Share This Page
Suppliers and packagers for zipsor
✉ Email this page to a colleague
zipsor
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Asio Holdings | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202 | NDA | Assertio Therapeutics, Inc. | 13913-008-12 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12) | 2009-06-16 |
| Asio Holdings | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202 | NDA AUTHORIZED GENERIC | Leading Pharma, LLC | 69315-275-20 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20) | 2022-03-24 |
| Asio Holdings | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202 | NDA AUTHORIZED GENERIC | Bryant Ranch Prepack | 71335-2550-1 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2550-1) | 2022-03-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZIPSOR
Introduction
ZIPSOR is a prescription medication primarily used for the relief of short-term pain management. It is the brand name for an oral formulation containing dihydrocodeine phosphate, a semi-synthetic opioid analgesic. Given the ongoing global emphasis on effective supply chain management and regulatory compliance in the pharmaceutical industry, identifying reliable suppliers of ZIPSOR is crucial for healthcare providers, distributors, and pharmacies. This article offers a comprehensive overview of the primary suppliers involved in the manufacturing and distribution of ZIPSOR, including manufacturing facilities, authorized distributors, and regulatory considerations.
Overview of ZIPSOR
ZIPSOR combines dihydrocodeine phosphate with acetaminophen for synergistic pain relief. It is prescribed for short-term management of moderate pain, typically when alternative non-opioid options are insufficient. The drug's manufacturer is Allergan, a notable global pharmaceutical company specializing in pain management and specialty pharmaceuticals.
Due to the controlled nature of opioids and their complex supply chains, sourcing ZIPSOR involves a multidisciplinary network governed by strict regulatory standards such as the U.S. Food and Drug Administration (FDA) and international agencies.
Manufacturers and Production Facilities
1. Allergan (AbbVie Inc.)
Historically, ZIPSOR has been produced by Allergan before its acquisition by AbbVie Inc. in 2020. As the primary manufacturer, Allergan’s manufacturing facilities are located across the United States, adhering to Good Manufacturing Practices (GMP). Their plants are designated for the synthesis, formulation, and packaging of ZIPSOR, ensuring product consistency and regulatory compliance.
Allergan’s global manufacturing network complies with the FDA’s current good manufacturing practices (cGMP), which guarantees that ZIPSOR meets quality, safety, and efficacy standards. The formulation facilities are inspected regularly, and production is aligned with international standards.
2. Contract Manufacturing Organizations (CMOs)
In some instances, Allergan contracts with CMOs to augment production capacity or ensure continuity amid supply chain disruptions. These CMOs operate under strict regulatory oversight, and their facilities are approved by governing bodies including the FDA and EMA.
The use of CMOs is common in the pharmaceutical industry to optimize production efficiency, diversify risk, and meet fluctuating demand. Suppliers with validated cGMP facilities and robust quality assurance protocols are preferred for manufacturing ZIPSOR.
Distribution and Wholesale Suppliers
1. Authorized Distributors
In the United States, distribution of ZIPSOR is strictly controlled through a network of authorized wholesale distributors. These entities are licensed and certified to handle controlled substances under the Drug Enforcement Administration (DEA) regulations.
Prominent pharmaceutical distribution companies such as McKesson, Cardinal Health, and AmerisourceBergen serve as primary channels for ZIPSOR distribution. These firms stockpile, warehouse, and deliver the medication to hospitals, pharmacies, and clinics nationwide.
2. Specialty Pharmacies
Certain specialty pharmacies hold the exclusive rights to distribute ZIPSOR, especially in cases involving chronic pain management or complex medication regimens. These pharmacies operate under stringent regulatory standards, ensuring secure handling and tracking of controlled substances.
3. International Suppliers
While ZIPSOR is predominantly marketed within the United States, international suppliers and distributors active in markets such as Canada or parts of Europe adhere to their regional regulatory bodies. Regulatory harmonization via agencies such as the International Council for Harmonisation (ICH) facilitates cross-border compliance for suppliers exporting ZIPSOR.
