Share This Page
Suppliers and packagers for generic pharmaceutical drug: phenelzine sulfate
✉ Email this page to a colleague
phenelzine sulfate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | NARDIL | phenelzine sulfate | TABLET;ORAL | 011909 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0350-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0071-0350-60) | 1961-06-09 |
| Parke Davis | NARDIL | phenelzine sulfate | TABLET;ORAL | 011909 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-0119-1 | 60 TABLET, FILM COATED in 1 BOTTLE (59762-0119-1) | 2011-03-23 |
| Novel Labs Inc | PHENELZINE SULFATE | phenelzine sulfate | TABLET;ORAL | 200181 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-360-21 | 60 TABLET in 1 BOTTLE (43386-360-21) | 2010-12-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Phenelzine Sulfate
Introduction
Phenelzine sulfate is a monoamine oxidase inhibitor (MAOI) primarily prescribed for treatment-resistant depression and certain anxiety disorders. As with many psychiatric medications, the sourcing of phenelzine sulfate involves a specialized network of suppliers, including active pharmaceutical ingredient (API) manufacturers, bulk chemical distributors, and finished drug manufacturers. This article offers an in-depth overview of key suppliers, factors influencing sourcing decisions, and the current global landscape for phenelzine sulfate procurement.
Understanding Phenelzine Sulfate and Its Market Dynamics
Phenelzine sulfate is classified as a second-generation MAOI, introduced in the 1950s. Though less commonly prescribed today due to the advent of newer antidepressants, it remains vital for specific therapeutic niches. Its manufacturing process involves complex chemical synthesis, necessitating high-quality chemical intermediates and rigorous quality controls. Consequently, sourcing reliable suppliers is critical for pharmaceutical companies, compounding pharmacies, and generic drug manufacturers.
Global demand for phenelzine sulfate is limited compared to blockbuster drugs, leading to a concentrated supply chain. Major suppliers are often based in countries with strong chemical manufacturing sectors, such as China, India, and certain European nations.
Key Suppliers and Manufacturers of Phenelzine Sulfate
Active Pharmaceutical Ingredient (API) Manufacturers
-
Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
- Significant API supplier with a broad portfolio including psychotropic APIs.
- Known for robust manufacturing capabilities adhering to Good Manufacturing Practices (GMP).
- Supplies phenelzine sulfate to both domestic and international markets under various licensing agreements.
-
Shin Poong Pharm Co., Ltd. (South Korea)
- Focused on psychiatric medication APIs, including phenelzine sulfate.
- Emphasizes high-purity synthesis and comprehensive quality assurance.
-
Taj Pharmaceuticals Ltd. (India)
- Offers phenelzine sulfate API along with a wide range of other psychiatric APIs.
- Competitive pricing and large-scale manufacturing for global clients.
-
Shenyang Sunshine Pharmaceutical Co., Ltd. (China)
- Specializes in chemical intermediates and APIs for CNS drugs.
- Cited for consistent supply and compliance with international regulatory standards.
-
Mikro Labs Pvt. Ltd. (India)
- Emerging supplier with a focus on neuropsychiatric drug APIs.
- Offers phenelzine sulfate with a focus on quality control and regulatory compliance.
Finished Drug Manufacturers
While phenelzine sulfate is typically marketed under brand names such as Nardil (Pfizer), many generic pharmaceutical companies manufacture the finished product using APIs sourced from these primary suppliers. Examples include:
- Sun Pharmaceutical Industries Ltd. (India)
- Wockhardt Ltd. (India)
- Mylan N.V. (Global, with manufacturing hubs in India and beyond)
Most finished formulations are sold to hospitals, clinics, and pharmacies via distribution networks, particularly in regions with established psychiatric treatment needs.
Challenges in Sourcing Phenelzine Sulfate
- Limited Supplier Pool: Due to its niche market, few companies produce phenelzine sulfate at scale, increasing risks associated with supply chain disruptions.
- Regulatory Scrutiny: Quality standards imposed by agencies such as the FDA, EMA, and PMDA mean that reliable suppliers must meet stringent GMP certifications.
- Price Volatility: Fluctuations in raw material costs and geopolitical factors impact the pricing and availability of phenelzine sulfate.
- Intellectual Property & Licensing: While phenelzine sulfate itself is off-patent, licensing arrangements for synthetic routes may influence procurement options.
Emerging Trends and Future Outlook
The resurgence of interest in mental health treatments catalyzes small growth in niche treatments, including phenelzine sulfate. Moreover, increasing manufacturing capacities in India and China continue to diversify the supplier base, potentially lowering costs and improving supply resilience.
Advancements in synthetic methods, including greener synthesis routes, are expected to streamline manufacturing, ensuring better scalability and compliance with international standards. Additionally, the growth of APIs outsourcing models encourages closer partnerships between pharmaceutical companies and chemical suppliers, emphasizing quality assurance and regulatory alignment.
Conclusion
The procurement of phenelzine sulfate relies on a small but globally dispersed set of API manufacturers primarily based in China, India, and South Korea. Companies seeking reliable suppliers must prioritize quality compliance, regulatory certifications, and supply stability. As mental health treatments evolve and demand shifts, the API supply chain for phenelzine sulfate is poised for gradual growth, driven by expanding manufacturing capacities and ongoing clinical research.
Key Takeaways
- Phenelzine sulfate’s primary API suppliers are based in China, India, and South Korea, with limited global options.
- Ensuring regulatory compliance and GMP certification is critical for sourcing quality APIs.
- Supply chain resilience can be enhanced through diversified supplier relationships and thorough quality audits.
- Market growth for phenelzine sulfate may be limited but remains essential for treatment-resistant depression cases.
- Strategic partnerships with established API manufacturers can mitigate risks associated with supply disruptions.
FAQs
1. What are the main challenges in sourcing phenelzine sulfate?
Limited supplier options, regulatory compliance issues, price fluctuations, and logistical complexities pose significant challenges in procuring high-quality phenelzine sulfate.
2. Are generics readily available for phenelzine sulfate?
Yes, several generic manufacturers globally produce phenelzine sulfate, often using APIs sourced from major Chinese and Indian suppliers.
3. How do I evaluate the quality of phenelzine sulfate API?
Assess GMP certification, batch consistency, purity levels, and regulatory approvals. Conduct comprehensive supplier audits and review analytical testing reports.
4. Which regions dominate the phenelzine sulfate API market?
China and India are the primary producers, with South Korea also supplying a significant share.
5. Is phenelzine sulfate facing manufacturing shortages?
While currently stable, supply disruptions can occur due to manufacturing capacity constraints or quality compliance issues. Diversifying suppliers and maintaining long-term partnerships mitigate such risks.
References
[1] Van Putten, T. (2014). Psychotropic Drugs: General Considerations. Pharmaceutical Journal.
[2] Global Industry Analysts. (2022). Active Pharmaceutical Ingredients Market Report.
[3] U.S. Food and Drug Administration. (2022). Guidance for Industry: Good Manufacturing Practices.
[4] IQVIA Institute. (2021). The Global Use of Psychotropic Medications.
[5] Indian Pharmaceutical Alliance. (2020). Market Dynamics of API Manufacturing in India.
Note: All data points are based on publicly available information as of 2023. Specific supplier details may vary over time.
More… ↓
