Share This Page
Suppliers and packagers for generic pharmaceutical drug: BUPRENORPHINE HYDROCHLORIDE
✉ Email this page to a colleague
BUPRENORPHINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932 | NDA | BioDelivery Sciences International Inc | 59385-021-60 | 60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) | 2017-09-01 |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932 | NDA | BioDelivery Sciences International Inc | 59385-022-60 | 60 POUCH in 1 CARTON (59385-022-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01) | 2017-10-01 |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932 | NDA | BioDelivery Sciences International Inc | 59385-023-60 | 60 POUCH in 1 CARTON (59385-023-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-023-01) | 2017-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Buprenorphine Hydrochloride
Introduction
Buprenorphine hydrochloride is a semi-synthetic opioid analgesic widely used in pain management and opioid dependence treatment. Its unique pharmacological profile, which includes partial agonism at the mu-opioid receptor and antagonism at the kappa-opioid receptor, has positioned it as a crucial component in tackling opioid addiction and managing moderate to severe pain. As demand continues to rise globally, identifying reliable suppliers of buprenorphine hydrochloride becomes essential for pharmaceutical companies, healthcare providers, and policymakers. This article provides an in-depth overview of key suppliers, their geographic distribution, manufacturing capabilities, and regulatory considerations influencing procurement.
Global Market Overview
The market for buprenorphine hydrochloride is characterized by a limited number of primary manufacturers, driven by stringent regulatory controls, complex synthesis processes, and quality assurance standards. Predominantly, the supply chain involves large pharmaceutical companies with advanced R&D capabilities, specialty chemical producers, and Contract Manufacturing Organizations (CMOs). Emerging regions, notably Asia, have notably expanded their manufacturing capacity to meet increasing global demands.
Key Suppliers of Buprenorphine Hydrochloride
1. Indivior (UK & US)
Indivior is a leading pharmaceutical company specializing in addiction treatment medications. Its flagship products include Subutex and Suboxone, which contain buprenorphine. While the company primarily focuses on finished dosage formulations, it also supplies pharmaceutical-grade buprenorphine hydrochloride to licensed manufacturers. Indivior’s manufacturing facilities are GMP-compliant, ensuring high-quality standards that meet international regulatory requirements.
2. Böhringer Ingelheim (Germany)
Böhringer Ingelheim, a global pharmaceutical giant, is known for its extensive portfolio of specialty medications, including controlled substances like buprenorphine. The company produces bulk active pharmaceutical ingredients (APIs), including buprenorphine hydrochloride, primarily for markets in Europe and North America. Their manufacturing processes adhere strictly to Good Manufacturing Practices (GMP), with robust quality control protocols.
3. Hikma Pharmaceuticals (UK & Middle East)
Hikma manufactures generic medications, including buprenorphine products, with manufacturing plants in the Middle East and Europe. They supply both finished formulations and active ingredients to various markets, focusing on cost-effective production without compromising quality. Hikma’s strategic investments in API synthesis have strengthened their capacity to supply buprenorphine hydrochloride reliably across different regions.
4. Zhejiang Gensci Pharmaceutical (China)
Based in China, Zhejiang Gensci is an emerging supplier of APIs, including buprenorphine hydrochloride. The company benefits from China's rapidly expanding pharmaceutical manufacturing sector, offering competitive prices and high-volume production capabilities. Standards compliance with the FDA and EMA has been an ongoing focus, facilitating exports to Western markets.
5. Respect Pharmaceuticals (India)
Respect Pharmaceuticals specializes in APIs for pain management and addiction therapy. The Indian pharmaceutical sector is a significant global API supplier, and Respect Pharmaceuticals leverages this position by providing quality buprenorphine hydrochloride compliant with global regulatory standards. Their manufacturing plants operate under strict GMP conditions, with approvals from agencies like the USFDA and WHO.
6. Contract Manufacturing Organizations (CMOs)
Several global CMOs provide custom synthesis and manufacturing of buprenorphine hydrochloride, including:
- Thermo Fisher Scientific: Offers contract synthesis services, leveraging advanced technology for high purity APIs.
- Patheon (a part of Thermo Fisher): Provides manufacturing of APIs, including controlled substances, adhering to international regulatory frameworks.
- Sepor (India): An API supplier focusing on large-scale synthesis with GMP compliance.
These organizations supply to pharmaceutical firms seeking specialized manufacturing capacities, often enabling rapid scalability and consistent quality.
