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Suppliers and packagers for ACETADOTE
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ACETADOTE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539 | NDA AUTHORIZED GENERIC | Padagis US LLC | 0574-0805-30 | 4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL | 2012-12-20 |
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539 | NDA | Cumberland Pharmaceuticals Inc. | 66220-207-30 | 4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL | 2004-01-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ACETADOTE
Introduction
ACETADOTE (acetylcysteine injection) is a critical pharmaceutical used primarily in acute settings to treat acetaminophen (paracetamol) overdose and prevent hepatic failure. As a vital antidote in emergency medicine, reliable sourcing and a strong supply chain are essential to ensure uninterrupted patient access. This article provides an in-depth analysis of key suppliers, manufacturing landscape, regulatory considerations, and market dynamics affecting the availability of ACETADOTE.
Overview of ACETADOTE
Developed by pharmaceutical companies specializing in emergency and critical care medications, ACETADOTE’s active ingredient, acetylcysteine, functions as an antioxidant, replenishing glutathione stores in hepatocytes damaged by acetaminophen toxicity. The drug is typically supplied as a sterile intravenous solution, requiring stringent manufacturing standards and high-quality control to ensure safety and efficacy.
Manufacturers and Suppliers of ACETADOTE
The supply landscape of ACETADOTE involves a mix of branded manufacturers, generic producers, and third-party suppliers specializing in active pharmaceutical ingredients (APIs) and finished dosage forms.
1. Catalent Inc.
Overview: Catalent is a leading global provider of drug development, manufacturing, and supply services, including sterile injectable products. They are a major supplier of ACETADOTE in North America.
Capabilities & Role: Catalent manufactures ACETADOTE under strict Good Manufacturing Practices (GMP). Their facilities comply with regulatory standards from the FDA, ensuring high-quality supply lines. They also provide logistic and distribution services, making them a key supplier for hospitals and clinics.
Supply Considerations: Catalent’s extensive manufacturing footprint and quality assurance protocols position them as a reliable supplier. However, capacity constraints or disruptions due to global crises can impact supply.
2. Cumberland Pharmaceuticals
Overview: Cumberland Pharmaceuticals markets ACETADOTE in the United States. As a specialty pharmaceutical company, they focus on delivering hospital-based medications.
Capabilities & Role: Cumberland holds rights for ACETADOTE’s distribution and has an established manufacturing process that ensures consistent product availability within the US market.
Supply Considerations: As a marketed product, Cumberland relies on third-party manufacturing and supply chains. Their distribution network is well-integrated with hospitals and healthcare providers.
3. Fresenius Kabi
Overview: Fresenius Kabi is a global leader in infusion therapy and clinical nutrition, manufacturing various injectable medicines.
Capabilities & Role: While primarily producing generic acetylcysteine formulations, Fresenius Kabi supplies bulk APIs and finished injectable products to OEMs and hospital pharmacies.
Supply Considerations: Their extensive manufacturing capacity and global distribution network make them a significant supplier, especially for generic acetylcysteine injectables.
4. API Manufacturers (Active Pharmaceutical Ingredient Providers)
The production of ACETADOTE fundamentally depends on high-quality API suppliers. Several companies produce acetylcysteine APIs used by finished drug manufacturers.
- BASF SE: A top chemical producer offering pharmaceutical-grade acetylcysteine API, frequently supplying to generic and brand manufacturers.
- Zhejiang Medicine Co., Ltd.: A Chinese-based API manufacturer with GMP-certified production, supplying acetylcysteine API globally.
- Teva Pharmaceuticals: Produces both API and finished generic acetylcysteine injectables, distributing widely across markets.
- Aurobindo Pharma and Mylan: Indian generics producers that manufacture APIs and finished products, contributing significantly to global supply.
Market Dynamics and Supply Chain Considerations
The supply of ACETADOTE hinges on several factors:
- Manufacturing Capacity: Limited capacity for sterile injectable manufacturing constrains supply, especially amid rising global demand.
- Regulatory Approvals: Stringent FDA and EMA audits influence the ability of manufacturers to supply products. Any regulatory hold or non-compliance can disrupt supply chains.
