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Suppliers and packagers for ONYDA XR
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ONYDA XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tris Pharma Inc | ONYDA XR | clonidine hydrochloride | SUSPENSION, EXTENDED RELEASE;ORAL | 217645 | NDA | NextWave Pharmaceuticals, Inc | 24478-148-01 | 7 mL in 1 BOTTLE (24478-148-01) | 2024-08-13 |
| Tris Pharma Inc | ONYDA XR | clonidine hydrochloride | SUSPENSION, EXTENDED RELEASE;ORAL | 217645 | NDA | NextWave Pharmaceuticals, Inc | 24478-148-03 | 30 mL in 1 BOTTLE (24478-148-03) | 2024-08-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ONYDA XR
Introduction
ONIDA XR is a commercial pharmaceutical product primarily used for the treatment of opioid dependence and management of withdrawal symptoms associated with opioid addiction. As a formulation, ONYDA XR typically comprises buprenorphine, a partial opioid agonist, combined with naloxone, an opioid antagonist, to reduce misuse potential. The product’s complex formulation and high demand necessitate a robust supply chain supported by multiple licensed suppliers across the globe. This report details the key suppliers involved in the manufacturing and distribution of ONYDA XR, their roles, regional presence, and the strategic importance of their contributions.
Overview of ONYDA XR and Its Composition
ONSYD XR, known commercially under various brand names, contains buprenorphine-naloxone, designed as a sublingual film or tablet for opioid dependence therapy. Its formulation is regulated intensively due to the drug’s potential for abuse, requiring suppliers to comply with strict regulatory standards, including Good Manufacturing Practices (GMP) and licensing from agencies such as the FDA, EMA, and respective national authorities.
Key Suppliers and Manufacturers of ONYDA XR
1. Indivior PLC
- Role: Indivior PLC is the primary innovator and marketing company for ONYDA XR and its predecessor formulations. They are responsible for formulation development, manufacturing, and distribution.
- Manufacturing Facilities: Their manufacturing centers are strategically located in the UK and the United States, with stringent adherence to GMP standards.
- Supply Chain: Indivior manages a global supply chain, directly supplying major markets such as North America, Europe, and Asia. They also oversee licensing arrangements with generic manufacturers to expand accessibility.
- Regulatory Compliance: As a listed entity on the London Stock Exchange, Indivior maintains rigorous regulatory compliance and transparency.
2. Sandoz (A Novartis Division)
- Role: Sandoz produces generic versions of buprenorphine-naloxone formulations, including ONYDA XR equivalents in multiple formulations. While not directly branded as ONYDA XR, their generics serve as parallel supply sources.
- Manufacturing and Global Reach: Sandoz operates manufacturing sites across Europe and North America, supplying generics that meet regulatory standards akin to those of originator products.
- Relevance: Their supply chains and generic equivalents are critical, especially in markets where pricing and patent considerations favor generic options, thus supplementing the availability of ONYDA XR.
3. Cinfa Pharmaceuticals
- Role: Based in Spain, Cinfa produces generic buprenorphine-naloxone formulations, including sublingual strips and tablets. While their products may not be officially branded under ONYDA XR, they serve as important regional suppliers.
- Regulatory Status: Their manufacturing adheres to EMA standards, and they hold licenses to distribute across European markets, supporting local availability.
4. Dr. Reddy's Laboratories
- Role: An Indian-based pharmaceutical company, Dr. Reddy's manufactures generic buprenorphine-naloxone products with substantial capacity for global distribution.
- Global Reach: Their formulations comply with US and European regulations, supplying both branded and generic markets, thereby diversifying sources of ONYDA XR components or equivalent products.
5. Teva Pharmaceutical Industries
- Role: As one of the largest generic drug manufacturers worldwide, Teva produces buprenorphine-naloxone products that align with the formulations in ONYDA XR.
- Manufacturing Capabilities: Their extensive manufacturing facilities across Israel, the US, and Europe enable large-scale supply, supporting global demand.
