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The Active Pharmaceutical Ingredient (API) is the organ by which active pharmaceutical ingredients are produced from raw materials both through physical and chemical means. Based on the intricacy of the molecule required, API synthesis might require complex chemistry that utilizes a range of processing technology.
Pharmaceutical companies are growingly enlisting the aid of API manufacturers to enhance efficiencies. API manufacturing has always been a competitive market. However, as pharmaceutical giants outsource their manufacturing, this is set to intensify. Each and every step taken by pharmaceutical organizations to produce medications is extremely important, and one among them that is noteworthy is the inclusion of active pharmaceutical ingredients. The big players usually depend on suppliers for the ingredients and its intermediaries.
Since APIs are the most important component of a medication, pharmaceutical companies should always be on their toes while choosing the right API sourcing firm.
Know the background
As a rule of the thumb, a prerequisite to get high quality products is to conduct a thorough background check of your supplier. The right strategies for innovation in pharmaceutical sourcing and procurement is of paramount importance to get guaranteed quality products. An exhaustive research of the API supplier will assist you in determining the many facts about his market standing, financial strengths and business practices, licensing, existing clients, client base and many more.
Knowing your potential supplier’s clientele-who the supplier caters to-can reveal a lot about his business. For instance, a supplier who caters to top brands is undoubtedly a reputable supplier. It’s also important to get reviews from the supplier’s past and present clients as your business’s reputation rides on it. While discussing about future business opportunities, companies should ask them for references for their reputation.
While checking a supplier’s background, it’s equally important to know about their annual turnover and manufacturing capacity. This information can help you get an idea of the level of progress they have achieved in the field of API.
Another important factor while choosing an API supplier is quality. When contacting API suppliers, it’s important to ensure that they supply high quality substances. Furthermore, regulatory compliance, documentation, storage of APIs as well as labeling, packaging, production and release should meet the standards as laid down by the FDA. Client confidentiality is important and companies should ensure that suppliers maintain absolute confidentiality while dealing with their clients. A reputable supplier needs to have a suitable system in place to approve or dismiss raw materials, intermediate materials, labeling or packaging materials based on their discretion. All manufacturing records have to be evaluated thoroughly by the supplier to ensure that all the essential steps are rightly followed. Pharmaceutical companies should ascertain that the supplier releases the API to the market only after all the criteria have been met.
Guarantee and Responsibility
A credible API supplier should be prepared to vouch for the ingredients they supply and take responsibility for the quality of the product. They should also agree to the terms and conditions related to the quality of the ingredients supplied and take responsibility if an ingredient fails to make it through the quality test as it’s a matter of life and death.
Cost Effective and Efficient
Finances are one of the most important factors while choosing a supplier, especially, if you are on the lookout for a long haul business connection. However, costs should not only be the main criteria. A perfect supplier should be able to offer a full range of services from customer service and sales to international logistics and domestic warehousing. The supplier also has to be able to bring APIs to you anywhere in the world, and ensure that you get the product in a given time frame. In other words, a reputable API supplier has to be both cost-effective and efficient. This is the main reason why top contract API manufacturers like Almac are able to work with hundreds of clients and aim to touch 100% capacity utilization in manufacturing while keeping their costs as low as possible. It’s best to get quotes from a couple of suppliers and pick the one that best fits you.
While talking to your supplier, you should consider different expenses like sales, excise, custom along with different insurance costs and duties since all of these will add to your manufacturing cost. So consider all these aspects while choosing a supplier.
One of the major trends in API manufacturing over the years has been the inexorable shift in production from the historical leaders in Western nations to newer countries in China and India. This trend will continue as the API industries in China and India are growing at approximately 17.6% and 19.3% per year respectively, according to Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines. While Italy still rules the roost in API sectors like central nervous system and cardiovascular, China heads in anti-infective APIs, with nearly 43% of global market share.
Lower production costs in China and India drive much of this growth. For instance, the total cost of developing, manufacturing, testing, and marketing a generic drug in India costs just 20% to 40% of the expenses in the West.
Since API and Intermediates play a fundamental role in modern drug development, the procurement pharmaceutical company should be absolutely convinced before selecting a supplier. The points mentioned above will help you procure API and Pharma Intermediates.