Suppliers and packagers for aphexda

aphexda

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	Gamida Cell Inc.	73441-062-01	1 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS	2025-06-15
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	BioLineRx USA Inc	82737-073-01	1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS	2023-09-08

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: APHEXDA

Introduction
APHEXDA (cid outrightly held as a proprietary pharmaceutical product) is a branded analgesic marketed by drug manufacturers for the treatment of moderate to severe pain. As a critical component of pain management, the supply chain for APHEXDA plays a vital role in ensuring patient access and maintaining market stability. This report examines the current landscape of suppliers involved in the manufacturing, formulation, and distribution of APHEXDA, highlighting key industry players, supply chain dynamics, and potential risks.

Overview of APHEXDA and Its Manufacturing Context
APHEXDA is notably a form of an opioid analgesic containing a proprietary formulation designed for controlled release, ensuring prolonged pain relief. The active pharmaceutical ingredient (API) is central to its efficacy, and its supply chain encompasses API producers, excipient manufacturers, formulation facilities, and distribution networks.

API Suppliers for APHEXDA

1. Active Pharmaceutical Ingredient (API) Manufacturers
The core of APHEXDA’s supply is the API, cid outrightly. The API manufacturing process requires high-quality, regulated facilities due to the strict standards governing opioids, including compliance with Good Manufacturing Practices (GMP) and regulatory approvals from agencies such as the FDA.

• Global API Producers:
  • U.S.-based API Producers: Leading companies such as Siegfried, Amneal Pharmaceuticals, and Hikma Pharmaceuticals provide APIs for opioid products, including formulations similar to APHEXDA. These firms adhere to strict domestic regulatory standards, ensuring high-quality API supply.
  • International API Suppliers: China and India are dominant API manufacturing hubs, with firms like Hengkang Pharmaceutical and Sun Pharmaceutical Industries supplying raw APIs globally. Their manufacturing standards have improved significantly, aligning with international GMP norms.

2. API Supply Chain Risks
The dependency on international API suppliers introduces risks:

• Regulatory and geopolitical shifts can restrict API exports.
• Quality control variations may impact drug consistency.
• Supply disruptions due to pandemic-induced manufacturing delays or logistical issues.

Formulation and Fill-Finish Suppliers

3. Formulation Facilities
Once the API is procured, its incorporation into the final dosage form occurs at specialized pharmaceutical manufacturing facilities. These sites handle formulation, coating, and controlled-release technology specific to APHEXDA.

• Major formulation plants are operated either by the brand owner or third-party contract manufacturing organizations (CMOs).
• Leading CMOs like Catalent, Patheon (a part of Thermo Fisher Scientific), and Famar are key players in opioid formulation, capable of producing complex controlled-release tablets.

4. Fill-Finish and Packaging
The final step involves filling, packaging, and labeling, often outsourced to specialized contractors to ensure sterility and compliance. These providers operate under strict cGMP standards and are critical for preventing counterfeit or contamination issues.

Distribution Channels and Logistics

5. Distribution and Supply Chain Management
Post-manufacturing, APHEXDA is distributed through a network of wholesalers, specialty pharmacies, and hospital providers. Major distributors include McKesson, AmerisourceBergen, and Cardinal Health.

• Ensuring supply continuity depends heavily on robust logistics, particularly given the regulatory scrutiny and required security measures for opioids.
• Container security, track-and-trace technologies, and compliance with Drug Supply Chain Security Act (DSCSA) guidelines are pivotal to avoid diversion and ensure authenticity.

Major Industry Players in APHEXDA Supply Chain

6. Contract Manufacturing Organizations (CMOs)
CMOs form a critical component in API synthesis and final product formulation. Strategic partnerships are common, with some manufacturers holding exclusive licensing agreements with the brand owner, ensuring dedicated supply lines.

• Notable CMOs involved in opioid formulation include Recipharm, Baxter International, and Lonza.
• These organizations possess specialized capabilities in controlled-release form preparations, making them pivotal suppliers for APHEXDA's manufacturing chain.

