Share This Page
Suppliers and packagers for generic pharmaceutical drug: acalabrutinib maleate
✉ Email this page to a colleague
acalabrutinib maleate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387 | NDA | AstraZeneca Pharmaceuticals LP | 0310-3512-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60) | 2022-08-04 |
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387 | NDA | AstraZeneca Pharmaceuticals LP | 0310-3512-95 | 60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95) | 2022-08-04 |
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4513-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60) | 2022-08-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ACALABRUTINIB MALEATE
Introduction
Acalabrutinib Maleate, marketed under brand names such as Calquence by AstraZeneca, is a targeted therapy used primarily for the treatment of specific B-cell malignancies, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). As a potent Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib has gained significant attention within oncology therapeutics, prompting interest from manufacturers, suppliers, and healthcare providers globally. This report offers an in-depth analysis of the key suppliers for acalabrutinib maleate, examining manufacturing sources, supply chain dynamics, and market considerations crucial for stakeholders involved in procurement, investment, or regulatory oversight.
Manufacturers of Acalabrutinib Maleate
1. AstraZeneca
Marketed Formulations and Licensing
AstraZeneca holds the original patent and marketing rights for acalabrutinib under the trade name Calquence. The company developed the molecule following extensive research and clinical development, securing FDA approval for specific indications in 2017 and subsequent approvals worldwide.
Manufacturing Scope
AstraZeneca’s manufacturing facilities for acalabrutinib are located across North America, Europe, and Asia, with production primarily focused on active pharmaceutical ingredient (API) synthesis and finished dosage forms (FDF). The company maintains strict quality controls and regulatory compliance standards, and as a globally recognized pharmaceutical entity, AstraZeneca is the primary source of manufacturing for commercial supply.
Manufacturers and Contract Development & Manufacturing Organizations (CDMOs)
AstraZeneca collaborates with multiple CDMOs to meet increasing demand. These relationships include contract manufacturers for both API and formulations, such as Lonza, Avara Pharmaceutical Services, and others aligned to global regulatory standards.
2. Contract Manufacturers and API Suppliers
Active Pharmaceutical Ingredient (API) Production
The API for acalabrutinib is complex, involving multiple synthesis steps. Key API manufacturing entities include:
- Lonza Group: A Swiss-based contract manufacturing organization known for APIs in oncology and immunology. Lonza supplies acalabrutinib API under contractual agreements with AstraZeneca or other licensees.
- Avara Pharmaceutical Services: A US-based CDMO specializing in oncology API production, providing manufacturing capacity for acalabrutinib or its intermediates.
- Other Generators: Several regional API producers in Asia (China, India, South Korea) have developed or are in licensing negotiations with innovator companies for the synthesis of acalabrutinib, driven by local regulatory pathways and cost advantages.
Source Verification and Regulatory Compliance
Many API suppliers operate under Good Manufacturing Practices (GMP) certifications aligned with FDA, EMA, and other regulatory agencies, ensuring product quality and consistency. Due to the high complexity and stringent quality requirements, the number of qualified API suppliers remains limited to a select group of large, certified organizations.
Distribution and Supply Chain Dynamics
Global Supply Chain Considerations
The supply chain for acalabrutinib maleate involves multiple stages: raw material procurement, API manufacturing, formulation, packaging, and distribution. Disruptions at any point—such as raw material shortages, geopolitical issues, or regulatory delays—can impact supply availability.
Geographical Diversification
Manufacturers often diversify their supply chain geographically to mitigate risks. For example, AstraZeneca and API suppliers source raw materials globally, predominantly from Asia and Europe. Such diversification supports steady supply and flexibility in meeting global demand.
Regulatory and Patent Landscape
The patent expiration timeline and regulatory approvals influence the number of generic manufacturers authorized to produce acalabrutinib maleate. As patent expiry approaches, licensed generic companies in India and China are expected to enter the market, increasing supplier options.
Emerging Suppliers and Market Entry Barriers
Generic Manufacturers
Once patent protections lapse, entry barriers lower significantly, encouraging licensees and generic pharmaceutical companies to produce acalabrutinib maleate. Companies such as:
- Dr. Reddy’s Laboratories (India)
- Sun Pharmaceutical Industries (India)
- Hetero Labs (India)
- Celltrion (South Korea)
are anticipated or confirmed to develop biosimilar or generic versions, including procurement of API from established suppliers.
