Api pharmaceutical

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Api pharmaceutical

The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies. Aurobindo and Cipla manufacture APIs each, exporting their products to well over countries worldwide. This has led to more and more companies to outsource API manufacturing to such places, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure — which on top of everything can also be complicated to install and maintain.

Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used. For instance, sincethe FDA has considerably increased its overseas staff as a way of attempting to eliminate these problems. As a result, countries such as India have gained their foothold in the global market and now have around 75 FDA-approved manufacturing facilities for API synthesis. Today there are more and more calls for API manufacturers to go green — that is to say, to reduce the waste they produce.

Taiwan's API Manufacturers- Top Choices for Global Pharmaceutical Companies

Every year, large pharmaceutical manufacturers can produce anywhere from to tons of hazardous waste each. Ironically the first steps in reducing waste from API synthesis would be to reduce the number of reactions required to produce a given molecule.

Therefore though the goal may be different, the means turn out to be the same as fewer reactions mean less solvent to dispose of. Another step in going green is to find different solvents and catalysts that are not only more efficient, but are also better for the environment.

api pharmaceutical

Major API manufacturers such as Merck, AstraZeneca and GlaxoSmithKline are also moving away from multifunctional plants and instead opting for specific activities at specific sites. In this way, there are serious concerns as to how any centralized control could function as after all an API manufactured by one company, in one country, with the excipient manufactured in another by a different company, then packaged and distributed by another company altogether makes the route rather difficult to monitor or control.

The current growth in new medical technologies is spurring the demand for APIs worldwide today especially with the increased importation of raw pharmaceutical ingredients from emerging markets. Venlafaxine is an anti-depressant of the SNRI serotonin-norepinephrine reuptake inhibitor class. It works primarily by altering chemical levels in the brain that may become unbalanced thereby causing depression.

Marketed under the brand name Effexor it is administered as an extended-release capsule containing venlafaxine hydrochloride. As well as being prescribed for depression it is also used to treat anxiety and panic disorders. Init was the sixth most commonly prescribed drug for depressive problems.

It is either a white or off-white crystalline sold that is structurally and pharmacologically similar to the opioid analgesic tramadol.Certain drugs are comprised of more than one kind of API. Any drug is composed of two components or aspects. The second is known as an excipient.

This refers to the substance inside the drug or tablet. If it is in syrup form, then the excipient will be the liquid that has been used. Thus, excipients are the inactive or inert substances present inside a drug while the Active Pharmaceutical Ingredients is the chemically active substance, which is meant to produce the desired effect in the body.

Certain Active Pharmaceutical Ingredients are unknown and hence require additional substances, which can work in conjunction with the API to produce the required medicinal effect. For example, in the case of herbal medicines, the API is usually a combination of several mixtures and substances, which when used together become active and act on the body.

Thus, in such situations, the Active Pharmaceutical Ingredients are not singular substances but the culmination of several herbs and ingredients. Manufacturers usually use certain standards and benchmarks of calculation in order to determine the relative strength of Active Pharmaceutical Ingredients inside a medicine or drug.

However, the methods of standardizing the strengths of APIs within a medicine differ from one brand to another. While one manufacturer may use a certain standard for evaluating the strength of Active Pharmaceutical Ingredientsanother manufacturer may use a different standard altogether. As described above, in the case of herbal medicines the Active Pharmaceutical Ingredients are a combination of several different substances. According to the particular herbal supplement the active ingredient will differ significantly.

Since Active Pharmaceutical Ingredients are used in different proportions for virtually all the herbal medicines, suppliers procure poor quality batches of such Active Pharmaceutical Ingredients. By poor quality, it means that the strength of the API is lesser than what it should be. This automatically entails that the resultant herbal medicine does not combine the full properties of the Active Pharmaceutical Ingredients as it ideally should.

When contacting Active Pharmaceutical Ingredients suppliers it is essential to ensure high quality of the substances. In addition, the documentation, regulatory compliance, storage of Active Pharmaceutical Ingredients as well as packaging, labeling, repackaging, release and production should all be as per the standards set by the FDA. Client confidentiality is critical and suppliers need to maintain complete confidentiality while dealing with their clients. The supplier should have a suitable system to accept or reject all intermediate materials, raw materials, labeling or packaging materials as per their discretion.

All the manufacturing records must be thoroughly evaluated to ascertain all the important process steps have been followed. Only then should the Active Pharmaceutical Ingredients be released.

Active Ingredients:. Components of a drug Any drug is composed of two components or aspects. Complementary substances for added benefit Certain Active Pharmaceutical Ingredients are unknown and hence require additional substances, which can work in conjunction with the API to produce the required medicinal effect.

Strength of API Manufacturers usually use certain standards and benchmarks of calculation in order to determine the relative strength of Active Pharmaceutical Ingredients inside a medicine or drug. Herbal medicines prone to bad quality As described above, in the case of herbal medicines the Active Pharmaceutical Ingredients are a combination of several different substances. High quality is essential When contacting Active Pharmaceutical Ingredients suppliers it is essential to ensure high quality of the substances.