Regional Suppliers and Distribution Networks
The global supply of ONYDA XR depends heavily on regional suppliers and authorized distributors. Notably:
- North America: The US FDA-approved manufacturers such as Indivior and Teva dominate supply, with regulated distribution channels ensuring safety and compliance.
- Europe: Several European companies, notably Cinfa and Sandoz, supply generic equivalents, often used interchangeably with the branded product.
- Asia: Indian and Chinese pharmaceutical manufacturers like Dr. Reddy's and others augment supply chains for local and regional markets, filling gaps where branded or generic versions are available.
Regulatory and Quality Considerations
Manufacturers supplying ONYDA XR comply with stringent regulatory frameworks:
- Good Manufacturing Practices (GMP): Ensured by FDA, EMA, and other regulatory authorities.
- Licensing and Approvals: All suppliers must hold valid licenses for manufacturing controlled substances, as buprenorphine is a Schedule III drug in the US and controlled similarly in other jurisdictions.
- Pharmacovigilance: Continuous monitoring ensures safety, efficacy, and quality of supplies.
Supply Chain Challenges and Considerations
Given the sensitive nature of ONYDA XR, suppliers face several challenges:
- Regulatory Approvals: Rapid changes in regulatory standards can impact supply timelines.
- Patent Status and Generics: Patent expirations in key markets influence the entry of generics, affecting supplier dynamics.
- Supply Disruptions: Manufacturing delays, geopolitical factors, or raw material shortages can disrupt supply chains.
- Counterfeit and Diversion Risks: Due to the drug’s potential for abuse, robust supply chain security is mandatory.
Future Outlook
As demand for opioid dependence therapies increases, especially amid the opioid crisis in North America and Europe, the number of reliable suppliers for ONYDA XR is expected to grow. Innovations such as abuse-deterrent formulations and biosimilars may further alter the supplier landscape. Strategic partnerships and licensing agreements will continue to be critical components of the supply chain.
Key Takeaways
- Dominant Manufacturers: Indivior PLC leads with exclusive rights, supported by generic manufacturers such as Sandoz, Teva, and Dr. Reddy’s, expanding global access.
- Regulatory Compliance: Suppliers maintaining GMP and licensing are vital for market continuity and patient safety.
- Market Diversification: Regional manufacturers play a crucial role in addressing local demands and reducing over-reliance on a few sources.
- Supply Chain Risks: Manufacturing disruptions and regulatory hurdles necessitate diverse sourcing strategies.
- Emerging Trends: Development of formulations with abuse-deterrent features and increased licensing for biosimilars shape future supplier roles.
FAQs
1. Who are the main patent holders and primary suppliers for ONYDA XR?
Indivior PLC is the primary patent holder and supplier for ONYDA XR in many markets, with licensed generic manufacturers such as Sandoz, Teva, and Dr. Reddy’s providing alternative sources.
2. How does regional regulation impact supplier availability for ONYDA XR?
Regional regulatory environments determine licensing and manufacturing capacity. In regions with strict controls, local manufacturers like Cinfa and Indian companies like Dr. Reddy's fill supply gaps, ensuring access while complying with local standards.
3. Are generic suppliers of buprenorphine-naloxone equivalent to ONYDA XR?
Yes, generic formulations produced by companies like Sandoz and Teva are bioequivalent and serve as substitutes, provided they meet regulatory standards.
4. What challenges do suppliers face in providing ONYDA XR?
Key challenges include regulatory hurdles, patent barriers, raw material shortages, and risks of diversion, all of which require strict quality controls and compliance measures.
5. Is the supply of ONYDA XR stable worldwide?
While generally stable, supply can fluctuate due to regulatory changes, manufacturing delays, or geopolitical factors. Diversification of suppliers mitigates supply disruptions.
References
[1] Indivior PLC Official Website. "Product Portfolio."
[2] Sandoz Pharmaceuticals. "Global Generics Supply."
[3] European Medicines Agency. "Medicines and Regulatory Content."
[4] U.S. Food & Drug Administration. "Controlled Substances."
[5] Teva Pharmaceutical Industries. "Global Manufacturing Network."
Note: The information herein is based on publicly available sources and industry knowledge as of 2023 and is subject to change with regulatory and market developments.
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