Suppliers and packagers for generic pharmaceutical drug: PHENELZINE SULFATE

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
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
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	Greenstone LLC	59762-0119-1	60 TABLET, FILM COATED in 1 BOTTLE (59762-0119-1)	2011-03-23

Phenelzine Sulfate Suppliers: Manufacturing Landscape and Global Supply Chain Dynamics

Phenelzine sulfate, a monoamine oxidase inhibitor (MAOI) used primarily in treating major depressive disorder, has a complex global supply chain involving specialized manufacturers and distributors. This analysis examines the key suppliers, regulatory frameworks, and market dynamics shaping its availability, drawing on recent data from pharmaceutical databases and regulatory announcements.

Regulatory Framework and Manufacturing Standards

Phenelzine sulfate manufacturers must comply with stringent regulatory requirements, including Good Manufacturing Practices (GMP) and region-specific certifications such as U.S. Drug Master Files (USDMF), Certificates of Suitability (CEP), and Japanese Drug Master Files (JDMF)[1][2][9]. These certifications ensure adherence to quality standards and facilitate international trade. For instance, companies like Procos S.p.A. (Italy) and Siegfried AG (Germany) maintain USDMF and CEP approvals, enabling them to supply active pharmaceutical ingredients (APIs) to markets in the U.S., Europe, and Japan[1][5][9].

The FDA mandates that manufacturers provide detailed documentation, including chemical properties, manufacturing processes, and packaging details, in confidential USDMF submissions[2][4]. Similarly, the European Medicines Agency requires CEP certifications to verify compliance with pharmacopeial standards[2][9]. These regulatory hurdles limit the number of qualified suppliers, creating a concentrated market dominated by established players.

Key Global Manufacturers and Suppliers

1. European Suppliers: Procos and Siegfried AG

Procos S.p.A., a subsidiary of Japan’s CBC Group, specializes in niche APIs, including phenelzine sulfate. The company’s Italian facilities are GMP-certified and supply APIs to global markets under USDMF and CEP approvals[5][9]. Siegfried AG, based in Switzerland, offers tailored manufacturing services and holds certifications for U.S. and European markets, making it a critical supplier for branded and generic formulations[1][5][12]. Both companies emphasize small-batch production, catering to the low-volume demand for MAOIs.

2. Indian Manufacturers: Lupin Pharmaceuticals and Tyche Industries

Lupin Pharmaceuticals has emerged as a pivotal supplier during recent shortages. In 2020, Lupin’s phenelzine sulfate tablets were authorized under Australia’s Section 19A and New Zealand’s Section 29 provisions after the discontinuation of Pfizer’s Nardil[6][10][11]. Lupin’s formulations, produced in GMP-compliant facilities, include excipients like croscarmellose sodium and magnesium stearate[3][11]. Tyche Industries Ltd, another Indian supplier, holds USDMF and WHO-GMP certifications, focusing on cost-effective API production[1][7].

3. U.S. and Multinational Suppliers: Greenstone and Novel Laboratories

Greenstone LLC (a Pfizer subsidiary) and Novel Laboratories supply phenelzine sulfate tablets in the U.S. Greenstone’s product (NDC 59762-0119-01) remains available despite Pfizer’s Nardil facing manufacturing delays[11]. Novel Laboratories’ formulation (NDC 40032-360) uses excipients such as polyethylene glycol and titanium dioxide, complying with USP standards[3][11]. Both companies highlight the role of strategic stockpiling and diversified sourcing in mitigating supply chain disruptions.

Regional Supply Chain Challenges

Australia and New Zealand: Transition to Lupin

The 2020 discontinuation of Pfizer’s Nardil in Australia prompted the Therapeutic Goods Administration (TGA) to approve Lupin’s phenelzine sulfate under Section 19A, with Barwon Pharma and Generic Health distributing the product[6][10]. Similarly, New Zealand’s Pharmac authorized Lupin’s tablets under Section 29 to address shortages, though supply remains limited[10]. These transitions underscore the fragility of MAOI supply chains and the reliance on alternative suppliers during crises.

U.S. Market: Intermittent Shortages

The American Society of Health-System Pharmacists (ASHP) reports periodic shortages of phenelzine sulfate tablets, attributed to manufacturing delays at Pfizer and increased demand for generics[11]. Lupin (NDC 43386-0360-21) and Greenstone have filled gaps, but their reliance on offshore API production—primarily from India and Europe—introduces vulnerabilities tied to geopolitical and logistical factors[11][12].

Quality Assurance and Excipient Profiles

Phenelzine sulfate formulations vary by supplier, with excipients like mannitol, talc, and edetate disodium ensuring stability and bioavailability[3]. For example:

• Lupin’s tablets contain FD&C Yellow No. 6 and silicon dioxide[3].
• Greenstone’s product uses isopropyl alcohol and polyvinyl alcohol in its coating[3].

Certificates of Analysis (CoA) provided by suppliers like Procos and Siegfried AG verify batch-specific compliance with pharmacopeial standards, such as USP and EP[2][8]. These documents are critical for hospital procurement teams assessing product quality during supplier transitions.

Conclusion

The phenelzine sulfate supply chain is characterized by a limited number of GMP-certified manufacturers, regional regulatory dependencies, and ongoing susceptibility to disruptions. Suppliers like Lupin, Procos, and Siegfried AG play vital roles in maintaining global access, particularly during shortages. Healthcare providers must prioritize partnerships with suppliers offering robust quality assurance protocols and diversified manufacturing networks to ensure patient access to this critical antidepressant.

“The fragility of the phenelzine supply chain highlights the need for diversified manufacturing and proactive regulatory collaboration.” — Therapeutic Goods Administration (TGA)[6]

Key Takeaways

• Procos and Siegfried AG dominate European API production with USDMF/CEP certifications.
• Lupin Pharmaceuticals is a key emergency supplier in Australia and New Zealand.
• U.S. availability relies on Greenstone and Lupin, though shortages persist.
• Excipient profiles and CoAs are critical for evaluating supplier reliability.

FAQs

1. Which companies supply phenelzine sulfate to the U.S.?
   Greenstone (Pfizer), Lupin, and Novel Laboratories are active suppliers[11].
2. Why did Australia approve Lupin’s phenelzine sulfate?
   To address shortages after Pfizer discontinued Nardil in 2020[6][10].
3. What certifications are required for phenelzine sulfate manufacturers?
   GMP, USDMF, and CEP are essential for U.S. and European markets[1][2][9].
4. How do excipients vary between suppliers?
   Lupin uses FD&C Yellow No. 6, while Greenstone employs isopropyl alcohol[3][11].
5. What caused recent U.S. shortages?
   Manufacturing delays at Pfizer and increased generic demand[11].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/phenelzine-sulfate
2. https://www.pharmacompass.com/active-pharmaceutical-ingredients/phenelzine-sulfate
3. https://www.drugpatentwatch.com/p/excipients/api/phenelzine+sulfate
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/nardil
5. https://pharmaoffer.com/api-excipient-supplier/mao-inhibitors/phenelzinum
6. https://www.tga.gov.au/safety/shortages/medicine-shortage-alerts/phenelzine-nardil
7. https://www.chemicalbook.com/Manufacturers/phenelzine-sulfate.htm
8. https://pharmaoffer.com/api-excipient-supplier/mao-inhibitors/phenelzine/coa-dmf
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/phenelzine
10. https://pharmac.govt.nz/assets/2020-Communications-regarding-phenelzine-discontinuation.pdf
11. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=710
12. https://pharmaoffer.com/api-excipient-supplier/mao-inhibitors/phenelzine