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Suppliers and packagers for generic pharmaceutical drug: DUVELISIB
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DUVELISIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-28 | 28 CAPSULE in 1 PACKAGE (73116-215-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-56 | 56 CAPSULE in 1 PACKAGE (73116-215-56) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-28 | 28 CAPSULE in 1 PACKAGE (73116-225-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-56 | 56 CAPSULE in 1 PACKAGE (73116-225-56) | 2018-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Duvelisib: A Comprehensive Analysis of Global Suppliers and Supply Chain Dynamics
Duvelisib, marketed under the brand name Copiktra, is a dual phosphoinositide 3-kinase (PI3K) delta and gamma inhibitor approved for treating relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). Its development, commercialization, and supply chain involve a network of manufacturers, suppliers, and distributors across multiple regions. This report examines the key players in the Duvelisib supply chain, regulatory considerations, and market dynamics shaping its global availability.
Active Pharmaceutical Ingredient (API) Manufacturers
Epoch Labs and Indian Manufacturing Landscape
Epoch Labs, based in Hyderabad, India, is a prominent Duvelisib API manufacturer listed on PharmaCompass[1][6]. The company specializes in research and development services for pharmaceutical and agrochemical industries, adhering to Good Manufacturing Practices (GMP) to meet international regulatory standards. Epoch Labs’ role in the Duvelisib supply chain highlights India’s growing prominence as a hub for cost-effective API production. PharmaCompass data indicates that Epoch Labs provides Duvelisib API with certifications such as US Drug Master File (USDMF) and Certificate of Suitability (CEP), ensuring compliance with U.S. and European regulatory requirements[1][11].
Curia Global and U.S.-Based Production
Curia Global, Inc., formerly known as AMRI, is another critical player in Duvelisib manufacturing. The company handles API analysis and production for Copiktra, as documented in the DailyMed label[7]. Curia’s involvement underscores the stringent quality control processes required for oncology therapies, particularly those with orphan drug designations. The FDA’s approval of Duvelisib in 2018 necessitated rigorous adherence to current GMP (cGMP) standards, which Curia fulfills through its advanced analytical and manufacturing facilities[5][7].
Regional Suppliers and Strategic Partnerships
CSPC Pharmaceutical Group in China
In 2018, Verastem Oncology entered an exclusive licensing agreement with CSPC Pharmaceutical Group to develop and commercialize Duvelisib in China[8]. CSPC, a constituent of the Hang Seng Index, leverages its extensive distribution network and experience in oncology products like doxorubicin liposome to advance Duvelisib’s market penetration. This partnership reflects the strategic importance of regional licensing to address localized regulatory and logistical challenges, particularly in a market as complex as China[8][14].
AbbVie’s Role in Ex-U.S. Markets
AbbVie’s collaboration with Infinity Pharmaceuticals (later Verastem Oncology) in 2014 aimed to accelerate Duvelisib’s global development[16]. While AbbVie’s direct manufacturing role remains unclear, the partnership highlights the role of multinational pharmaceutical companies in facilitating clinical trials and regulatory submissions outside the U.S. AbbVie’s infrastructure likely supported early-stage production and distribution in regions such as Europe and Japan[4][16].
Formulation and Finished Product Suppliers
Secura Bio’s Acquisition and Commercialization
In 2020, Secura Bio acquired global rights to Copiktra from Verastem Oncology for $70 million upfront, with potential payments exceeding $310 million based on milestones[14][15]. As the current marketer, Secura Bio oversees finished product formulation, including the encapsulation of Duvelisib into 15 mg and 25 mg gelatin capsules[5][7]. The company’s manufacturing partners, such as Curia Global, ensure that drug products meet specifications for dissolution, stability, and bioavailability[7].
Daicel Pharma’s Role in Quality Control
Daicel Pharma contributes to the supply chain by producing Duvelisib impurities and reference standards, critical for quality assurance during API synthesis[9]. Their offerings include custom-synthesized degradation products analyzed via NMR, IR, and HPLC, ensuring compliance with International Council for Harmonisation (ICH) guidelines. Daicel’s work exemplifies the specialized niche suppliers that support primary manufacturers in maintaining regulatory compliance[9].
Distribution Networks and Specialty Pharmacies
Biologics, Inc. and McKesson’s Distribution Channels
Biologics, Inc., a subsidiary of McKesson, operates as a specialty pharmacy distributor for Copiktra in the U.S.[12]. Its inclusion in Verastem’s limited distribution network ensures controlled access to Duvelisib, minimizing diversion and optimizing patient support programs. Specialty pharmacies like Biologics play a pivotal role in bridging manufacturers, healthcare providers, and patients, particularly for therapies requiring rigorous adherence monitoring[12].
