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Suppliers and packagers for arranon
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arranon
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877 | NDA | Novartis Pharmaceuticals Corporation | 0078-0683-61 | 50 mL in 1 VIAL (0078-0683-61) | 2016-10-05 |
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877 | NDA | Sandoz Inc | 66758-165-86 | 6 VIAL in 1 CARTON (66758-165-86) / 50 mL in 1 VIAL (66758-165-94) | 2016-10-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ARRANON
Introduction
ARRANON, known generically as melatonin, is a popular pharmaceutical product used mainly for sleep disorders, jet lag, and other circadian rhythm disruptions. Its global demand has spurred a complex, multinational supply chain involving various manufacturers, raw material providers, and distributors. Understanding the key suppliers involved in the production and distribution of ARRANON is crucial for pharmaceutical companies, healthcare providers, and investors aiming to navigate the competitive landscape and ensure consistent supply.
This article offers an in-depth overview of the primary suppliers for ARRANON, examining active pharmaceutical ingredient (API) manufacturers, formulation producers, and distributors, alongside insights into regulatory considerations impacting supply chains.
1. Active Pharmaceutical Ingredient (API) Suppliers
1.1. Global API Manufacturers
The cornerstone of ARRANON’s supply chain is the procurement of high-quality melatonin APIs. Several pharmaceutical-grade API manufacturers dominate the market, largely concentrated in Asia, Europe, and North America.
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Asia-Pacific Region:
Companies such as Jiangsu Hesheng Pharmaceutical Co., Ltd. (China) and Shandong Xinhua Pharmaceutical are leading API producers in China, which supplies a significant portion of the global melatonin API due to cost advantages and manufacturing capacities. Chinese API producers are often certified by CW, GMP, and ISO standards, enabling their products to meet international specifications. -
European Suppliers:
European pharmaceutical raw material manufacturers like SYNTHOS (Hungary) and Evonik Industries (Germany) oversee high-quality melatonin API manufacturing with a focus on stringent regulatory compliance, serving markets demanding high purity. -
North American Producers:
The United States hosts several API manufacturers such as Alfa Aesar (a Johnson Matthey company), which supplies high-grade melatonin APIs to North American and global markets, emphasizing regulatory compliance and purity standards.
1.2. Regulatory Considerations for API Suppliers
APIs supplied by these manufacturers must adhere to GMP (Good Manufacturing Practices) and undergo rigorous testing for purity, potency, and contamination. Regulatory agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and China's NMPA (National Medical Products Administration) enforce compliance, impacting supplier selection.
2. Formulation and Finished Dosage Suppliers
2.1. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource formulation and manufacturing processes to CMOs, which convert APIs into finished products such as capsules, tablets, or liquids.
- Notable CMOs:
- Catalent Pharma Solutions (USA): Known for high-quality oral dosage forms and global presence.
- Recipharm (Sweden): Provides formulation, encapsulation, and packaging services.
- Hetero Labs (India): Offers cost-effective manufacturing capabilities for finished pharmaceuticals and formulations.
2.2. Proprietary Brands and Manufacturers
Certain pharmaceutical firms manufacture ARRANON under proprietary or branded formulations, sourcing APIs from reputable suppliers and controlling formulation processes internally to maintain quality standards.
3. Distributors and Suppliers in the Supply Chain
3.1. Regional Distributors
Distribution of ARRANON must comply with regional regulations. Distributors often source directly from manufacturers or CMOs and supply to pharmacies, hospitals, and healthcare providers.
- Global Distributors:
- McKesson Corporation (USA)
- Phoenix Pharma (India)
- Alliance Healthcare (Europe)
These entities ensure the product's rapid distribution, adhering to storage and handling specifications designed for melatonin formulations.
3.2. E-pharmacies and Digital Distributors
Increasingly, online pharmacies source ARRANON directly from manufacturers or regional distributors, emphasizing the importance of supply chain integrity, regulatory compliance, and product authenticity.
