, compounded drugs account for about 1-3% of all U.S. prescriptions. Compounding pharmacies are a vital part of the overall pharmaceutical industry, and they continue to experience modest growth driven by an aging population suffering from chronic diseases requiring personalized dosages or ingredients.
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Traditionally, compounders formulated drugs prescribed by doctors for specific patient needs typical prescription drugs can’t fulfill. For example, a compounding pharmacy may change a drug’s formulation from a pill to a liquid form or exclude an ingredient for a patient with an allergy. Most recently, compounding pharmacies have been tasked with helping alleviate local drug shortages.
According to the American Pharmacists Association, of the 56,000 community-based pharmacies in the US, about 7,500 specialize in compounding services. These pharmacies have made major contributions to patient care by dispensing pharmaceuticals that otherwise may not have been available. Pharmaceutical compounding is essential to the progression of the pharmaceutical industry and personalized medicine.
For some drugs, side effects are commonplace – potentially leading to higher rates of patient non-compliance. Sometimes side effects are more than mere inconveniences – they can be potentially life-threatening adverse events. Compounding pharmacies can increase compliance and mitigate the risk of adverse events by substituting potential allergens with alternative ingredients.
Palatability or another aspect of the delivery method may also cause reductions in compliance. Children, for example, are not keen on taking larger tablets meant for adults. Adults – especially the elderly or those who have trouble swallowing – may also want to avoid large tablets. Compounding pharmacies may offer to cut these tablets or formulate a liquid version of the drug, offering an alternative solution for patients with a specific medical need.
While drug shortages have been on the decline in the U.S., they continue to be a major problem worldwide. Healthcare providers are often limited in their treatment options by the availability of drugs within their regions or communities. Compounding pharmacies are typically equipped with the ingredients and technology to produce drugs that may not be available, resulting in more options for healthcare providers, improving communities’ overall quality of health.
Some patients are underserved by the pharmaceutical community due to cost or lack of access. For example, drugs that must be shipped into a community can cost more than those manufactured locally. Compounding pharmacies are more local and community-affiliated, providing access to patients who may otherwise be excluded from access.
Compounded drugs may offer many benefits, but they aren’t actually FDA-approved, so they do not have some of the same safety and quality assurances as approved drugs. As a result, in the past issues have sometimes emerged with compounded drugs, like the incident in which a Massachusetts-based pharmacy shipped contaminated compounded drug, leading to the death of 60 people.
To avoid such a catastrophe, compounding pharmacies need to look for a few key qualities from their API suppliers.
1. Strict Adherence to cGMP Guidance
In a recent article, the FDA stated that “improper repackaging or lack of supply chain oversight of APIs can cause serious vulnerabilities in the supply chain and may lead to patient safety issues.”
For this reason, compounding pharmacies should look for an API supplier that has a long history of adhering cGMP guidelines, as described by the FDA to ensure the quality of drug products. Among the key requirements: methods, facilities, and controls used to manufacture and package a drug product.
2. Updated FDA Registrations
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the U.S. must register with the FDA. They are also required to list all of their commercially marketed drug products, which the FDA maintains in a catalog of drugs in distribution. Ensure your API supplier is committed to maintaining compliance with all FDA guidelines, including possessing all required registrations.
3. Valid NDC Registrations
In the FDA’s National Drug Code (NDC) Directory, drugs are identified and reported using a unique, three-segment number, called an NDC number. This directory contains information on the active and certified finished and unfinished drugs submitted to the FDA in structured product labeling. The drug company submitting the information is responsible for the accuracy of the listing data, so it’s critical to use an API supplier with valid NDC registrations.
4. Approvals by the Leading Regulatory Authorities
Consumer safety is the top priority within the pharmaceutical industry, which is accomplished partly through regulating authorities. The rules and regulations from these authorities protect people from harm from prescribed drugs. So if the FDA does not regulate compounded pharmaceuticals, who does? It’s complicated. State agencies oversee the pharmacies, the Drug Enforcement Agency oversees the handling of the drugs, and the FDA oversees the integrity of the APIs. This complex, multi-tiered oversight underscores the need to select API providers who are committed to maintaining approvals and navigating all leading regulatory authorities.
5. Fully-Compliant API Quality
Active Pharmaceutical Ingredients (APIs) are the most important components of manufactured drugs – and quality compliance is non-negotiable, especially for compounding pharmacies because of the complex nature of the work. For this reason, compounding pharmacies must work with an API supplier that tests and sources the best quality materials and meets all applicable guidelines.
You may have noticed that compliance and quality are the underlying themes of selecting an API supplier for pharmaceutical compounding. Regulations around the pharmaceutical industry are in place to protect patients, so it’s critical to find an API supplier that is highly diligent with all compliance and regulatory requirements. One popular path when navigating API suppliers for compounding pharmacies is to work with a sourcing partner who maintains quality assessments of their various API suppliers and can find the right match based on your specific criteria.
Contract developers and manufacturers of active pharmaceutical ingredients (APIs) are now playing an even more fundamental role in contemporary drug development strategies.
