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Suppliers and packagers for methadose
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methadose
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | SpecGx LLC | 0406-0527-10 | 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10) | 1973-03-14 |
| Specgx Llc | METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | SpecGx LLC | 0406-8725-10 | 1000 mL in 1 BOTTLE, PLASTIC (0406-8725-10) | 1973-03-14 |
| Specgx Llc | METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | ATLANTIC BIOLOGICALS CORP. | 17856-0526-1 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0526-1) / .5 mL in 1 SYRINGE | 2019-05-14 |
| Specgx Llc | METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | ATLANTIC BIOLOGICALS CORP. | 17856-0526-2 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0526-2) / 1 mL in 1 SYRINGE | 2019-05-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Methadose
Introduction
Methadose, a branded formulation of methadone, is a crucial medication used primarily in opioid substitution therapy (OST). It helps manage opioid dependence, reducing withdrawal symptoms and cravings. As a Schedule II controlled substance in the United States, methadone’s production, supply chain, and distribution are tightly regulated. Ensuring a reliable supply of Methadose demands a comprehensive understanding of its authorized suppliers, manufacturing landscape, regulatory frameworks, and key market players.
This article explores the primary suppliers of Methadose, emphasizing the landscape's complexity, regulatory considerations, manufacturing networks, and implications for healthcare providers, policymakers, and pharmaceutical distributors.
Regulatory Landscape and Market Authorization
The production and distribution of Methadose in the United States are overseen by the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA). The drug's classification as a Schedule II substance necessitates strict adherence to regulatory protocols, including manufacturing licenses, batch tracking, and secure distribution channels. Only licensed manufacturers with FDA approval can produce Methadose for medical use.
In addition, the Drug Addiction Treatment Act (DATA) of 2000 permits specific practitioners and pharmacies to dispense methadone for OST, further shaping the supplier landscape.
Major Manufacturers and Suppliers of Methadose
1. Roxane Laboratories, Inc.
Roxane Laboratories, a division of Boehringer Ingelheim, is a significant U.S. provider of methadone formulations, including Methadose. They manufacture methadone tablets for opioid treatment programs (OTPs). Roxane's extensive manufacturing facilities are FDA approved, with robust distribution channels directed primarily toward licensed opioid treatment clinics.
2. Hikma Pharmaceuticals
Hikma Pharmaceuticals, a global generic drug manufacturer headquartered in London, is among the notable suppliers of methadone in the United States and international markets. Their portfolio includes methadone hydrochloride tablets, which are marketed under various brand names, including Methadose in some regions. Hikma's manufacturing facilities are FDA-approved, ensuring compliance with pharmaceutical standards.
3. Sandoz (Novartis)
Sandoz, a division of Novartis, supplies generic methadone formulations globally, including in the United States. Their production adheres to stringent regulatory standards, and they distribute to licensed clinics and pharmacies. Sandoz's role as a major generics producer positions it as a key supplier of methadone products like Methadose.
4. Dr. Reddy’s Laboratories
While primarily known for other generics, Dr. Reddy’s Laboratories has facilities approved by the FDA for manufacturing controlled substances, including methadone. They supply pharmaceutical companies and OST clinics with approved methadone formulations for opioid dependence treatment.
Specialized Suppliers and Distributors
Apart from manufacturing companies, a network of licensed distributors plays a vital role in ensuring supply chain integrity for Methadose. These entities are responsible for warehousing, transportation, and distribution to clinics, pharmacies, and hospitals.
1. Cardinal Health
A leading pharmaceutical distributor, Cardinal Health, handles controlled substances including methadone. They operate under strict DEA regulations, maintaining rigorous security measures to prevent diversion. Their extensive distribution network ensures supply consistency across healthcare settings.
2. McKesson Corporation
Another major entity, McKesson, distributes methadone formulations to authorized clinics and pharmacies across the U.S. Their distribution systems are compliant with DEA and FDA regulations, ensuring traceability and security in the supply chain.
3. AmerisourceBergen
AmerisourceBergen provides distribution services for methadone and related controlled substances, emphasizing security and regulatory compliance. They work with licensed manufacturers and clinics, supporting the seamless supply chain for opioid dependence medications.
Challenges in the Methadose Supply Chain
Regulatory Compliance and Security
Due to its classification, methadone’s production and distribution involve rigorous oversight. Any breach, diversion, or contamination can result in severe legal penalties and health risks. This restricts the number of authorized suppliers, creating a limited but tightly controlled network.
