Category Archives: Chemistry

Challenges facing active pharmaceutical ingredient production

Active pharmaceutical ingredient (APIs) production face also of problems especially china and India.

The following are challenges facing API companies.

Pharmacie, drugs, Generic drug

Regulatory Problems

In this is inspection. When API industries are not thoroughly inspected defective products will not be detected however, this may cause life- threatening products or even ineffective commodities in the hand of the public.

The regulatory system must ensure that API production companies operates under legality however, lack of inspection will lead to defective products distributed to the public.

API production companies have failed to follow the rules and regulation passed by the regulatory board. Many industries are ignoring the public health and are motivated by greed through practicing fraud or illegality intentionally.

API production companies have faced challenges of controlling repacking and relabeling of products by other people hence duplication of API products.

Limited Approval of New Chemical Entities

In the past few years the rate of new chemical entities has declined rapidly. This is according to the research done by IMS.

The reason behind this decline due to the increase of high safety standards and scrutiny by FDA (food and drug administration authority).

Products Delays and Non-Approvals

It takes 10-12 years for a new medicine to be approved from launch to distribution

Increased generic competition

In this case big API production companies spends millions of dollars from discovery to product launch. This process takes years hence bringing delay to approval.

Technology Transfer

Technology transfer is associated with risk that require management. Transfer of technology from one culture to another is complex and more complicated due to the cultural differences of the involved sites of the organization. In this aspect technical skills are also required for the facilitation of the operation. Training and development of employee’s skills must be established in order to catch up with the new technology discovered.

Regulatory Aspects

Due to the short timeline given by the regulatory, it’s difficult to cope with the challenges of the manufacturing sit directed by the regulatory system.

Organic Chemistry and Synthetic Organic Chemistry

The differences between Organic Chemistry and Synthetic Organic Chemistry are small, but by no means insignificant. At it’s most base and simple form, Organic Chemistry describes the overall study of the properties and structures of organic compounds, and the effects had on them by various sources. While the study referred to as Synthetic Organic Chemistry generally talks more specifically about finding ways to create compounds using existing methods.

 

This can either mean creating brand new compounds or molecules that have never existed before (but have been theorized to have desirable uses and/or applications) or simply taking an existing compound or molecule and trying to find a more efficient way to create it so that it can be used more readily.

 

More Details

 

Of course saying that those are the only two uses of synthetic organic chemistry is almost insulting to the study, but they are the two main focuses, and will therefore be the focus here. Since synthetic organic chemistry is in fact a subset of the larger umbrella of “Organic Chemistry” people usually wind up studying a bit of both. However, it is theoretically possible to study organic chemistry and only have the most passing familiarity with synthetic organic chemistry.

 

So it’s not that it’s a different science, per-se, it just simply uses focuses one general aspect of the science. The building of compounds. It might be a bit boring to some people, but to others this process is endlessly fascinating. So, to clarify, this is the process of:

 

1: Mixing Compounds or Molecules

2: Adding and Repeating as Needed

3: Testing the Results Under Various Conditions

4: Making a Viable, Usable Entity at the Other End

 

This is a wonderful, useful science that is helping drive the modern world forward as we create new and exciting molecules. Or simply better ways of making stuff we already know how to make, making them more available for people and the public in general.