A report by analyst firm visiongain forecasts that the overallpharmaceutical contract manufacturing market is growing fast, achieving revenues of $84.0 billion by at a compound annual growth rate of 6.4% from . The market, says visiongain analysts, is expected to continue to grow from to as more pharmaceutical companies strategically outsource manufacturing services.*
With the growing reliance on contract services and a fragmented landscape creating plenty of choice, it is more critical than ever to pick the right CDMO.
Where API strategy and procurement tactics intersect
Because most product plans are unique, choosing a small molecule API and drug substance manufacturer that can provide excellent quality, while routinely demonstrating supply reliability over a drug’s entire lifecycle, is worth a concerted effort. Finding a “perfect” partner to marry your drug strategy can be as challenging as it is critical to market success.
Critical qualities and attributes of strategic small molecule API partners
Pharma’s drug developers are increasingly sourcing APIs from CDMOs. These intellectual property owners have to evaluate a number of critical aspects in making their choice for such a strategic partnership, including the overall program’s financial viability. More and more current drug strategies hinge on the partner’s technical and operational capabilities and their experience synthesising the target compound in question. Most procurement professionals understand these competing priorities despite extreme pressure from their organizations to closely control program costs.
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That’s why when selecting a partner to develop and manufacture small molecule APIs and meet strategic business interests, the decision to choose a supplier must be weighted appropriately among all the critical, strategic attributes a “perfect” API partner should have.
Here are six critical, strategic attributes to consider right up front when choosing a small molecule API partner:
1. Reliable supply chain
Great access to a well-executed quality supply chain is an essential attribute of any strategically important supplier. How well one’s API supplier manages its own raw material supply chain is a leading indicator. Any disruptions to your supplier’s supply chain and your API delivery may be delayed. Pfizer CentreOne, being embedded within Pfizer has direct access to one of the industry’s most developed, secure and reliable supply chains in the industry
2. Robust, relevant process expertise and experience
Drug development routes are getting more complicated and the APIs in high therapeutic demand are getting harder to make. Robust process development is paramount, but it has to be matched to deep science and process engineering acumen. This clearly extends to troubleshooting and refining synthesis to find new or better production and cost economies, as well as creating those more robust and effective processes that increase quality and reliability.
3. Knowledgeable in how to accelerate your product’s pace to market
Pharma understands that the more directly and succinctly a drug developer can manage a drug’s critical timelines on the way to market, the more successful the product will be financially, both in the near and far term.
Early, intensive synthesis analysis is one good way potential partners can add value. Pfizer CentreOne for example, was presented recently with a synthesis that was unsafe to reproduce even under the strictest of lab conditions and controls.
Within a very intensive timeframe, Pfizer chemists and process engineers were able to define a much more stable, scale-able chemistry to reliably make the high-value therapeutics being developed by the company
4. Great quality systems, operational excellence and the staff to back it up
Achieving critical quality attributes (CQAs) with consistency and transparency is certainly a prerequisite for any strategic supply relationship. But for pharma, it’s a fundamental requirement and a key performance indicator when assessing the potential for long-term reliability and quality when choosing a strategic API supplier.
For APIs of every kind, one common CQA denominator is the ability of your API developer and manufacturer to effectively, cost efficiently control contaminants or impurities during all primary and intermediary processing steps.
Another KPI is controlling and manipulating an API’s physical properties effectively is another KPI. A CDMO partner with the staff, technology and experience to evaluate and address your API’s physical properties for therapeutic action and other goals is intrinsically strategic. A supplier that can accurately engineer drug substance attributes to meet drug formulation and drug product (DP) targets early in a small molecule API program can often yield efficiencies to leverage later in the journey to market.
Lastly, when combined with a robust and repeatable process, “small molecule” API becomes “commercial-ready” API with a validated process well-proven and ready to go the distance over the drug product’s intended life-cycle.
5. An extremely conscious approach to sustainable industrial process
Thinking environmentally? Suppliers that can provide more stable, less volatile chemistries and efficient batching are more efficient. Those with experience optimizing processing methods that reduce or recycle intermediates and other hazardous by-products, are worth considering very carefully.
CDMOs that put an emphasis on delivering cleaner chemistries that reduce their impact on the environment through best-practice operations and technical mastery are better able to deliver project economies. With literally hundreds of CDMO partners to choose from, those that live core sustainability principles of re-use, recycle and reduce, are likely to be both great environmental stewards and the most cost-efficient processors.
6. A singular focus on continuous improvement, flexibility and intelligent collaboration
Processing API batch after batch, month after month, year-after-year may, over time, introduces complacencies and issues related to status-quo in process, operations and technology. If your chosen small molecule API manufacturer is not continuously focused on continuous process improvement, they may not be the perfect partner for strategic drug supply.
CDMOs with experience and vision will likely be able to bring an intelligent, collaborative approach to partnering and the insight needed to innovate solutions. Part of this comes from the talent and resourcefulness of the people who make your API and how they leverage the resources and technologies to assure the best outcomes of every batch. These attributes support creating an environment that is responsive, agile and more capable of performing over the long run.
Whatever your product’s market agenda might be, drug owner and drug maker often have to build a common base of knowledge and do it in a timely and prescribed manner. Better drugs begin with a better, smarter collaboration and the sooner both parties can achieve a true and transparent meeting of the minds, the better.
A strategic API partner will always be seeking ways to innovate and improve your compound or product’s value as part of the deal, and do it with the dedication of a partner, not a supplier.
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