Licensing and Technology Transfers
Many small and mid-sized companies acquire rights through licensing agreements to manufacture acalabrutinib API or formulations, navigating complex regulatory, technological, and quality assurance standards.
Role of Regulatory Agencies and Quality Standards
Suppliers to acalabrutinib maleate must adhere to strict GMP guidelines established by agencies like the FDA, EMA, and PMDA. Certificates of suitability (CEP), Drug Master Files (DMFs), and other documentation are crucial for global acceptance.
Regulatory agencies often conduct inspections of manufacturing facilities, and non-compliance can lead to delays or disqualification from the supply chain. Suppliers with established GMP certifications and proven compliance are considered more reliable.
Pricing and Market Competition
The presence of multiple suppliers post-patent expiry can lead to price reductions, increasing accessibility. Currently, AstraZeneca’s pricing and supply considerations influence market penetration across regions. The entry of generic manufacturers would likely alter global supply landscape, improve affordability, and expand access, especially in emerging markets.
Key Supply Chain Challenges
- Raw Material Scarcity: Key intermediates and raw materials are limited and often sourced from specific geographic zones.
- Manufacturing Complexity: The synthesis of acalabrutinib involves complex chemistries, heightening manufacturing risks.
- Regulatory Approvals: New suppliers or generic entrants require extensive regulatory approval, prolonging time-to-market.
- Intellectual Property: Patent protections may restrict generic production until expiration or licensing.
Conclusion
The supply landscape for acalabrutinib maleate centers predominantly around AstraZeneca, which leverages global CDMOs and API manufacturers such as Lonza, Avara, and regional Asian suppliers. As patent protections expire, the market is expected to witness increased participation by generic producers, diversifying supply sources and reducing costs. Ensuring supply chain robustness demands ongoing evaluation of manufacturing compliance, raw material sourcing, and regulatory landscapes.
Key Takeaways
- Primary Supplier & Manufacturer: AstraZeneca dominates the current supply, utilizing a network of global contract manufacturing organizations for API and formulation.
- API Manufacturing: Limited qualified suppliers, notably Lonza and Avara, ensure high-quality production under GMP standards.
- Market Dynamics: Patent expiry will significantly expand the number of suppliers, increasing competition and lowering prices.
- Supply Chain Risks: Raw material availability, geopolitical factors, and regulatory hurdles remain critical points for supply stability.
- Strategic Considerations: Stakeholders should monitor licensing agreements, regulatory developments, and the entry of generic manufacturers to adapt procurement strategies effectively.
FAQs
1. Who are the main current suppliers of acalabrutinib maleate?
AstraZeneca is the principal supplier, collaborating with contract manufacturers like Lonza and Avara for API production. These entities operate under strict GMP regulations to ensure product quality.
2. Are generic versions of acalabrutinib available?
As of now, generic versions depend on patent expiry. Once patents expire, licensed generic manufacturers from India, China, and other regions are expected to produce acalabrutinib maleate, increasing supply options.
3. What challenges do suppliers face in manufacturing acalabrutinib?
Complex synthesis routes, raw material sourcing, regulatory compliance, and quality assurance are key challenges. Manufacturing requires specialized facilities and stringent oversight.
4. How can supply chain risks for acalabrutinib be mitigated?
Diversifying manufacturing partners, establishing multiple regional sources, and maintaining high regulatory standards are essential strategies; also, monitoring geopolitical and raw material supply risks.
5. What factors influence the pricing of acalabrutinib worldwide?
Patent status, manufacturing costs, competition level, regulatory requirements, and regional pricing regulations significantly impact acalabrutinib’s market pricing.
References
[1] AstraZeneca. Calquence (Acalabrutinib) [Product Information].
[2] U.S. Food & Drug Administration. FDA approves Calquence for CLL.
[3] Pfizer, Lonza collaboration details.
[4] Market analysis reports on BTK inhibitors.
[5] Industry sources on biosimilar and generic manufacturing in oncology.
More… ↓
