Active pharmaceutical Ingredient Supplies
Cost-Effective High Quality API Sourcing
The API or Active Pharmaceutical Ingredient is the pharmacologically active compound that treats the disease. APIs are the most expensive part of a drug product and so it is not surprising, given the ever-increasing downward pressure on drug prices, that manufacturers have sought ever-cheaper suppliers for their API.
Sadly, these conflicting interests have led to failures in quality and patients have suffered dramatically because of this. In other cases, where manufacturers have failed to meet the quality standards required by FDA, EMA and Health Canada for example, supplies have stopped. Drug shortages then occur and again the patient suffers.
This is why it is essential, from the very beginning of the development process, to obtain your API from reliable, experienced and ethical companies, which guarantee consistently high quality APIs for your new generic and value-added medicines .
How can Altus Drug Development Help you?
Altus Drug Development can help you find skilled and cost-efficient contract synthesis labs to provide the amounts of your NCE you need to progress from the Lab to the Clinic. Altus will leverage the tax advantages it enjoys in Canada to maximize the value of your investment in your NCE.
Altus can source research, development and even commercial supplies of the API you need for creation of new generic and value-added medicines.
Additional API and Drug Product Services
Altus can provide the comparator drug (Reference Listed Drug or RLD) you need for your bioequivalence studies and supply the reference standards needed for your analytical methods.
Reliability and Ethics in all our API sourcing
Altus only works with reputable and well-regulated suppliers to provide the API you need at the right quality and the right price. Our API suppliers meet the strict requirements set down by regulators such as FDA or EMA inspected and approved, which leads to a reliable product for your manufacturing needs that conforms to Good Manufacturing Practices (GMP).
Discover More About Active Pharmaceutical Ingredient (API) Supplies
Learn more about Altus Value Added Medicines
FAQs about Active Pharmaceutical Ingredient (API) Supplies
What is the composition of a pharmaceutical drug?
Drugs (or more accurately drug products) such as tablets, capsules injections, eye drops and creams are made up of two components: an active ingredient and an excipient.
- The APIs or Active Pharmaceutical Ingredients, which are the pharmacologically active compounds that treat a disease. APIs cannot be administered to humans directly.
- Excipients. These are the inactive materials mixed with the API in order to generate a readily administrable form to be given to humans. Altus Technologies contain novel excipients that can enable and improve the delivery and value of an API.
APIs are potent and potentially toxic molecules that are given to sick patients. It is essential then that the manufacture of the API must be strictly controlled, and that its quality be exceptionally high.
Where are Active Pharmaceutical Ingredients made?
Given the high cost of setting up an API manufacturing facility, the majority of pharmaceutical companies outsource their API manufacturing to contract manufacturing organizations or CMO. Again, because of the cost, there has been a strong growth in overseas API manufacturers. The largest regional producer of APIs is now Asia.
Although outsourcing to these has helped pharmaceutical companies to reduce the development and production costs for their API, there have been increasing concerns over the quality of APIs from some countries in the region. Recent concerns over melamine and nitrosamine contamination of API have resulted, for example in FDA embargoing supplies from certain manufacturers. It is essential when selecting your API supplier to ensure they comply with the strict regulations controlling the purity of their supplies.
What is the challenge of API supply today?
There has been a noticeable downward pressure on drug prices in recent years, which pushed drug manufacturers to look for cheap options of API suppliers. This has created a paradox: pharmaceutical companies are looking for cheaper sources for their APIs, but the APIs are potentially dangerous molecules that need to be of the highest quality and must be strictly controlled.
These incompatible objectives have led to a decrease and failures in quality which in turn affected the most important group: the patients. Equally problematic, some manufacturers have failed to produce high quality APIs so the supply chain stopped entirely, creating shortages of certain drugs that again negatively affected the health of patients around the world.
What are the differences between GMP and non-GMP products?
Good Manufacturing Practice (GMP) oversees products intended for clinical use. It covers the entire manufacturing process of the drug and gives regulatory bodies such as the FDA reasonable assurance that high standards of quality and safety were maintained through the various stages of development. It provides manufacturers with clear methods when it comes to testing the installations where the drug is produced, the equipment used and so forth. GMP exists so that every product made by the pharmaceutical company respects the standards imposed by the appropriate regulatory body and can be assumed to be safe, to produce the desired results and to be effective through the use of standardized methods.
Non-GMP materials are not intended for clinical use and are not subject to the standards imposed by regulatory bodies such as the FDA. Non-GMP items are not meant to be used on humans in clinical trials, so research teams enjoy more flexibility in their use. They can be found in pre-clinical trials or in toxicology studies, but once the product moves to the clinical phases, it will need to conform to the appropriate GMP .