Drug manufacturers and their suppliers face a number of challenges, such as downward pricing pressures and the need for flexibility and speed to market. To be successful, suppliers must differentiate themselves from their competitors by presenting capabilities that can simplify and strengthen the supply chain while demonstrating added value.
A Strategic Element
A robust supply chain is one strategic element that drug companies need to help them stay ahead of the competition. A strong supply chain should include highly dependable and knowledgeable primary suppliers who can impart reliable technical know-how, skills and service to their drug company partners. To achieve this, a company must rely on an extensive network of contract organizations that will positively impact the technology and bottom line of the drug manufacturer by providing counsel throughout, in addition to quality product at the best price.
Considerations in Capsule Supply
One of the most fundamental partnerships for many pharmaceutical companies is their capsule supplier. Gelatin capsules are widely used and are often the preferred dosage form for generic and OTC drugs. These capsules can be filled solid dosage pharmaceuticals, as well as semi-solid and liquid dosage forms, to offer the advantages of low oxygen permeability and constant dimensions.
The empty capsules market has seen considerable growth in recent years, and a recent market report by research firm Precision Business Insights predicts considerable growth in this segment over the next 5 years and beyond.1 This upward expansion is being driven by a confluence of factors, including an increase in technological advancements offering advantages such as taste and odor masking, increased bioavailability and stability of drug products, and enteric coating and extended release. There has also been a rise in consumer demand for capsules over tablets, which has been partially fueled by new opportunities for attractive and distinctive capsule design.
As a variety of capsules are on the market, including both traditional gelatin capsules and, increasingly, vegetarian, plant polysaccharide–based options — including hydroxypropyl methylcellulose (HPMC) capsules, a drug manufacturer needs a dependable supplier that can ensure sourcing and who possesses reliable backup production capabilities.
Key Considerations
Among the key concerns that pharmaceutical manufacturers have about their suppliers, including capsule suppliers, is whether they have sufficient capacity to supply a continuous quantity of product. For this reason, contingency planning is essential. Typically, a pharma company will not only engage a primary capsule supplier but also a secondary supplier to ensure that they establish a strong supply chain capable of adaptation to any issues that could arise from the primary supplier to prevent production delays. A 2016 change in the U.S. Food and Drug Administration’s (FDA) policy on hard capsule supply — allowing manufacturers to change suppliers via an annual report to the FDA rather than a prior approval supplement, provided that the capsules are consistent in composition and appearance — has made it easier for companies to change suppliers, particularly for secondary sourcing.
While this regulatory change has provided companies with more flexibility in exploring new capsule suppliers, the primary driver thus far appears to be cost savings. Pharma companies may not be fully considering tactical ways to strengthen the supply chain when engaging with suppliers, such as location, capabilities, the advantages of vertical integration of raw materials and finished empty capsule supply or value-added services. A strategic partnership with a capsule supplier that possesses internal dual-sourcing capacity provides a single relationship capable of both primary and back-up supply, obviating the need to engage a secondary supply source.
Another paramount consideration when evaluating suppliers is regulatory experience and expertise, which can help the pharmaceutical company navigate the regulatory waters. Typical concerns include whether the supplier is registered with the FDA, whether its master files are in order, whether certifications are up to date, and whether the supplier’s raw materials are suitable for use in different geographic areas, such as the European Union.
Demonstrating Added Value
A strategic partnership with a capsule supplier like CapsCanada confers many additional benefits for those looking to secure a dependable and robust supply chain. For companies based in North America, CapsCanada offers local manufacturing supported by warehouses throughout the continent, enabling quick turnarounds and same/next-day delivery without the wait times associated with shipping products overseas or the complications of ocean or air freight containers. A regionally based facility also guarantees lead times that cannot be matched by other suppliers. At CapsCanada, we commit several dedicated production lines of capacity for larger customers — which they can inspect at any time — and even stock product for them so that they do not have to carry large inventories. As a full development partner, CapsCanada can assist customers from early in their development cycle through contingency planning and supply chain logistics.
Pharmaceutical manufacturers are looking for primary suppliers who can offer such value-added services as formulation assistance, regulatory compliance guidance and technical service. CapsCanada differentiates itself with its strong formulation expertise, regulatory knowledge and technical service capabilities as well as extensive R&D and stability testing on its empty capsules. Its global technical service team has an extensive knowledge of filling machines, and can help customers address equipment issues at no extra charge.
CapsCanada offers a suite of capsule options, including gelatin capsules for solid and liquid dose formulations, HPMC vegetarian capsules, acid-resistant capsules for enteric dissolution, and capsules designed to avoid formulation issues during clinical trials and reduce time to market. Additionally, we offer a range of customizable capsule options, including capsule colors, logo and text printing and banding that elevate the capsule from a dosage form to an essential part of a drug’s branding and differentiation. Such high-level, unique capabilities provide true value for customers.
Integrated Gelatin Supply
For drug manufacturers, having a dependable supplier is vital to the organization overall. Unlike other manufacturers, CapsCanada addresses dependability concerns by owning its entire gelatin capsule supply chain, starting with our internal raw material supplier. This unique vertical integration model guarantees the quality of our gelatin and enables us to provide long-term, continuous supply chain support, from sourcing to distribution.
Dual Sourcing
CapsCanada possesses internal dual-sourcing capacity, with state-of-the-art facilities in both Windsor, Ontario, Canada and Barranquilla, Colombia. Gelatin capsules produced in the two facilities reflect the same raw material supply, composition, and dyes, and adhere to cGMP conditions and standards. If any issues were to arise with production of capsules for a customer at either facility, CapsCanada is able to switch production to the other facility, maintaining an identical product without disruption of the supply chain or extended lead times.
Fast to Market
It is also significant for a supplier to be able to custom manufacture a product and get it to market quickly. CapsCanada provides comprehensive support from preclinical trials to bioequivalence testing and regulatory submission. Developed specifically for innovative or generic drugs, the company’s Fast-to-Market package streamlines the regulatory process and accelerates time to market by up to 9 months.
By partnering with CapsCanada, drug manufacturers receive the benefit of the company’s resources as they prepare the necessary documentation for their NDA/ANDA or international equivalent and the support of CapsCanada’s regulatory compliance experts through the submission process.
Strong Commitment to Customers
We feel we are the most reliable primary supplier and full development partner for capsule manufacturing. With a complete understanding of all possible manufacturing and supply chain issues and needs, we are able to provide practical, integrated solutions to our customers from start to finish.
References
- Empty Capsules Market: Global Market Estimation, Dynamics, Regional Share, Trends, Competitor Analysis 2012 to 2016 and Forecast 2017 to 2023. Rep. Precision Business Insights. 30 Mar. 2018. Web.