Regulatory Considerations
Given that buprenorphine hydrochloride is classified as a controlled substance (Schedules III or IV depending on jurisdiction), suppliers must comply with strict regulations. This includes adherence to Drug Enforcement Agency (DEA) regulations in the US, European Medicines Agency (EMA) standards in the EU, and comparable regulators worldwide. Export licenses, controlled substance registrations, and regular audits are mandatory, influencing supplier selection.
Quality assurance remains paramount. Suppliers often hold certifications such as:
- FDA approval or inspection
- European GMP certification
- WHO GMP certification
- ISO certifications (e.g., ISO 9001, ISO 14001)
Procurement decisions must prioritize suppliers with proven compliance records and transparent quality documentation, critical for regulatory approvals of finished medicinal products.
Supply Chain Dynamics and Challenges
The supply chain for buprenorphine hydrochloride is sensitive to various factors:
- Regulatory Constraints: Stringent controls can limit manufacturing output and global distribution.
- Raw Material Availability: Dependence on precursor chemicals such as thebaine influences production stability.
- Political and Trade Barriers: Export restrictions or sanctions can disrupt supply, especially from regions with geopolitical tensions.
- Intellectual Property: Patent protections may restrict generic manufacturing in certain markets.
- Manufacturing Capacity: Limited capacity can lead to supply shortages, prompting reliance on multiple suppliers to mitigate risks.
Emerging Trends
- Vertical Integration: Major pharmaceutical companies are increasingly integrating API manufacturing with final product development to control quality and supply.
- Regulatory Harmonization: Efforts to align international regulations aim to streamline approvals and facilitate broader distribution.
- Technology Advancements: Improvements in synthetic pathways, such as bio-engineering methods, aim to increase efficiency, reduce costs, and enhance purity.
- Regional Market Growth: Asia-Pacific, especially China and India, continues to expand its API manufacturing footprint, offering cost advantages and increased capacity.
Conclusion
The supply landscape for buprenorphine hydrochloride is characterized by a limited but globally distributed array of reputable suppliers. Leading brands like Indivior, Böhringer Ingelheim, Hikma, Zhejiang Gensci, and Respect Pharmaceuticals dominate manufacturing, supported by a network of CMOs that ensure flexible, high-volume production. Regulatory compliance, quality assurance, raw material access, and geopolitical stability are critical factors influencing supply reliability.
As global demand for opioid dependence treatments and pain management options intensifies, continuous diversification of suppliers, investments in manufacturing capacity, and adherence to regulatory standards will be pivotal for stakeholders aiming to ensure secure procurement and uninterrupted supply.
Key Takeaways
- Major Suppliers: Indivior, Böhringer Ingelheim, Hikma, Zhejiang Gensci, and Respect Pharmaceuticals are the primary sources of buprenorphine hydrochloride globally.
- Regulatory Compliance: Suppliers must meet rigorous GMP and controlled substance regulations to ensure legal and safe distribution.
- Geographic Spread: Asia-Pacific, Europe, and North America lead in manufacturing, with emerging players in China and India providing cost-effective options.
- Supply Chain Risks: Regulatory hurdles, geopolitical issues, raw material dependence, and capacity limitations pose ongoing challenges.
- Future Outlook: Technological innovations and regional capacity expansion, especially in Asia, will shape the supply landscape.
FAQs
1. What are the main regions producing buprenorphine hydrochloride?
The dominant producing regions include Europe (Germany, UK), North America (US), and Asia (China, India), driven by advanced manufacturing facilities and raw material access.
2. How do regulatory agencies impact the supply of buprenorphine hydrochloride?
Strict regulations governing controlled substances require suppliers to obtain comprehensive licenses, adhere to GMP standards, and undergo regular inspections, influencing supply stability.
3. Are generic suppliers reliable for consistent supply?
Yes, established generic manufacturers in India and China have demonstrated consistent quality and capacity, but due diligence regarding regulatory compliance remains essential.
4. Can I directly source buprenorphine hydrochloride from chemical manufacturers?
Typically, only licensed pharmaceutical entities can purchase APIs due to control regulations; end-users must have appropriate licenses and certifications.
5. What trends could disrupt future buprenorphine hydrochloride supply chains?
Potential disruptions include tightening regulations, raw material shortages (e.g., thebaine), geopolitical tensions, and large-scale manufacturing capacity constraints.
References
[1] U.S. Food and Drug Administration (FDA). "Controlled Substance Highlights."
[2] European Medicines Agency (EMA). "Manufacturing and Quality Standards."
[3] IMS Health. Global API Market Analysis, 2022.
[4] IQVIA Institute. "The Future of Opioid Use and Management," 2021.
[5] National Pharmaceutical Regulatory Bodies in China and India. Industry Reports, 2022.
More… ↓