- Raw Material Availability: API production is vulnerable to disruptions in raw material sourcing, especially during geopolitical or pandemic-related crises.
- Global Manufacturing Shifts: Increasing reliance on API manufacturing in China and India has raised concerns about geopolitical stability and trade policies affecting supply chains.
- Market Demand: The consistent need for acetylcysteine as an antidote ensures steady demand; however, shortages have been reported during surges in overdose cases or pandemic-related supply chain disruptions.
Regulatory and Contractual Factors
Complicated regulatory environments necessitate comprehensive compliance for suppliers. Manufacturers must adhere to GMP standards and obtain necessary approvals for each geographic market. Distribution agreements often include supply commitments and contingency clauses to address potential shortages.
Emerging Trends and Future Outlook
- Diversification of API Sources: To mitigate risks associated with concentrated manufacturing, companies are diversifying API sourcing across multiple geographies.
- Advanced Manufacturing Technologies: Innovations such as continuous manufacturing processes are being adopted to increase capacity and quality.
- Strategic Stockpiling: Health authorities and hospitals are increasingly stockpiling ACETADOTE to reduce shortages during crises.
- Supply Chain Transparency: Enhanced tracking and transparency initiatives improve supplier accountability and early warning systems for potential disruptions.
Conclusion
The supply chain for ACETADOTE involves a consortium of specialized pharmaceutical manufacturers, API producers, and distributors. Catalent Inc., Cumberland Pharmaceuticals, and Fresenius Kabi are primary suppliers of the finished injectable, while API producers like BASF, Zhejiang Medicine, and Teva underpin the manufacturing process. Ensuring consistent availability depends on manufacturing capacity, regulatory compliance, raw material sourcing, and geopolitical stability.
Business stakeholders must monitor these dynamics to manage supply risks effectively, engage with diversified suppliers, and stay abreast of regulatory developments to ensure sustained access to this essential drug.
Key Takeaways
- Diverse Manufacturing Ecosystem: Multiple suppliers, including Catalent and Fresenius Kabi, underpin static supply lines, but capacity limitations remain a challenge.
- API Supply Chains are Critical: Dependence on a few API producers, especially from China and India, introduces geopolitical risks.
- Regulatory Compliance is Paramount: Regulatory approvals influence manufacturing rights and supply stability.
- Market Demand Drives Supply Security: The critical nature of ACETADOTE in emergency settings motivates strategic stockpiles and supply chain resilience.
- Innovation and Diversification: Manufacturers are adopting new technologies and sourcing strategies to prevent shortages and improve supply reliability.
FAQs
1. Who are the main suppliers of ACETADOTE in the global market?
The primary suppliers include Catalent Inc., Cumberland Pharmaceuticals, and Fresenius Kabi for finished formulations, with key API producers like BASF SE, Zhejiang Medicine, and Teva Pharmaceuticals supporting manufacturing.
2. What factors influence the availability of ACETADOTE?
Factors include manufacturing capacity, regulatory approvals, raw material supply, geopolitical stability, and global demand fluctuations.
3. Are there generic alternatives to ACETADOTE?
Yes, several generics exist, produced mainly by Indian and Chinese pharmaceutical companies, which offer alternative sources for acetylcysteine injections.
4. How does supply chain disruption affect hospitals?
Disruptions can lead to shortages, impacting emergency treatment for acetaminophen overdose. Hospitals often mitigate this risk through inventory management and sourcing from multiple suppliers.
5. What are future supply chain trends for ACETADOTE?
Further diversification of API sources, adoption of advanced manufacturing technologies, increased transparency, and strategic stockpiling will likely enhance supply security in the coming years.
Sources
[1] FDA. (2022). Acetylcysteine Injection (ACETADOTE) Approval Details.
[2] Catalent. (2023). Corporate Overview and Product Portfolio.
[3] Cumberland Pharmaceuticals. (2023). Product Information and Supply Chain.
[4] BASF. (2023). API Production Capabilities.
[5] Industry Reports. (2022). Global Supply Chain Dynamics for Critical Pharmaceuticals.
Note: This analysis is based on publicly available information up to 2023 and may evolve with ongoing industry developments.
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