Manufacturing Capacity and Market Demand
The rising opioid dependency crisis has increased demand for methadone medications like Methadose. However, manufacturing capacity constraints, coupled with regulatory hurdles, limit production scalability. Disruptions—such as FDA compliance issues or supply chain interruptions—can lead to shortages.
Diversion and Theft Risks
Methadone’s high abuse potential raises concerns about diversion. Suppliers implement strict security measures, track-and-trace systems, and secure transport protocols to mitigate risks. Nonetheless, illicit markets continue to pose challenges to the integrity of the supply chain.
Emerging trends and the role of biosimilars
While methadone is primarily produced by generic manufacturers, ongoing research explores alternative formulations, including long-acting injectable versions and biosimilars. These developments could diversify the supplier landscape over the coming years, potentially improving supply stability and patient compliance.
Regulatory and Market Outlook
The supply of Methadose remains influenced by regulatory policies aimed at curbing misuse and diversion. As the opioid epidemic persists, policymakers may streamline regulatory processes for manufacturers to enhance capacity, but safety remains paramount.
The global market expansion of generic manufacturers like Hikma and Sandoz signals a competitive landscape, with potential implications for price, availability, and quality standards. Additionally, the transition to more innovative formulations might reshape supply chains.
Key Players Summary
| Manufacturer/Distributor | Role | Regulatory Status | Market Focus |
|---|---|---|---|
| Roxane Laboratories | Major producer of methadone tablets | FDA-approved | U.S. opioid treatment clinics |
| Hikma Pharmaceuticals | Global generic methadone supply | FDA-approved | U.S. and international markets |
| Sandoz (Novartis) | Generic methadone provider | FDA-approved | Global markets |
| Dr. Reddy’s Laboratories | Controlled substance manufacturer | FDA-approved | Selected markets |
| Cardinal Health | Distributer | DEA compliant | U.S. clinics and pharmacies |
| McKesson | Distributer | DEA compliant | U.S. clinics, pharmacies |
| AmerisourceBergen | Distributer | DEA compliant | U.S. healthcare providers |
Conclusion
The supply chain of Methadose hinges on a few key licensed manufacturers and distributors operating under strict regulatory frameworks. Roxane Laboratories, Hikma Pharmaceuticals, and Sandoz are prominent domestic and international suppliers, complemented by sophisticated distribution networks from Cardinal Health, McKesson, and AmerisourceBergen. Ensuring consistent and secure supply requires ongoing regulatory vigilance amid rising demand and the need for innovation in formulations.
Key Takeaways
- The production and distribution of Methadose are tightly regulated, involving a small group of licensed manufacturers and distributors.
- Major suppliers like Roxane, Hikma, and Sandoz provide the foundation for the U.S. market, with global implications.
- Distribution is handled by large, DEA-compliant entities, emphasizing security and traceability.
- Supply challenges include capacity constraints, regulatory hurdles, and diversion risks.
- Emerging formulations and biosimilars may diversify future supply sources and enhance availability.
FAQs
1. Who are the primary domestic manufacturers of Methadose in the United States?
Roxane Laboratories (a division of Boehringer Ingelheim) and Hikma Pharmaceuticals are among the leading domestic manufacturers supplying methadone formulations like Methadose within the United States, serving licensed opioid treatment programs.
2. How does regulatory oversight impact the supply chain of Methadose?
Strict FDA and DEA regulations limit the number of licensed manufacturers and distributors, enforcing compliance through security measures, batch tracking, and secure transportation to prevent diversion and ensure product safety.
3. Are international suppliers significant in the Methadose market?
Yes. Companies like Hikma and Sandoz, headquartered outside the U.S., supply generic methadone formulations internationally and in certain cases domestically, leveraging global manufacturing facilities approved by regulators.
4. What are the primary challenges faced by Methadose suppliers?
Key challenges include regulatory compliance, capacity limitations to meet rising demand, preventing diversion and theft, and maintaining product quality across the supply chain.
5. How might the supply landscape of Methadose evolve in the future?
Advancements in formulation, such as long-acting injectables and biosimilars, could diversify suppliers and improve supply resilience. Increased regulatory focus on manufacturing capacity and security might streamline or complicate future supply routes.
References
[1] U.S. Food & Drug Administration. (2022). Approved Drugs: Methadone.
[2] Drug Enforcement Administration. (2023). Controlled Substances Schedules.
[3] Boehringer Ingelheim. (2021). Roxane Laboratories’ Methadone Products.
[4] Hikma Pharmaceuticals. (2022). Global Generics Portfolio & Regulatory Approvals.
[5] Sandoz. (2022). Generic Methadone Distribution and Compliance.
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