Category Archives: API manufacturing

Active Pharmaceutical Ingredient Manufacturing and Processing

There are several steps involved in the API manufacturing. All of these steps have to be co-ordinate carefully.

Not only that but it must be ensured that all of the API manufacturing equipments are used to their maximum efficiency. Hence maximum optimization is favored. All of this must be ensured without any compromise to the quality.

Care must be taken to ensure that the API manufacturing process takes place in a clean environment, avoid cross contamination of different APIs and maintain the requisite strength of the APIs.Molecule

The key to developing a good API lies in the raw materials chosen. Good laboratory conditions along with adherence to the health authority regulations are a must. The appropriate reactor must be chose along with a purification method that delivers the maximum throughput.

Roughly speaking the  various steps involved in API manufacturing are:

  • Selection of raw materials- the necessary raw materials of appropriate quantities must be selected. These comprise the starting materials.
  • Reactor- the raw materials are treated in a reactor under the optimal conditions to obtain the intermediate products.
  • Purification- now the intermediates are isolated and purified to obtain individual products. This involves a variety of purification techniques including, filtration, sedimentation, crystallization, and centrifugation and so on.
  • Standards- the products that are obtained as a result are checked for their strength. Each pharmaceutical company employs different standards to measure the strength of its API.
  • Packaging –finally the products are milled and packaged carefully.

The API manufactured is the incorporated or integrated with the transport agent, which is responsible for the drug’s delivery into our systems. We have to make sure that the API is agreeable with the inactive material chosen. Once more the drug is tested before distribution on a commercial scale.

Chemistry

Future of API manufacturin

Consistently, expansive pharmaceutical suppliers can eject anywhere in the range of 3000 to 5000 tons of unsafe industrial wastes eachIf someone ask any legitimate API producer how they might want to improve the procedure?, they’d likely say by speeding up the responses, or by minimizing expensive. The unexpectedlyanswer to that question is diminishing waste from API amalgamation would be to decrease the quantity of responses required to reject that outer particles Today there are in everywhere louder calls for API manufacturing to make big strides toward environmental friendliness – that is to say, to decrease the waste they create…,

In spite of howdistinctive is the objective might be, theyalways ends up with useless solutionof the same as less responses idea which meansnon-solution at all. Butglimmer of hope to solve this problem has been in horizon by putting forward brilliant idea environmentally friendly which is to discover effective solutions and impetuses that are more productive, as well as better for the planet.

scientist

What is the future of API manufacturing?  

By effortlessly search you will find many of known API manufacturing firms which aremoving far from multifunctional instils and rather than they choosing practice at in particular locales. Then, there will serious concerns on how come can they monitored? Especially after each of API made by one organization, in one nation, with the excipient made in another by an alternate organization, then merged and circulated to another organization inside and out makes this case somewhat difficult to becontrolled or over sighted.

The running development in new restorative innovations is inducing the APIsinterest overall today particularly with the expanded importation of crude pharmaceutical fixings from developing markets a recent consideredstudy concluded that nations like India and China, which now supply more than 40% of APIs utilized as a part of the U.S. will doubled that figure to an incredible 80% in only the following 10 years.

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.

An Example for API manufacturing

There are several types of API manufacturing in present days

Almost every antidote which is biologically synthesized contains Active Pharmaceutical Ingredient in it. There are used in almost every field of pharmacy and especially in herbal treatment. One such example is Gemfibrozil API manufacturing which is a drug used for lowering lipid levels. Lipids are fat layers present under the skin which determines the amount of cholesterol present in our body. People who are obese are prescribed to take this API. It belongs to the drug family of fibrates and this API is manufactured.

This API is an activator of Peroxisome  proliferator-activated receptor – alpha (PPARA) which is a nuclear receptor related directly to the synthesis of carbohydrates and fat. It is proven to be effective in adipose tissue differentiation.

When taken as recommended it results in the reduction of triglyceride levels and very low lipoprotein (VLDL) and a reduction of a less magnitude of LDL levels. It results in the level increase of high-density lipoprotein (HDL) levels. Normal medication dosage of gemfibrozil is 600 mg a short while after breakfast.

Some precautions while taking these drugs are given here. Those who are suffering from kidney failure must not take this.

People with diabetes must also avoid this because intake of these drugs may lead to a rise in insulin levels. This drug may lead to side effects like gallstones, hypokalemia and even cancer also. So these drugs are better to be avoided in case of a longer medication situation.    

Like Gemfibrozil, there are several kinds of API manufacturing like Venlafaxine which is used as an anti-depressant, Carbidopa API manufacturing which is used for the treatment of Parkinson’s disease which affects the key areas of the brain, Diltiazem API which is used for cardiovascular diseases and many more. These make the pharmaceutical industry go leaps and bounds in curing millions of people.