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Outsourcing of API Manufacturing – Are Strict Regulation and Quality Checks Necessary?

Views: 113     Author: Site Editor     Publish Time: 2021-12-21      Origin: Site

There are so many diseases that affect the human population in the current hours and so are the numerous drugs that are available to treat those diseases. Any drug aimed at treating a disease or its symptoms is made from 2 basic ingredients.


One of the ingredients is the central ingredient that needs to be administered for producing the desired results and the other ingredient is an excipient that helps in the delivery of the main ingredient in our system. Common excipients are mineral oils or lactose and they remain chemically inactive in any drug.


The central ingredient is referred to as API or Active Pharmaceutical Ingredient. There can be a single API or multiple in any drug combination. Manufacturing the right strength and potency of a drug is imperative for any pharmaceutical organization as these factors are strictly regulated by FDA and are monitored by very stringent quality control parameters.


Sandoo Pharmaceuticals from China have a reputation in the pharmaceutical industry. This pharmaceutical organization is regarded as a very reputed API manufacturer and they have R&D facilities that are fully equipped with modern pharmaceutical equipment. Maintaining a high level of quality and integrity in their production line is the basis on which this organization works to provide advanced pharmaceutical solutions to the world.


Examples of API

As we have learned that API is the effective part of any medicine that needs to be administered to cure treat a specific disease in the body. To better understand the terminology let us take an example of a very common medicine that we all have consumed multiple times in our life, Paracetamol.


Alone paracetamol cannot form a stable drug that can be sealed in a capsule, packaged, shipped, and stored. Every medicine needs a carrying agent which remains inactive in the drug. Some carrying agents can impart volume to the drug while others are added for altering the taste. However, it is the main ingredient paracetamol, which will be delivered to the body to provide a reduction in inflammation and fever.


Therefore, paracetamol is the API of the drug Paracetamol. However, some drugs may not have the same name as their API ingredient. For example, the API acetylsalicylic acid is found in the drug, Aspirin.


Production of API

In early times, it was the pharmaceutical industry that was responsible for doing research on various drugs, manufacturing the APIs, and production and distribution of medicines worldwide.

The scenario has changed widely nowadays. API manufacturers are now located in labor-intensive countries like China where it is easier to set up large production plants and lower labor costs help in cutting down the production cost as well.


As China is also the source of most raw materials for producing APIs, it is a hub of most API manufacturing plants across the globe.

Producing an API is a multi-step process and most APIs are produced as a powder, which is then sold to various multinational drug manufacturers who then add excipient to produce a stable form of a drug that can be packaged and sold.


Regulations on API manufacturing

Since, an API is the major ingredient of a drug that can alter the efficacy and safety parameters of any medicine, maintaining strict quality becomes imperative. This is why there are many regulations placed by the FDA on the manufacturing of API ingredients of any drug.


Additionally, an API manufacturer is generally not located in the same country as the pharmaceutical organization. This is necessary to cut costs. This makes maintaining stringent checks on quality control of API production even more necessary.


An API needs to pass quality checks at two major levels:

  1. In the country where it is produced.

  2. In the country where drugs are manufactured and are sold to end-users.


This is why an API manufacturer has to arrange for 3rd party audits whose certification ascertains that all industry standards are followed during the manufacturing process of an API in their industrial setup.


In case, a company fails the inspection process, they are issued a warning and all dealings with drug manufacturers are temporarily put on hold until they pass re-inspection audits. This is done to ensure that all APIs are safe for human use and the consumption should not lead to any ill-effects that can cause serious illness and even death in some cases.


There are multi-level checks of batches of API produced:

  • Firstly, it will be analyzed by the laboratory of the API manufacturer itself.

  • Secondly, 3rd party laboratory will conduct an inspection of the safety and quality parameters of the API manufactured.

  • Thirdly, the drug manufacturer or pharmaceutical company will test the API before trading.

  • Lastly, many batches will also be tested by the hospitals where the drug will be prescribed to the end-users.

  • Product categories that fall under the API regulatory control are:

  • Generic products with/without scheduled poison.

  • New drug products.

Health supplements, veterinary products, biotechnology products, and traditional products do not come under API regulatory control.


Good manufacturing practices

This is the term that most API manufacturers have to abide by. These are the standards that are internationally recognized to produce safe API for manufacturing a drug. Every country has a set of regulations set in place which contains all the guidelines that an API manufacturer must follow as a part of GMP.


Finding a reputable API manufacturer who follows GMP very strictly is a must if we want to assure that the drugs that are manufactured in the pharmaceutical industry are safe for human administration. Some of the parameters that can determine the reputation of API suppliers are:

  • A background check should be able to reveal any loopholes in their manufacturing processes, their turnover, capacity to the manufacturer, and their past client history.

  • Checking the records of quality parameters followed while procuring raw materials, manufacturing API, storing and packaging of the API ingredient.

  • Also, confirm whether the API supplier is ready to take responsibility for any failed quality check or not.

  • Their readiness to produce an API in a specific time frame speaks a lot about their efficacy as an API manufacturer.

API is fundamental to the modern drug manufacturing process and cutting cost should not be the only criteria that can be applied to the production of an active pharmaceutical ingredient as it can adversely affect human health if the above-mentioned regulations and practices are not followed strictly.


