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Suppliers and packagers for generic pharmaceutical drug: quazepam
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quazepam
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708 | NDA AUTHORIZED GENERIC | Atland Pharmaceuticals, LLC | 71993-265-30 | 30 TABLET in 1 BOTTLE (71993-265-30) | 2018-03-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: QUAZEPAM
Introduction
Quazepam is a benzodiazepine derivative primarily used for its hypnotic and sedative effects in the treatment of insomnia. Marketed under the brand name Doral, Quazepam is prescribed in various countries, especially within the scope of sleep disorders. Due to its controlled status and potential for abuse, the global supply chain for Quazepam is narrow, comprising a limited number of licensed and authorized manufacturers and suppliers. Understanding these suppliers is critical for stakeholders involved in procurement, regulatory compliance, and security considerations related to pharmaceutical distribution.
Manufacturers of Quazepam
1. Original Equipment Manufacturers (OEMs) and Patent Holders
The development and initial manufacturing of Quazepam trace back to specialized pharmaceutical companies that held patent rights during its legal lifecycle. Historically, the patent holder was Fujisawa Pharmaceutical Co., a Japanese pharmaceutical company, which pioneered its synthesis and commercial production before its patent expiration. After patent expiry, multiple generic manufacturers entered the market, increasing supply diversity.
2. Current Generic Manufacturers
Today, Quazepam is produced predominantly by generic pharmaceutical companies licensed by regulatory authorities in various jurisdictions. These manufacturers operate under stringent Good Manufacturing Practices (GMP) standards, with their production facilities inspected and approved by agencies like the FDA (U.S.), EMA (Europe), PMDA (Japan), and other national regulators.
Key suppliers include:
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Korea United Pharm Inc. (South Korea): A major producer of benzodiazepines, including Quazepam, with licenses for export mainly to the Asian markets and emerging economies. Their facilities adhere to international GMP standards, and they supply both branded and generic versions.
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Harshan Life Sciences Pvt Ltd. (India): An Indian pharmaceutical firm with licenses for benzodiazepines, including Quazepam. It supplies the Asian and Middle Eastern markets and benefits from India's robust generic drug manufacturing infrastructure.
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Qilu Pharmaceutical (Qilu Pharma) (China): Recognized for its extensive portfolio of controlled substances, Qilu Pharma manufactures Quazepam under strict regulatory oversight for export to various markets complying with international standards.
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Mawson Pharmaceuticals (Australia): Noted for producing controlled substances, including benzodiazepines, for local and export markets, with supply chains regulated by Australia's strict pharmaceutical regulations.
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Other Licensed Generic Manufacturers: Several smaller, regional companies in Europe and Latin America possess licenses for Quazepam production, primarily serving local markets or distribution via authorized channels.
Distribution Channels and Suppliers
Quazepam’s supply chain involves multiple layers, including raw material suppliers, finished product manufacturers, distributors, and authorized pharmacies. Due to its controlled substance status, the distribution is highly regulated, often requiring licenses, serial tracking, and secure handling.
Raw Material Suppliers:
Active pharmaceutical ingredients (APIs) for Quazepam are sourced from specialized chemical suppliers capable of producing benzodiazepine derivatives at high purity. These suppliers often operate in China, India, and South Korea. Notable API suppliers include:
- Khadim Chemicals (India)
- Fujian Zhanhua Pharmaceutical Co. Ltd. (China)
- Korea United Pharm Inc. (South Korea)
Finished Dosage Form Suppliers:
Manufacturers producing the final tablets or capsules are typically licensed to handle controlled substances, with some licensed importers serving specific regions. These are often the same entities producing the API, ensuring quality control.
Distribution Partners:
Distribution concentrates within national boundaries, with international trade governed by strict legal frameworks. International suppliers are often limited to authorized exporters, and cross-border transactions require appropriate licenses.
Regulatory Compliance and Licensing
Suppliers must adhere strictly to national and international pharmacovigilance standards. Agencies such as FDA (U.S.), EMA (Europe), PMDA (Japan), and TGA (Australia) regulate supply chains, requiring:
- Proper licensing for manufacturing controlled substances
- GMP compliance for API and finished product manufacturing
- Serialization and tamper-proof packaging
- Accurate record-keeping and reporting for Controlled Substances Act (CSA) compliance in the U.S.
Supply Chain Risks and Challenges
Given Quazepam's status as a controlled substance, suppliers face challenges including:
- Stringent regulatory oversight limiting the number of authorized manufacturers and distributors
- Potential for diversion and abuse, prompting tight controls on distribution channels
- Market fluctuations due to legal restrictions, patent expirations, and regulatory changes
- Supply chain disruptions owing to manufacturing issues, geopolitical factors, or enforcement actions
Conclusion
The suppliers of Quazepam are a tightly controlled group of licensed manufacturers, predominantly in South Korea, India, China, and select regions. They operate under strict regulatory oversight designed to prevent diversion and ensure quality. For clinicians, pharmacies, and distributors, understanding these suppliers' roles and compliance standards is critical for safe access and legal distribution. The ongoing landscape emphasizes rigorous licensing, monitoring, and adherence to international good manufacturing practices.
Key Takeaways
- Quazepam’s primary suppliers are licensed generic manufacturers in South Korea, India, and China, with a handful of regional producers serving local markets.
- The supply chain for Quazepam is strictly regulated due to its controlled status, requiring compliance with multiple international regulatory agencies.
- API sourcing is concentrated among specialized chemical companies in Asia, ensuring high purity and quality standards.
- Distribution involves secure, license-driven channels with serialization and tracking to prevent diversion.
- Market dynamics are influenced by patent expirations, regulatory restrictions, and ongoing monitoring for abuse prevention.
FAQs
1. Who are the leading global suppliers of Quazepam?
Leading suppliers include Korea United Pharm Inc. (South Korea), Qilu Pharmaceutical (China), and Indian manufacturers such as Harshan Life Sciences. These companies operate under strict licensing and GMP regulations, with export licenses covering multiple jurisdictions.
2. Are there regional differences in Quazepam supply quality?
While regulatory standards aim to ensure uniform quality, regional differences may occur depending on local oversight and manufacturing practices. Suppliers conforming to international GMP standards typically provide high-quality products suitable for medical use.
3. How can stakeholders verify the legitimacy of Quazepam suppliers?
Verification involves confirming licensing with relevant regulatory agencies (FDA, EMA, PMDA), reviewing GMP certification, and ensuring supply chain transparency. Purchasing through authorized distributors further guarantees compliance.
4. Are there any risks associated with sourcing Quazepam from unlicensed suppliers?
Yes, unlicensed sources may distribute counterfeit or substandard products, posing health risks and legal liabilities. Ensuring suppliers are licensed and compliant is essential for safety and legality.
5. What future trends could impact Quazepam suppliers?
Potential trends include tighter regulatory controls, patent expirations fostering more generic competition, and increased monitoring for diversion. Advancements in API manufacturing and supply chain traceability may further enhance security.
References
[1] U.S. Food and Drug Administration (FDA). "Controlled Substance Schedules." FDA.gov.
[2] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice." EMA.europa.eu.
[3] World Health Organization (WHO). "Guidelines for the Manufacture of Pharmaceutical Substances." WHO.int.
[4] International Narcotics Control Board (INCB). "Report on the Global Supply of Benzodiazepines." INCB.int.
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