Suppliers and packagers for nardil

nardil

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

Suppliers for the Pharmaceutical Drug: NARDIL

Last updated: July 28, 2025

Introduction

NARDIL (phenelzine sulfate) is a historically significant medication used primarily for the treatment of major depressive disorder and certain atypical depression cases. As a monoamine oxidase inhibitor (MAOI), NARDIL demands high-quality manufacturing standards due to its pharmacological potency and safety profile. Identifying credible suppliers of NARDIL involves understanding the drug's manufacturing landscape, regulatory environment, and global distribution channels.

This comprehensive analysis explores the key suppliers of phenelzine sulfate, the active pharmaceutical ingredient (API) and finished formulations, across different regions. It aids pharmaceutical companies, healthcare providers, and investors in understanding the supply chain dynamics and market positioning of NARDIL.

Manufacturers of NARDIL API: Phenelzine Sulfate

Global API Producers

Historically, phenelzine sulfate was produced by major pharmaceutical companies with expertise in MAOI compounds. Although its market remains niche, several API manufacturers still offer phenelzine sulfate for research and institutional use:

• Aspen Pharmacare (South Africa): Known for producing a variety of APIs, Aspen has historically supplied phenelzine sulfate for both branded and generic applications. Their manufacturing compliance adheres to international GMP standards, positioning them as a reliable supplier in emerging markets.

• Hainan Bao Jin Pharmaceutical Co., Ltd. (China): Specializes in synthesizing psychiatric APIs, including phenelzine sulfate, for domestic and export markets. Their production complies with Chinese GMP regulations and is increasingly recognized internationally.

• Teva Pharmaceutical Industries Ltd. (Israel): While Teva's focus is predominantly on generic pharmaceuticals, they have historically produced a range of psychiatric APIs. Their involvement with phenelzine sulfate has been limited but remains a potential source through licensed manufacturing agreements.

• Sichuan Hisoar Pharmaceutical Co., Ltd. (China): Another Chinese API manufacturer with capabilities in phenelzine sulfate synthesis, catering mainly to Asia and partially to international markets.

Contract Manufacturing Organizations (CMOs)

In recent years, the complexity of pharmaceutical manufacturing has led to the proliferation of CMOs that offer custom synthesis of phenelzine sulfate under strict confidentiality agreements:

• Lonza Group (Switzerland): Although primarily focused on biologics, Lonza offers small molecule API synthesis, including nichepsychiatric compounds like phenelzine sulfate, via contract services.

• BASF SE (Germany): As a global chemical leader, BASF provides custom synthesis of active pharmaceutical ingredients, including MAOIs, under rigorous GMP standards.

• Suven Life Sciences (India): An established CMO producing specialty APIs, Suven offers phenelzine sulfate as part of their psychiatric API portfolio.

Market Entry and Regulatory Considerations

Suppliers exporting phenelzine sulfate must navigate strict regulatory frameworks, particularly for APIs intended for human consumption. Import jurisdictions like the US (via FDA), Europe (EMA), and Japan enforce rigorous GMP standards.

For companies seeking API supply, it’s critical to verify:

• GMP certification compliance
• Regulatory approvals and registration statuses
• Traceability and supply chain transparency

Finished Pharmaceutical Manufacturers of NARDIL

While Pfizer was originally responsible for NARDIL's production, the commercial availability of NARDIL has diminished, with some markets discontinuing its sale. Nonetheless, certain regional pharmaceutical companies and compounding pharmacies may produce finished NARDIL formulations:

• Kyorin Pharmaceutical Co. Ltd. (Japan): Historically marketed NARDIL in Japan, with ongoing production under local licensing agreements.

• Generic Manufacturers in India: Some pharmaceutical firms produce phenelzine sulfate capsules, often branded as generics equivalent to NARDIL, primarily for the domestic Indian market.