Andre Waismann. Active Pharmaceutical Ingredients. Olmesartan Medoxomil.Z 2-Formylaminothiazolyl met E -1,4,5,6-tetrahydromethyl[2- 3-m NH3 2PtI2. R 2- 2,5-dichlorobenzamido acetamido R Cyanohydroxybutyric acid ethyl ester. R -dimethyl 1-methyloxo-3,3-diphenylh R -piperidinaMine.

S -1,2,3,4-TetrahydroIsoquinolinecarb As an active pharmaceutical ingredient and intermediate supplier, Parchem takes pride in providing a wide range of high quality pharmaceutical materials at competitive market prices.

We work closely with API manufacturers and custom formulators to ensure that the active pharmaceutical ingredients you require are readily available. Parchem is proud to represent the best custom manufacturers of active pharmaceutical ingredients with high production capabilities, and we will gladly work with you to develop your API and chemical business. Active pharmaceutical ingredients from a chemical supplier like Parchem are chosen for the quality and ready availability of the API.

These materials are often combined with the quality excipients, binders, and tableting aids supplied by Parchem. Finding all the materials you need to develop your product has never been easier than with Parchem at your side. API chemicals supplied by Parchem can be found in countless pharmaceuticals manufactured by major companies all over the world. Major pharmaceutical manufacturers turn to Parchem for their APIs because of our commitment to quality, efficiency, and reliability.

Our relationships with active pharmaceutical ingredient manufacturers ensure that Parchem is consistently the best resource for the materials you require. We are able to remain highly competitive in the API chemical marketplace because we offer the full range of services from sales and customer service to domestic warehousing and international logistics. Parchem is able to bring active pharmaceutical ingredients to you anywhere in the world, and our commitment to quality ensures that you get the product you need in a timeframe you can count on.

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Enter a chemical name, synonym or CAS below to search. Product Name.

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View Details. Add to quote. Get A Quick Quote. Showing 1 - 8 of products available. Results Per Page 20 40 80 All. Looking for another product?Active pharmaceutical ingredient APIis the term used to refer to the biologically active component of a drug product e.

Drug products are usually composed of several components. The aforementioned API is the primary ingredient. Other ingredients are commonly known as "excipients" and these substances are always required to be biologically safe, often making up a variable fraction of the drug product.

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The procedure for optimizing and compositing this mixture of components used in the drug is known as "formulation". For example, if the API is a solid and the drug is required to have a liquid dosage form, such as a cough syrup, then the excipients would be the liquids that are used to formulate the syrup.

api pharmaceutical

The design criteria for any small molecule API is usually a combination of several factors that goes beyond the intended therapeutic effect, and usually heavily encompasses both pharmacokinetic and pharmacodynamic considerations, so for this reason, API molecules have many chemical functional groups. The API form that is used in a formulation is often the most thermodynamically stable crystalline form.

As such, the phenomenon of hydrogen bonding in combination with there being many functional groups on the API usually results in the available crystalline form being a hydrate. Because of this fact the hydration behavior of crystalline APIs is of particularly high importance within the pharmaceutical industry, and is vastly studied from every possible angle. The state of hydration has a direct effect on the physical properties of the API, which in turn has a large impact on the drug processability and how the drug will eventually perform in-vivo, i.

Recently, a team of scientists in the department of Drug Product Science and Technology, at Bristol-Myers Squibb, USA have developed a supplementary technique to complement more conventional analysis methods such as calorimetric studies, nuclear magnetic resonance and vibrational spectroscopy to study the behavior of hydration in organic crystalline solids.

By performing single crystal X-ray diffraction experiments with the ultimate objective being interpretation of the non-Bragg diffraction features, Chan et al, Acta Cryst. B70, were able to gain further insight into the mechanical and structural details of the dehydration of the crystal.

Understanding active pharmaceutical ingredients

These scattering features were reproduced and studied using computer models and the results were able to show the mechanistic relationships between changes in the lattice structure as stages of the overall drying process.

This study is the first of its kind to combine the mechanism of dehydration and non-Bragg scattering features from a single API crystal and the results will further improve the knowledge, formulation and choice of API used in drug manufacture today. The group at BMS anticipates that these same data interpretation techniques will be useful to other researchers and that a more user friendly modeling software can be made available in the future.

Explore further. More from Chemistry. Your feedback will go directly to Science X editors. Thank you for taking your time to send in your valued opinion to Science X editors. You can be assured our editors closely monitor every feedback sent and will take appropriate actions. Your opinions are important to us. We do not guarantee individual replies due to extremely high volume of correspondence.We began producing Active Pharmaceutical Ingredients APIs in as a vital input in the manufacture of complex formulations and products to facilitate complete vertical integration.