There are so many diseases that affect the human population in the current hours and so are the numerous drugs that are available to treat those diseases. Any drug aimed at treating a disease or its symptoms is made from 2 basic ingredients.


One of the ingredients is the central ingredient that needs to be administered for producing the desired results and the other ingredient is an excipient that helps in the delivery of the main ingredient in our system. Common excipients are mineral oils or lactose and they remain chemically inactive in any drug.


The central ingredient is referred to as API or Active Pharmaceutical Ingredient. There can be a single API or multiple in any drug combination. Manufacturing the right strength and potency of a drug is imperative for any pharmaceutical organization as these factors are strictly regulated by FDA and are monitored by very stringent quality control parameters.


Sandoo Pharmaceuticals from China have a reputation in the pharmaceutical industry. This pharmaceutical organization is regarded as a very reputed API manufacturer and they have R&D facilities that are fully equipped with modern pharmaceutical equipment. Maintaining a high level of quality and integrity in their production line is the basis on which this organization works to provide advanced pharmaceutical solutions to the world.


Examples of API

As we have learned that API is the effective part of any medicine that needs to be administered to cure treat a specific disease in the body. To better understand the terminology let us take an example of a very common medicine that we all have consumed multiple times in our life, Paracetamol.


Alone paracetamol cannot form a stable drug that can be sealed in a capsule, packaged, shipped, and stored. Every medicine needs a carrying agent which remains inactive in the drug. Some carrying agents can impart volume to the drug while others are added for altering the taste. However, it is the main ingredient paracetamol, which will be delivered to the body to provide a reduction in inflammation and fever.


Therefore, paracetamol is the API of the drug Paracetamol. However, some drugs may not have the same name as their API ingredient. For example, the API acetylsalicylic acid is found in the drug, Aspirin.


Production of API

In early times, it was the pharmaceutical industry that was responsible for doing research on various drugs, manufacturing the APIs, and production and distribution of medicines worldwide.


The scenario has changed widely nowadays. API manufacturers are now located in labor-intensive countries like China where it is easier to set up large production plants and lower labor costs help in cutting down the production cost as well.


As China is also the source of most raw materials for producing APIs, it is a hub of most API manufacturing plants across the globe.

Producing an API is a multi-step process and most APIs are produced as a powder, which is then sold to various multinational drug manufacturers who then add excipient to produce a stable form of a drug that can be packaged and sold.


Regulations on API manufacturing

Since, an API is the major ingredient of a drug that can alter the efficacy and safety parameters of any medicine, maintaining strict quality becomes imperative. This is why there are many regulations placed by the FDA on the manufacturing of API ingredients of any drug.


Additionally, an API manufacturer is generally not located in the same country as the pharmaceutical organization. This is necessary to cut costs. This makes maintaining stringent checks on quality control of API production even more necessary.


An API needs to pass quality checks at two major levels:

1. In the country where it is produced.

2. In the country where drugs are manufactured and are sold to end-users.

This is why an API manufacturer has to arrange for 3rd party audits whose certification ascertains that all industry standards are followed during the manufacturing process of an API in their industrial setup.


In case, a company fails the inspection process, they are issued a warning and all dealings with drug manufacturers are temporarily put on hold until they pass re-inspection audits. This is done to ensure that all APIs are safe for human use and the consumption should not lead to any ill-effects that can cause serious illness and even death in some cases.

There are multi-level checks of batches of API produced:

  • Firstly, it will be analyzed by the laboratory of the API manufacturer itself.

  • Secondly, 3rd party laboratory will conduct an inspection of the safety and quality parameters of the API manufactured.

  • Thirdly, the drug manufacturer or pharmaceutical company will test the API before trading.

  • Lastly, many batches will also be tested by the hospitals where the drug will be prescribed to the end-users.

  • Product categories that fall under the API regulatory control are:

  • Generic products with/without scheduled poison.

  • New drug products.

Health supplements, veterinary products, biotechnology products, and traditional products do not come under API regulatory control.


Good manufacturing practices

This is the term that most API manufacturers have to abide by. These are the standards that are internationally recognized to produce safe API for manufacturing a drug. Every country has a set of regulations set in place which contains all the guidelines that an API manufacturer must follow as a part of GMP.


Finding a reputable API manufacturer who follows GMP very strictly is a must if we want to assure that the drugs that are manufactured in the pharmaceutical industry are safe for human administration. Some of the parameters that can determine the reputation of API suppliers are:

  • A background check should be able to reveal any loopholes in their manufacturing processes, their turnover, capacity to the manufacturer, and their past client history.

  • Checking the records of quality parameters followed while procuring raw materials, manufacturing API, storing and packaging of the API ingredient.

  • Also, confirm whether the API supplier is ready to take responsibility for any failed quality check or not.

  • Their readiness to produce an API in a specific time frame speaks a lot about their efficacy as an API manufacturer.


API is fundamental to the modern drug manufacturing process and cutting cost should not be the only criteria that can be applied to the production of an active pharmaceutical ingredient as it can adversely affect human health if the above-mentioned regulations and practices are not followed strictly.






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