• Compounding Pharmacies: In regions where NARDIL is discontinued, specialized compounding pharmacies may prepare phenelzine sulfate formulations under strict regulatory controls.

Distribution and Market Dynamics

The decline in NARDIL’s global market share is attributed to concerns over its side effect profile and the advent of newer antidepressants (SSRIs, SNRIs). Consequently, supply chains are somewhat niche-dependent. Suppliers in Asia and emerging markets continue to distribute phenelzine sulfate API and formulations, primarily for research and specialized use.

Market resilience depends on ongoing clinical research, regulatory approvals, and the drug's niche applications. Suppliers with GMP-certified manufacturing facilities and robust supply chains have a competitive edge.

Regulatory and Patent Landscape

Most jurisdictions have long since expired patents on phenelzine sulfate, facilitating generic manufacturing. However, regulatory approvals and market authorizations heavily influence supply dynamics. The absence of new patents further encourages manufacturers to produce phenelzine sulfate for research purposes, rather than mass-market antidepressants.

Emerging Trends in Supply Chain

• Shift towards Asian manufacturers: China's pharmaceutical industry increasingly dominates niche API production, including phenelzine sulfate, driven by cost competitiveness and regulatory reforms.

• Quality assurance emphasis: The critical nature of psychotropic APIs demands adherence to international GMP standards, influencing procurement decisions.

• Research and off-label applications: Ongoing research into MAOIs sustains demand for phenelzine sulfate API, primarily from research institutions and specialized compounding facilities.

Conclusion

The supply chain for NARDIL, primarily through phenelzine sulfate API, is characterized by regional specialization. While major pharmaceutical companies have scaled back production, Chinese and Indian manufacturers maintain a foothold in niche markets. Regulatory barriers and the drug’s declining market share restrict widespread distribution, but high-quality API suppliers remain active for research and specialized indications.

Key Takeaways

• NARDIL’s primary API suppliers are based in China, India, and Europe, with regional variations in manufacturing standards.

• Strict adherence to GMP standards is critical for API suppliers, especially for psychotropic compounds like phenelzine sulfate.

• Market decline has led to a focus on research and compounding production rather than mass-market formulations.

• Emerging Asian manufacturers are increasingly dominant in the phenelzine sulfate supply chain, offering cost-effective options.

• Regulatory clearance remains a barrier for new entrants but provides opportunities for established manufacturers with compliant APIs.

FAQs

1. Are there synthetic alternatives to phenelzine sulfate for depression treatment?
Yes. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have largely replaced MAOIs like phenelzine sulfate due to improved safety profiles and fewer dietary restrictions.

2. Can I source phenelzine sulfate directly from manufacturers for clinical or research purposes?
Yes. Several Chinese and Indian API suppliers offer phenelzine sulfate for research use, typically under strict regulatory compliance. Commercially available finished formulations are limited.

3. Is NARDIL still approved for use in the United States?
No. The original brand NARDIL was discontinued in the US; however, phenelzine sulfate remains available as a generic for research and compounded formulations under applicable regulations.

4. How do regulatory standards impact the global supply chain of phenelzine sulfate?
Manufacturers must comply with GMP standards set by local authorities (such as FDA or EMA). Regulatory approvals ensure manufacturing quality, affecting the availability and international trade of phenelzine sulfate.

5. What market sectors primarily drive demand for phenelzine sulfate today?
Research institutions, specialized psychiatric clinics, and compounding pharmacies are the main sectors maintaining demand, with limited use in broader clinical applications.

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Sources:
[1] U.S. Food and Drug Administration. "Drug Approvals and Databases." FDA, 2023.
[2] Market Research Future. "Global API Market Analysis," 2022.
[3] Chinese Pharmacopoeia. "Standards for Phenelzine Sulfate," 2021.
[4] Indian Pharmacopoeia. "API Manufacturing Guidelines," 2022.
[5] European Medicines Agency. "Regulatory Frameworks for APIs," 2023.