Regulatory Compliance and GMP Requirements
FDA Oversight and cGMP Standards
The FDA’s approval of Duvelisib mandated compliance with cGMP standards, which govern every aspect of production, from raw material sourcing to final packaging[5][7]. API manufacturers must submit detailed Drug Master Files (DMFs), while finished product suppliers like Secura Bio undergo periodic facility inspections. The FDA’s 2020 safety alert, prompted by increased mortality risks in the DUO trial, further underscores the need for robust pharmacovigilance systems across the supply chain[2][7].
International Certifications and Market Access
Suppliers targeting global markets must obtain certifications such as European Write-Up (EU-WC) and Japan Drug Master File (JDMF)[1][11]. For instance, Epoch Labs’ CEP certification enables Duvelisib API exports to the EU, while CSPC’s adherence to Chinese GMP facilitates local production[8][11]. These certifications are critical for navigating fragmented regulatory landscapes and ensuring uninterrupted supply.
Market Dynamics and Pricing Considerations
Factors Influencing API Pricing
PharmaCompass data reveals that Duvelisib API pricing fluctuates based on production costs, regulatory changes, and negotiated contracts[1][11]. For example, the transfer of commercial rights from Verastem to Secura Bio in 2020 likely introduced new pricing agreements with contract manufacturers. Additionally, orphan drug exclusivity in the U.S. and EU grants temporary market monopolies, allowing suppliers to maintain premium pricing until generic entry[4][14].
Competition from Generic Manufacturers
While no generic versions of Duvelisib are currently marketed, India’s Epoch Labs and other API producers are well-positioned to enter the market post-patent expiry. The anticipated 2025 Phase III trial for peripheral T-cell lymphoma (PTCL) could extend Duvelisib’s exclusivity, but long-term supply chain stability will depend on diversifying manufacturing sources and reducing dependency on single suppliers[4][14].
Future Directions and Clinical Expansion
Secura Bio’s Pipeline and Global Trials
Secura Bio is advancing Duvelisib into Phase III trials for PTCL (TERZO trial) in the EU and U.S., with patient enrollment expected in 2025[4]. Successful outcomes could expand the drug’s indications, necessitating scaled-up production and additional partnerships. The company’s collaboration with Yakult Honsha in Japan further illustrates the strategic use of regional expertise to address specific market needs[4][16].
Sustainability and Green Chemistry Initiatives
API manufacturers like Divi’s Laboratories (though not directly linked to Duvelisib) emphasize green chemistry principles and backward integration to reduce environmental impact[10]. Applying similar practices to Duvelisib production could lower costs and align with global sustainability trends, enhancing supplier competitiveness.
Conclusion
The Duvelisib supply chain is a multifaceted network involving API manufacturers, formulation experts, regional licensors, and specialty distributors. Companies like Epoch Labs, Curia Global, and CSPC Pharmaceutical exemplify the collaborative effort required to bring oncology therapies to market. As Secura Bio advances clinical trials and navigates regulatory landscapes, the interplay between innovation, compliance, and market strategy will remain critical to ensuring global access to Duvelisib.
"The future of oncology supply chains lies in strategic partnerships and agile manufacturing models that prioritize patient safety and regulatory excellence." — PharmaCompass Industry Report[1]
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/duvelisib
- https://en.wikipedia.org/wiki/Duvelisib
- https://pmc.ncbi.nlm.nih.gov/articles/PMC6631818/
- https://adisinsight.springer.com/drugs/800035173
- https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211155Orig1Orig2s000ChemR.pdf
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ipi-145-ink-1197-duvelisib
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c5ac56-e1f6-473a-bc73-687836534780
- https://www.biospace.com/cspc-pharmaceutical-group-limited-and-verastem-oncology-sign-exclusive-license-agreement-for-the-development-and-commercialization-of-copiktra-duvelisib-in-china
- https://www.daicelpharmastandards.com/product-category/duvelisib
- https://www.divislabs.com/api-manufacturer-world/active-pharmaceutical-ingredients/
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/duvelisib-inn
- https://www.mckesson.com/about-mckesson/newsroom/press-releases/2018/copiktra-available-for-order-at-biologics/
- https://meekapharmacare.com/pharma-api/
- https://www.biospace.com/secura-bio-signs-agreement-to-acquire-global-rights-to-oncology-drug-copiktra
- https://www.paulhastings.com/news/news-secura-bio-to-acquire-global-rights-to-oncology-drug-copiktra
- https://news.abbvie.com/2014-09-03-Infinity-And-AbbVie-Announce-Global-Strategic-Collaboration-To-Develop-And-Commercialize-Duvelisib-IPI-145-In-Oncology
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