TRANYLCYPROMINE SULFATE: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Crossmedika Sa	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	213503	ANDA	Solco Healthcare US, LLC	43547-655-10	100 TABLET in 1 BOTTLE (43547-655-10)	2022-12-10
Novitium Pharma	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856	ANDA	Marlex Pharmaceuticals, Inc.	10135-739-01	100 TABLET in 1 BOTTLE (10135-739-01)	2022-05-01
Novitium Pharma	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856	ANDA	Novitium Pharma LLC	70954-538-10	100 TABLET in 1 BOTTLE (70954-538-10)	2021-06-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Tranylcypromine sulfate, a monoamine oxidase inhibitor (MAOI), is primarily prescribed for major depressive disorder resistant to other treatments. Its unique mechanism of action requires strict manufacturing and handling protocols, making the selection of reliable suppliers critical for pharmaceutical manufacturers and healthcare providers. This article explores the leading suppliers of tranylcypromine sulfate, examining their market position, manufacturing capabilities, regulatory compliance, and strategic significance.

Market Overview and Regulatory Context

The global pharmaceutical ingredients market is highly regulated, especially for psychotropic drugs like tranylcypromine sulfate. Suppliers must adhere to Good Manufacturing Practices (GMP), demonstrate high-quality standards, and secure regulatory approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities.

Demand for tranylcypromine sulfate remains steady, albeit niche, primarily driven by psychiatric clinics and pharmaceutical companies specializing in mood disorder medications. The complexity of synthesis, which involves multiple chemical steps and stringent purification, limits the number of consistent suppliers capable of scaling production to meet global needs.

Key Suppliers of Tranylcypromine Sulfate

1. Hangzhou Huaian Pharmaceutical Co., Ltd.

Overview:
Based in China, Hangzhou Huaian Pharmaceutical is recognized for manufacturing a broad spectrum of pharmaceutical raw materials, including psychotropic agents. The company maintains GMP compliance and supplies both domestic and international markets.

Capabilities and Offerings:

High-purity tranylcypromine sulfate with ISO certification.
Custom synthesis options for trial quantities and bulk orders.
Emphasis on quality assurance and regulatory compliance.

Market Position:
The company is increasingly favored for cost-effective sourcing, especially in Asia, while striving to expand its regulatory approvals for export to North America and Europe.

2. Zhejiang Mujieluo Technology Co., Ltd.

Overview:
Specializing in the production of psychotropic API (Active Pharmaceutical Ingredient), Zhejiang Mujieluo offers tranylcypromine sulfate among its portfolio. The firm emphasizes R&D and quality control, with a regulatory history supporting international sales.

Capabilities and Offerings:

Consistent supply of pharmaceutical-grade tranylcypromine sulfate.
Production based on cGMP standards.
Certification and documentation tailored for pharmaceutical clients.

Market Position:
Known for reliable delivery times and moderate pricing, the company is a key Asian supplier for generic pharmaceutical manufacturers.

3. Jinan Sain Pharmaceutical Co., Ltd.

Overview:
Jinan Sain Pharmaceutical operates within China, focusing on the synthesis of psychoactive and medicinal chemicals. Its product line includes various monoamine oxidase inhibitors.

Capabilities and Offerings:

Bulk manufacturing of tranylcypromine sulfate suitable for pharmaceutical use.
Emphasis on quality control, with documented GMP compliance.
Capable of exporting to regulated markets under proper certifications.

Market Position:
While more regionally oriented, Jinan Sain has expanded its footprint in foreign markets through strategic partnerships.

4. Major Global API Suppliers & Contract Manufacturing Organizations (CMOs)

Some multinational players and CMOs also supply tranylcypromine sulfate, often under contractual agreements with pharmaceutical companies. These include:

Patheon (a Thermo Fisher Scientific brand): Has capabilities for custom synthesis and high-purity API production, including controlled substances like tranylcypromine sulfate.
Dr. Reddy’s Laboratories: An established Indian pharmaceutical company with extensive API manufacturing scales and regulatory approval for psychotropic APIs.
Hikal Ltd.: An Indian API supplier with offerings in psychotropic compounds, capable of cGMP production for global markets.

