In the realm of pharmaceuticals, drug manufacturing includes many intricate procedures. The quintessential part of this practice is the drug’s biologically active element, also known as Active Pharmaceutical Ingredient (API). It is present in drug products like tablets, capsules, injection vials, creams etc. This component determines the possibility of attaining the desired effect from a drug in the vivid specialities of medicine. API also helps in identifying & differentiating between the generic version & the branded names of the same medicine.

Though this component holds such a crucial part in the pharma production methodology, the ingredient is present in a smaller ratio of the medicinal composition. Many pharmaceutical manufacturers do not produce APIs, thus they are dependent on pharma contract companies that take up the API contract manufacturing. Also known as Contract Development & Manufacturing Organisation (CDMO), possess the infrastructure, skills and regulatory approvals necessary for API contract manufacturing. These manufacturers need to comply with stringent norms and regulations as it is necessary for matching the qualitative aspects and avoiding contamination.

Several active pharmaceutical ingredients contract manufacturing companies are responsible for the testing, production & retailing the high-potency APIs & API intermediates. With adept equipment showcasing meticulous manufacturing capacity, the pharma contract companies scale up the production as per the client’s requirement and ensure an uninterrupted supply chain.

Benefits of API Contract Manufacturing

• Inexpensively Produced: With the outsourced nature of the job, API contract manufacturing is an affordable alternative for several pharmaceutical companies that want to cut down on the cost of researching & developing specific medicinal components. The operational cost is less whereas the substantial investment for acquiring the infrastructure & expertise can be avoided. With the help of these CDMOs the expenses of setting up and maintaining the research & analysis facilities lapses.

• Scalable Efficiency: The pharma contract companies assigned with the task of developing the API can easily increase or decrease the voluminous production based on the market demands. Therefore showcasing an enhanced flexible nature of the production capability further optimising the resource utilisation & manufacturing cost.

• Convenient Access to Expertise & Technologies:  With a specialised approach many CDMOs initiate API contract manufacturing after employing the latest technology & highly skilled professionals. The pharma companies conveniently leverage the expertise & technology to accelerate the production and commercialisation of a specific product.

• Enhancing Core Competencies: Delegating the API contract manufacturing promotes the other necessary procedures of the pharma companies which predominantly are the research, analysis, development & retailership procedures. Other than the aforementioned competencies there are other factors that the pharmaceutical company is relieved from such as risk mitigation, rapid market entry & compliance. Active pharmaceutical ingredient contract manufacturing includes certain regulatory risks that are to be managed by the CDMOs, providing peace of mind to the pharma companies.

• Regulatory Compliance: With a flexibly fast-paced nature, the pharma contract manufacturers can help pharma companies get their products faster to the market. The pharma contract manufacturers efficiently navigate the regulatory prospects, thus complying with all relevant regulations such as Good Manufacturing Practices (GMP).

Challenges & Considerations of API Contract Manufacturing

Along with the benefits, API contract manufacturing has its own set of obstacles that have to be overcome by the pharma companies. These challenges can be listed down as follows:

• Qualitative Competency: Pharmaceutical companies always need to be mindful about collaborating with any CDMO for API contract manufacturing as it resonates in the manufactured API’s quality. The pharma entities need to fulfil the due diligence with the CDMOs to further check their track records which can be in an organised manner such as its production capacity, level of expertise, arsenal of equipment & regulations they comply with. These aspects will help understand the quality & reliability of APIs produced under a specific CDMO’s surveillance.

• Safeguarding Confidentiality: Many CDMOs do have certain criteria in place to protect the patented information regarding the API, though it’s not always the case that this is a mandatory practice in several other pharma contract manufacturers. Such instances are what encourage several pharma companies to implement safeguarding measures to protect their proprietary information.

• Accidental Contamination: As mentioned earlier, there is a high possibility of a spike in the amount of impurities that breach into the produced set of APIs, especially during the time of upscaled setup of manufacturing. Therefore, leading to unexpected results, such as new impurities that were unforeseen during the scaled-down version of the production setup. This is eliminated with the help of the R&D team at the pharma contract manufacturer’s end who will analyse the whole lot of APIs produced.

• Production Duration & Temperature Calibration: As the API contract manufacturing fluctuates based on the demand & supply criteria the major focus turns to the stability of the material produced in the time constraint without any fault in the process of production. Though with supreme expertise and advanced equipment, in case the CDMO’s professionals imply the wrong temperature, be it too low or too high it can adversely impact the product quality.

• Supply Chain Risks: Dependency on external suppliers and vendors for the active pharmaceutical ingredients contract manufacturing exposes pharma companies to supply chain risks such as geopolitical disruption, raw material shortage & product grade inconsistencies. This can be solved with the adoption of robust supply chain management strategies & contingency plans by the pharma entities for continued production capability & risk mitigation.

As API’s priority is to be the most effective component of any composition providing the necessary results from a minimal quantity, thus any sort of shortcoming can be detrimental to the patient’s health, so the API’s efficacy and quality need to be maintained.

In conclusion, API contract manufacturing is an important aspect of the pharmaceutical industry by enabling companies to access specialised expertise, streamline operations and bring innovative products to market efficiently. The range of services provided by any pharma contract manufacturer is tailored to the specific needs of the clients, such as Neunco. The expanse of expertise, the infrastructure & the skillset is unmatched to deliver the results promptly. Connect with the professionals at Neunco to learn more about API contract manufacturing & how it’s done proficiently.