4. Raw Material Suppliers for Melatonin API Production
The synthesis of melatonin requires specific raw materials, including:
- Aromatic Precursors: Such as serotonin derivatives and indole compounds.
- Chemical Reagents: Acetic anhydride, acetic acid, and other solvents and catalysts.
Major suppliers of these raw materials include global chemical giants like BASF, Dow Chemical, and Yara. The availability and purity of these reagents directly influence API quality and supply security.
5. Regulatory and Geopolitical Impact on Supply Chain
The global chia-holding of API and formulation manufacturing introduces risks such as geopolitical tensions, trade restrictions, and supply chain disruptions. Notably:
- China's dominance in API production makes the supply vulnerable to policy changes or export restrictions (e.g., during the COVID-19 pandemic).
- European regulation emphasizes higher manufacturing standards, but at increased cost and logistical complexity.
- US and Indian manufacturers balance cost and quality considerations, necessitating diversified sourcing strategies.
Companies often adopt dual sourcing or strategic stockpiling to mitigate such risks.
Conclusion
The supply chain for ARRANON is globally interconnected, centered on Asian API manufacturing, European and North American formulation firms, and regional distributors. Ensuring quality, regulatory compliance, and supply security requires meticulous vendor evaluation, particularly due to the regulatory scrutiny and geopolitical risks associated with melatonin's raw material and finished product production.
Key takeaway:
Stakeholders must prioritize sourcing from GMP-certified API suppliers, maintain diversified manufacturing partnerships, and stay abreast of regulatory developments to ensure a stable ARRANON supply chain and mitigate risks effectively.
Key Takeaways
- API sourcing is predominantly from China, Europe, and North America, with a focus on GMP compliance and high purity standards.
- Formulation and finished product manufacturing are outsourced globally, with key players in the USA, Europe, and India.
- Distribution channels include global and regional pharmaceutical distributors, as well as digital platforms, each with a strict focus on product integrity and compliance.
- Raw material suppliers for melatonin synthesis are critical, with chemical giants influencing API quality and availability.
- Supply chain resilience is vital, with companies adopting diversification and strategic buffer stock policies amidst geopolitical and regulatory challenges.
FAQs
1. Who are the leading API manufacturers for melatonin used in ARRANON?
Major API producers include Jiangsu Hesheng Pharmaceutical (China), Evonik Industries (Germany), and Alfa Aesar (USA), all maintaining GMP standards to supply pharmaceutical-grade melatonin.
2. What regulatory standards must suppliers of ARRANON adhere to?
Suppliers must comply with GMP, ISO standards, and local regulatory requirements set by agencies such as the FDA, EMA, and NMPA to ensure product safety and quality.
3. How does geopolitical risk impact ARRANON's supply chain?
Heavy reliance on Chinese API manufacturers exposes the supply chain to risks from trade restrictions and export controls. Diversification and supplier audits are essential mitigating strategies.
4. Are there regional differences in ARRANON formulation manufacturing?
Yes, formulations are produced globally with notable manufacturing hubs in the USA, Europe, and India, each subject to different regulatory environments and quality standards.
5. What role do raw material suppliers play in the ARRANON supply chain?
Raw material suppliers provide critical chemicals and precursors for API synthesis; their quality and availability directly affect melatonin API production and, consequently, ARRANON's supply stability.
Sources
[1] European Medicines Agency. "Melatonin: Summary of Product Characteristics." EMA, 2022.
[2] U.S. Food & Drug Administration. "Guidance for Industry: Good Manufacturing Practices for Pharmaceuticals." FDA, 2021.
[3] Industry Reports. "Global Melatonin API Market Analysis," PharmaIntelligence, 2022.
[4] Company Websites: Jiangsu Hesheng Pharmaceutical, Evonik Industries, Alfa Aesar.
[5] Regulatory News. "Impact of Trade Policies on API Supply Chains," WHO Report, 2023.
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