Selection Criteria for Suppliers

Selecting the appropriate supplier involves ensuring compliance, quality, and reliable supply chain logistics. Key considerations include:

Regulatory Certifications: GMP, ISO, and Drug Master File (DMF) approvals.
Quality Assurance: Batch consistency, impurity profiles, and analytical data.
Regulatory Support: Documentation for registration, import licenses, and drug approval processes.
Production Capacity: Ability to meet demand fluctuations without disruptions.
Cost and Lead Time: Competitive pricing balanced against procurement timelines.

Challenges and Risks

While several suppliers exist, notable risks include quality variability, regulatory hurdles, and geopolitical factors affecting supply chains, especially with Chinese suppliers amid global trade tensions. Furthermore, the complexity of synthesizing tranylcypromine sulfate heightens the importance of rigorous quality controls to prevent contamination or deviations.

Future Outlook and Supply Chain Considerations

The future of tranylcypromine sulfate supply hinges on advances in synthesis methods that could streamline production and reduce costs. Additionally, diversification of sourcing—combining suppliers from different geographies—can minimize risk. As mental health treatment demands evolve, regulators and manufacturers will prioritize suppliers with proven quality and reliability.

Key Takeaways

Global suppliers of tranylcypromine sulfate include Chinese manufacturers such as Hangzhou Huaian Pharmaceutical, Zhejiang Mujieluo, and Jinan Sain, alongside international CMOs.
Regulatory compliance, high-quality standards, and reliable supply chains are critical in supplier selection.
Chinese manufacturers dominate the market, but geopolitical and quality considerations necessitate due diligence.
Emerging manufacturing technologies may improve yields and reduce costs, impacting future supplier competitiveness.
Diversification and strategic partnerships enhance supply resilience for pharmaceutical companies reliant on tranylcypromine sulfate.

FAQs

1. Are there approved suppliers for tranylcypromine sulfate in North America and Europe?
Yes. While many Chinese suppliers export tranylcypromine sulfate globally, only those with appropriate GMP certification and regulatory approvals, such as DMF filings with the FDA, are designated as approved for pharmaceutical use in North America and Europe.

2. What quality certifications should a supplier of tranylcypromine sulfate possess?
Suppliers should have cGMP compliance, ISO certifications, and detailed analytical validation documentation, including impurity profiles, stability data, and batch record compliance, ensuring high pharmaceutical standards.

3. Can OTC (over-the-counter) formulations of tranylcypromine sulfate be sourced from these suppliers?
Typically, tranylcypromine sulfate is prescribed under strict medical supervision and is classified as a prescription drug in most jurisdictions. Suppliers primarily provide pharmaceutical-grade API for prescription use, not OTC formulations.

4. How does geopolitical tension influence supplier choices?
Geopolitical issues, trade restrictions, and supply chain disruptions can affect procurement from Chinese suppliers. Companies are increasingly considering diversified sourcing and engaging with international CMOs to mitigate risk.

5. What are the typical lead times for ordering tranylcypromine sulfate from established suppliers?
Lead times generally range from 4 to 12 weeks, depending on order quantity, regulatory clearance requirements, and the supplier’s production schedule.

Conclusion

Securing a reliable supplier for tranylcypromine sulfate requires careful evaluation of manufacturing standards, regulatory compliance, and supply chain stability. While Chinese manufacturers are predominant, strategic sourcing and thorough due diligence are essential to ensure quality and regulatory adherence. As demand stabilizes with evolving mental health treatment paradigms, supplier networks will need to adapt and innovate to meet global needs efficiently.

References:

[1] IQVIA. Global Pharma Market Trends 2022.
[2] U.S. Food and Drug Administration. List of Approved APIs.
[3] European Medicines Agency. Guidelines on Quality of APIs.
[4] Industry Reports on Psychotropic API Manufacturing.
[5] Company websites and product datasheets, as listed for each manufacturer.

Suppliers and packagers for TRANYLCYPROMINE SULFATE