

JP or Japanese Pharmacopeia – It’s specific quality standards for Indian pharmaceutical companies.

Jatan Exports has an active product supply list that has API of USP, BP, EP, and IP. Hence, it’s competent to export API across the world and also supply to the domestic market.

What are regulatory documents for an API and why it’s required?

Regulatory documents ensure that the API is manufactured complying with the quality standard practice as unsafe API can result in harmful medicine. Various regulatory documents for an API are: 

GMP or Goods Manufacturing Practice – It ensures the quality and traceability of the process of the medicine manufacturing process.

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DMF or Drug Master File – It is a submission to the Food and Drug Administration to provide detail about facilities, procedures, articles, processing, packaging, and storing of human drug API.

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The root of Synthesis – It’s a description of the synthetic route or the subsequent steps in combining smaller or less complex bulk chemicals into API.

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COA or Certificate of Analysis – It’s a detailed point-wise parameter of analytical facts about the API.

Besides, there are various other documents to ensure the quality of API. Top pharmaceutical companies rely on Jatan Exports for sourcing API as we can provide all regulatory documents along with API supply from India. Precison, qulaity, timely delivery, excljsive freight,a nd packaging support are our unique selling points.

Why should you check the API before taking a medicine?

You should check the name of the API before taking medicine to know what therapeutic material you are taking for your specific condition. Often, medicines are sold under a marketed brand name and not in the name of the actual API. For eg, the doctor prescribes Duexis for arthritis; however, Ibuprofen is its API content.

If you know what Active Pharmaceutical Ingredients you are taking then you can check various webpages or our website to know the mechanism of action of Ibuprofen. In case, you are taking over-the-counter medicines then you must be aware of their dosage, side effects, contraindication, and a lot more.

Although you can read all these on Jatan Export’s website even though, we advise you to consult a doctor and take medicines according to their advice.

Which are the top 3 countries manufacturing and supplying API? The top 3 countries manufacturing API are:

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India China USA

China is one of the largest API suppliers in the world; however, Indian API export is in the second position and has high demand due to its quality factors. Indian Government with niche pharmaceutical market leaders like Dr. Reddy’s, Sun Pharma, Cipla, etc. are investing and concentrating on higher production of API at an effective cost.

Within a very short period, Jatan Exports has created fame in the Indian API suppliers and traders list. We have supplied quality API with regulatory document support to the world’s leading pharmaceutical companies. Our team of industry experts, digital reach, quality assurance, and vast product list have set us on the priority list of international API buyers.

A word from Jatan Exports on Active Pharmaceutical Ingredients Pharmacology is an untapped resource that can provide you with a wealth of information. Hence, to know what is Active Pharmaceutical Ingredient, its interactions, benefits, precautions, efficacy, and compliances read our blog section and product descriptions to enrich your information jackpot in a simplified approach.