Share This Page
Suppliers and packagers for klonopin
✉ Email this page to a colleague
klonopin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-605-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10) | 1975-06-02 |
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-610-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10) | 1975-06-02 |
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-620-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10) | 1975-06-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: KLONOPIN
Introduction
KLONOPIN, the brand name for clonazepam, is a widely prescribed benzodiazepine used primarily for treating epilepsy, panic disorders, and anxiety. As a controlled substance with significant regulatory oversight, the supply chain of KLONOPIN is complex, involving multiple stakeholders including active pharmaceutical ingredient (API) manufacturers, formulation companies, wholesalers, and regulatory authorities. Ensuring a stable, compliant, and quality-assured supply chain is essential for healthcare providers and patients relying on this medication. This article provides a comprehensive overview of the key suppliers involved in the supply of KLONOPIN, highlighting manufacturing sources, distribution channels, and the geopolitical landscape influencing its availability.
Manufacturing of Active Pharmaceutical Ingredient (API)
Major API Manufacturers
The foundation of KLONOPIN supply hinges on the production of high-quality clonazepam API. Several pharmaceutical companies globally have the capacity to manufacture clonazepam API, many of which are highly regulated due to the drug’s classification as a controlled substance (Schedule IV in the US, Schedule IV in the EU).
-
Teva Pharmaceuticals
Based in Israel, Teva is one of the largest generic pharmaceutical manufacturers worldwide, with extensive operations in API production. Teva’s clonazepam API is widely used across various generic formulations. -
Mylan (now part of Viatris)
A significant player, Mylan has established facilities in India, Europe, and the United States capable of producing clonazepam API, ensuring diversified supply sources. -
Sandoz (a Novartis division)
Sandoz possesses European API manufacturing capabilities, with a focus on high-quality generic APIs, including clonazepam, adhering to strict regulatory standards. -
Empowered by Chinese API Suppliers
Several Chinese API producers also supply clonazepam to the international market. These include companies like Zhejiang Hisun Pharmaceutical Co., Ltd. and North China Pharmaceutical Group Corporation, which manufacture APIs compliant with international standards.
Regulatory and Quality Considerations
API manufacturers are subject to regulatory standards such as the US Drug Master File (DMF), European Medicines Agency (EMA) certification, and Good Manufacturing Practice (GMP) compliance. The regulatory landscape influences supplier availability, with strict oversight potentially limiting API producers to those with robust compliance records.
Formulation and Final Dosage Production
Following API manufacturing, pharmaceutical companies engage in formulation, which involves converting the API into dosage forms such as tablets or oral solutions.
Key Formulation Companies
-
Pfizer (formerly Lilly)
Initially developed and commercialized KLONOPIN, Pfizer remains a legacy supplier for specific formulations in select markets. -
Teva Pharmaceuticals
Alongside API manufacturing, Teva produces finished KLONOPIN tablets, supplied globally under their brand or as generics. -
Mylan/Viatris
Offers various formulations, focusing on cost-effective generics distributed worldwide. -
Sandoz and other generics manufacturers
Focus on producing competitively priced clonazepam formulations that meet regional regulatory requirements.
Distribution and Supply Chain Dynamics
Global Supply Channels
Distribution involves a network of wholesalers, specialty pharmacies, and healthcare providers. The tight regulation of controlled substances introduces barriers such as license requirements, import/export restrictions, and surveillance by regulatory bodies like the DEA (US Drug Enforcement Administration) and EMA.
Geopolitical and Regulatory Impacts
-
United States and Europe: Stringent controls limit the number of authorized suppliers, primarily domestic and established international firms with robust compliance protocols.
-
India and China: Serve as significant sources of both API and formulation components due to cost efficiencies and manufacturing scale. However, supply stability depends on regulatory adherence and geopolitical considerations.