Today, our list of APIs exceeds which is used for captive purposes as well as marketed to customers in over 60 countries across the world. We are trusted partners for many leading global generic and innovator companies. Our product list includes generics and complex APIs that require isolated manufacturing areas, like anti-cancers, peptides, steroids, sex hormones and controlled substances, including poppy-derived opiate raw materials that are primarily used in the manufacture of analgesics, sold as both Narcotic Raw Materials NRM and API's.

We offer Bulk Actives, Intermediates and services for Custom Synthesis providing an integrated solution for the diverse requirements of generic and innovator companies. These manufacturing facilities have been certified as complying with Current Good Manufacturing Practices cGMP by several global regulatory agencies. Our comprehensive end-to-end support ensures smooth development, timely filing and successful launch of products. We pride in offering customers an unmatched advantage to develop and file their products in time with regulators across the globe.

We have an experienced team of IP attorneys and other skilled professionals, specialising in related fields of science and IP law, working diligently to protect our IP wealth.

The team ensures that all APIs, drug products and processes developed for various global markets comply with applicable laws. Disclaimer: Products protected under valid patents are not offered or supplied for commercial use.

However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.

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Login Join. Subscribe Free Magazine eNewsletter. George Karris T he role of active pharmaceutical ingredient API manufacturers in the pharmaceutical industry supply chain is evolving in response to newfound demands from customers and growing pressures from global competitors.

Increasingly, innovators marketers of brand drugs, as opposed to generic drug companies are looking beyond their usual group of closely-knit European suppliers.

api pharmaceutical

Meanwhile, traditional generic companies are looking to India and China for bulk actives, while specialty pharma companies have generated new demands for more specialized capabilities than those required by traditional generics.

In order to remain competitive, API manufacturers will need to attune themselves to this evolving landscape. Historically, innovators have relied on a small number of suppliers with which they work confidentially. Innovators frequently opt to perform the final stages of API synthesis themselves, outsourcing at most the production of late stage intermediates. While this pattern continues to predominate, innovators have begun to look beyond their current European suppliers to realize benefits from partnerships with Indian and Chinese API manufacturers.

In many cases the opportunity to leverage existing European relationships with Indian process chemistry can create a more complex, but ultimately more responsive and cost-effective supply chain. Solvay's first source for eprosartan is Lonza, a Swiss company known for high quality custom synthesis, and one that has long been known for supplying innovators. However, Solvay also performed process development work in India with a relatively obscure API manufacturer known as Dishman Pharmaceuticals and Chemicals, which ultimately ended up serving as a second source for Solvay.

Solvay executives claimed that working in India helped the company achieve significant cost savings and, as a result, Dishman, a company that had one drug master file DMF as ofis now a second source of an important new product.

Several factors make India an attractive alternative for sourcing active ingredients. India has low development costs, complex synthesis capabilities, growing experience with cGMP compliance, and a large local dose market in which to gain experience.

India is also known for having a large number of strong chemists, many with Ph. With these resources, Indian companies can tackle complex syntheses in relatively short periods of time. Such responsive and well-staffed development teams have prompted Reddy-Cheminor, for example, to claim a development speed twice that of any U.

api pharmaceutical

Further, India's lax patent laws have resulted in strong domestic demand for many finished dose products, giving API and dose form manufacturers more experience with a product over a longer period of time than manufacturers in regulated countries. In fact, new drugs are often launched early, if not first, in India. Thus, India has established itself as a source for both complex synthetic active ingredients and finished dose form products in regulated and unregulated markets.

China is also rapidly evolving into a viable source for key intermediates and actives. In the late s and early s, most Chinese factories were communist-controlled, and made large volumes of low cost drugs, with many focusing on fermentation products or simple synthetic compounds.Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.

Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.

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All drugs are made up of two core components: the API, which is the central ingredient, and the excipient, the substances other than the drug that helps deliver the medication to your system.

Excipients are chemically inactive substances, such as lactose or mineral oil in the pill.

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Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. Each brand might use different test methods, that can result in different potencies. In all cases, manufacturers are required by the FDA to prove the potency of their products in real-life patients, as well as in laboratory conditions.

With over API products, they have the industry's largest portfolio. Another leading manufacturer is Dr. Reddy's, with more than 60 APIs in use today. Each of these companies specializes in different APIs, with some offering generic products as well.

While many pharmaceutical companies are located in the United States and England, most API manufacturers are overseas. The largest are located in Asia, particularly in India and China. More and more companies are outsourcing to cut costs on expensive equipment, employees, and infrastructure. While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.

Notably, AstraZeneca Pharmaceuticals used to operate several manufacturing centers in the United States. The quality of APIs has a significant effect on the efficacy producing the result desired and the safety of medications.

Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses or death. Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to.

As evidenced by the creation of APIs, the pharmaceutical industry is rapidly changing. Companies no longer handle every step of the drug-making process. One company used to create the API, build the capsule, and package the medicine—but no longer.

In response, governing bodies responsible for patient and public safety have instituted intense screenings to ensure medication quality and prevent defects. Violating any of these established standards can result in fines or very expensive recall for the pharmaceutical companies behind these manufacturers.

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