Active Pharmaceutical Ingredient Manufacturing

Posted by admin on October 26, 2016 in Uncategorized |

A majority of active pharmaceutical ingredient companies are to be found in England, the United States

of America. However, other manufacturers are located in other countries too with the largest

manufacturers being in Asia, particularly in India and China.

The emergence of new companies has seen them reduced to outsourcing services to more established

active pharmaceutical ingredient companies in order to;

 Meet demand in their countries

 Cut down on production costs.

 Cut down costs on infrastructure and workforce

Many of these new active pharmaceutical ingredient companies have got neither the capacity nor the

equipment to carry out the rather delicate production process. Effective API production requires well

trained, experienced and qualified staff. This remains a great challenge to new companies.

Certainly, we are bound to see more of the outsourcing business. Big and established active

pharmaceutical ingredient manufacturing companies, therefore, have got a lot to do to ensure that they

employ the required safety measures in order to keep their credibility in place.

In the United States, there has been a constant low percentage of the API manufacturing companies being

established. As a result of this, plans are underway to do away with that trend through outsourcing all the

API manufacturing work overseas.

API management

The safety and effectiveness of medication are highly dependent on the quality of the API used in the

production. While APIs are vital in medication production, poor API handling and or manufacturing can

be detrimental to health and eventually cause serious illness or worse, death.

It is, for this reason that strict measures must be adhered to in all the countries that are either

manufacturing or outsourcing. In the US for example, the US Food & Drug Administration is very active

in inspecting and evaluation to making sure all set measures have been strictly followed. If companies

violate the set rules, causes big losses and even fines to the manufacturing companies.

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