Supply Chain Risks
- Disruption in API production, regulatory non-compliance, or geopolitical tensions can impact supply chain stability. In recent years, the COVID-19 pandemic highlighted vulnerabilities, prompting calls for diversification and strategic stockpiling.
Key Suppliers Overview
| Supplier | Location | Role | Regulatory Status | Noteworthy Attributes |
|---|---|---|---|---|
| Teva Pharmaceuticals | Israel | API & finished product | GMP-certified | Largest generic clonazepam producer worldwide |
| Mylan / Viatris | USA / India | API & formulations | GMP & FDA-approved | Diversified global supply chain |
| Sandoz | Switzerland | API & formulations | EMA & GMP compliance | European market focus |
| Zhejiang Hisun Pharmaceutical | China | API | WHO-GMP, ISO certified | Cost-effective API solutions |
| North China Pharmaceutical Group | China | API | GMP | Major regional API supplier |
Regulatory and Ethical Considerations
The controlled status of KLONOPIN demands strict adherence to legal and regulatory frameworks OEM's and distributors must comply with:
- Import/export licensing
- Distribution documentation
- Audit and quality assurance processes
- Counterfeit prevention initiatives
Suppliers must maintain transparency and traceability throughout the supply chain to mitigate risks associated with diversion or illicit manufacturing.
Conclusion
KLONOPIN’s supply chain relies on a diverse array of global suppliers, primarily in North America, Europe, and Asia. API manufacturers like Teva, Mylan, and Sandoz dominate the landscape, supported by formulation and distribution networks that are highly regulated. While international manufacturing enhances supply resilience, regulatory compliance, geopolitical factors, and quality assurance remain critical determinants of supply stability. Stakeholders must monitor these variables closely to ensure uninterrupted access to safe and effective clonazepam therapies.
Key Takeaways
- Major API producers include Teva, Mylan, Sandoz, and Chinese suppliers, all regulated under GMP standards.
- Formulation and distribution are predominantly managed by established multinational pharmaceutical companies, ensuring consistent product quality.
- Supply chain vulnerabilities include geopolitical tensions, regulatory non-compliance, and global disruptions like COVID-19.
- Regulatory oversight in major markets ensures quality but limits the pool of authorized suppliers, influencing pricing and availability.
- Strategic diversification and compliance are vital for stakeholders to maintain a stable supply of KLONOPIN globally.
FAQs
1. Who are the primary global suppliers of KLONOPIN API?
Major API producers include Teva Pharmaceuticals, Mylan (Viatris), and Sandoz, alongside Chinese manufacturers like Zhejiang Hisun Pharmaceutical, all operating under strict GMP and regulatory standards.
2. Are there regional differences in KLONOPIN supply?
Yes. In North America and Europe, supply is concentrated among a few regulated manufacturers, while in Asia, Chinese and Indian API producers supplement global supplies, often at lower costs but with varying quality considerations.
3. How do regulatory agencies influence KLONOPIN supply?
Regulatory agencies such as the FDA and EMA enforce GMP compliance, requiring manufacturer transparency, which limits the pool of qualified suppliers and impacts global availability.
4. What risks threaten the stability of KLONOPIN supply?
Risks include manufacturing disruptions, regulatory restrictions, geopolitical tensions, and global crises like pandemics, which can cause shortages or delays.
5. How can pharmaceutical companies mitigate supply chain risks for KLONOPIN?
Diversifying suppliers across regions, maintaining strategic stockpiles, adhering strictly to regulatory standards, and implementing robust supply chain oversight are key strategies.
Sources
[1] U.S. Food and Drug Administration (FDA). Drug Master Files.
[2] European Medicines Agency (EMA). Quality Guidelines.
[3] Teva Pharmaceuticals Annual Report 2022.
[4] Mylan/Viatris Global API Capabilities.
[5] Chinese API Manufacturers: Zhejiang Hisun Pharmaceutical Co., Ltd. and North China Pharmaceutical Group Corporation Reports.
More… ↓