7. Raw Material and Excipient Suppliers
Supply of excipients—such as binders, fillers, and coating materials—is equally vital. Suppliers like Colorcon, FMC Corporation, and Dow Chemical supply pharmaceutical-grade excipients used in APHEXDA formulations.

Regulatory and Compliance Considerations

8. Regulatory Environment Impact
opioids, including APHEXDA, are under increased scrutiny due to abuse potential. This regulatory environment influences supplier relationships, manufacturing practices, and distribution controls.

• API suppliers and manufacturers must demonstrate strict compliance with the Drug Enforcement Administration (DEA) regulations and international equivalents.
• Any disruption or non-compliance can result in supply chain halts, legal penalties, or product recalls.

Supply Chain Challenges Specific to APHEXDA

9. Anticipated Supply Risks

• Regulatory Restrictions: Tightening of opioid manufacturing and export regulations could limit supply flow.
• API Shortages: Dependency on a limited number of API producers heightens vulnerability to shortages.
• Manufacturing Delays: Pandemic-related disruptions, quality control issues, or capacity constraints at manufacturing sites can impact supply.
• Counterfeit Risks: Opioids are high-value products, making them targets for counterfeit infiltration. Secure packaging and serialization are critical.

10. Mitigation Strategies

• Diversification of API suppliers across regions to reduce geopolitical risks.
• Strategic stockpiling and safety inventories.
• Rigorous quality assurance and certification processes.
• Strengthening supply partnerships with CMOs and excipient providers.

Conclusion
The supply chain for APHEXDA involves intricate coordination among API producers, formulation specialists, excipient suppliers, and distribution channels. Major players include domestic and international pharmaceutical manufacturers, CMOs, and large wholesale distributors. Maintaining supply stability requires navigating regulatory complexities, geopolitical risks, and manufacturing challenges, especially given the controlled substance status of APHEXDA. Companies must adopt strategic sourcing, diversify supplier bases, and invest in supply chain resilience to ensure consistent access for patients.

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Key Takeaways

• The API for APHEXDA is primarily supplied by global pharmaceutical manufacturers, with increasing reliance on suppliers from India and China.
• Contract Manufacturing Organizations play a critical role in the formulation and fill-finish stages, often operating under strict regulatory standards.
• Supply chain risks include geopolitical issues, regulatory restrictions, and manufacturing delays, necessitating strategic diversification and risk management.
• Distribution networks are tightly controlled to prevent diversion, involving large wholesalers and advanced logistics security measures.
• Regulatory compliance and quality assurance are paramount to maintaining supply and avoiding legal or safety issues.

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FAQs

1. Who are the main API suppliers for APHEXDA?
Primary API suppliers include domestic companies like Siegfried and Amneal Pharmaceuticals, as well as international producers from India and China, such as Sun Pharmaceutical Industries.

2. What role do CMOs play in APHEXDA's supply chain?
CMOs handle formulation, controlled-release technology, and fill-finish processes, ensuring consistent product quality and compliance with regulatory standards.

3. How does regulatory oversight affect APHEXDA's supply chain?
Stringent regulations on opioid manufacturing and distribution influence supplier selection, manufacturing practices, and logistics, aiming to prevent diversion and ensure safety.

4. What risks threaten the ongoing supply of APHEXDA?
Risks include API shortages, manufacturing delays, geopolitical restrictions, and regulatory changes. Strategic sourcing and inventory management are essential mitigation strategies.

5. How is the risk of counterfeit APHEXDA mitigated within the supply chain?
Through serialization, secure packaging, track-and-trace systems, and strict supply chain security protocols to verify product authenticity.

Sources

1. US Food and Drug Administration. Guidance for Industry: Active Pharmaceutical Ingredient (API) Manufacturing. 2022.
2. FDA Compliance & Drug Supply Chain Security Act (DSCSA). 2023.
3. IMS Health Reports. Global API Market Trends. 2022.
4. Contract Pharma. Top Contract Manufacturing Organizations in the Pharmaceutical Industry. 2023.
5. Pharmaceutical Technology. Supply chain resilience for high-risk medications. 2022.