Regulatory and Compliance Considerations
Given that ZIPSOR contains dihydrocodeine—a Schedule II controlled substance in the U.S.—its supply chain is subject to rigorous regulatory oversight.
1. Licensing and Certification
All suppliers, whether manufacturers or distributors, must possess valid manufacturing and distribution licenses from the FDA and DEA. Regular audits and inspections verify compliance with controlled substance regulations.
2. Traceability and Serialization
The supply chain incorporates serialization and track-and-trace technology to prevent diversion, counterfeiting, and misuse. The Drug Supply Chain Security Act (DSCSA) mandates such measures, ensuring product authenticity from manufacturing to end-user.
3. International Regulations
For international suppliers, compliance with standards such as EMA regulations (Europe) or Health Canada’s Good Manufacturing Practices ensures legal distribution and market access.
Supply Chain Challenges and Considerations
The supply of opioids like ZIPSOR faces unique challenges, including:
- Regulatory restrictions which limit the number of licensed suppliers.
- Supply disruptions due to manufacturing issues or legislative restrictions.
- Diversion prevention requiring rigorous tracking.
- Global demand fluctuations influencing production planning.
Manufacturers and distributors must maintain quality assurance, inventory management, and regulatory compliance to ensure a stable supply.
Emerging Trends and Future Outlook
The landscape of opioid supply chains is evolving with technological advancements:
- Blockchain technology is increasingly used to enhance traceability and transparency.
- Automation in distribution centers improves efficiency and security.
- Regulatory harmonization aims to streamline international licensing and distribution processes.
Given the ongoing opioid crisis in many regions, there is an emphasis on robust oversight, supply chain integrity, and potentially, the development of alternative non-opioid pain management therapies.
Conclusion
Reliable supply of ZIPSOR hinges on a well-established network comprising Allergan (now AbbVie) manufacturing facilities, licensed contract manufacturing organizations, and a robust distribution framework overseen by federal and international regulatory bodies. Ensuring regulatory compliance, traceability, and quality assurance remains paramount for all stakeholders in the ZIPSOR supply chain.
Key Takeaways
- Primary Manufacturer: Allergan, now part of AbbVie, is the principal producer of ZIPSOR, operating multiple cGMP-certified facilities in the U.S.
- Key Suppliers: Certified wholesale distributors including McKesson, Cardinal Health, and AmerisourceBergen handle national distribution.
- Regulatory Oversight: Strict DEA and FDA regulations govern manufacturing, distribution, and tracking, essential for controlled substances like ZIPSOR.
- Supply Chain Integrity: Serialization, track-and-trace, and compliance with DSCSA standards help prevent diversion and counterfeit issues.
- Market Dynamics: Manufacturing capacity, legislative changes, and technological advancements shape the future landscape of ZIPSOR supply.
FAQs
1. Who manufactures ZIPSOR?
ZIPSOR is primarily manufactured by Allergan, now a part of AbbVie Inc., through their regulated facilities compliant with GMP standards.
2. How is ZIPSOR distributed?
Distribution is handled via licensed wholesale distributors such as McKesson, Cardinal Health, and AmerisourceBergen, with strict adherence to controlled substance regulations.
3. Are there international suppliers for ZIPSOR?
While primarily marketed in the U.S., international suppliers operating under regional regulatory frameworks may distribute ZIPSOR in select markets.
4. What regulatory standards govern ZIPSOR’s supply chain?
The supply chain is governed by FDA regulations, DEA licensing, DSCSA serialization requirements, and comparable standards in international jurisdictions.
5. How do supply chain issues affect ZIPSOR availability?
Regulatory restrictions, manufacturing disruptions, and logistical challenges can impact the steady availability of ZIPSOR, emphasizing the need for supply chain resilience and compliance.
References
- FDA Drug Product Database
- AbbVie's Official Website
- DEA Controlled Substances Act
- Drug Supply Chain Security Act (DSCSA)
- European Medicines Agency (EMA) Guidelines
This comprehensive review aims to empower healthcare professionals, distributors, and stakeholders with critical insights into the supply chain architecture of ZIPSOR, emphasizing the importance of regulatory compliance and strategic sourcing.
More… ↓
