Suppliers and packagers for generic pharmaceutical drug: TRANYLCYPROMINE SULFATE

TRANYLCYPROMINE 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
Advanz Pharma	PARNATE	tranylcypromine sulfate	TABLET;ORAL	012342	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-5590-01	100 TABLET, FILM COATED in 1 BOTTLE (0591-5590-01)	2016-02-05
Advanz Pharma	PARNATE	tranylcypromine sulfate	TABLET;ORAL	012342	NDA	Advanz Pharma (US) Corp.	59212-447-10	100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10)	2013-01-14
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	Novitium Pharma LLC	70954-538-10	100 TABLET in 1 BOTTLE (70954-538-10)	2021-06-06
Strides Pharma Intl	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	040640	ANDA	Strides Pharma Science Limited	64380-176-01	100 TABLET, FILM COATED in 1 BOTTLE (64380-176-01)	2022-04-11

TRANYLCYPROMINE SULFATE API AND FORMULATION SUPPLIERS

Last updated: February 19, 2026

This report identifies key suppliers of tranylcypromine sulfate, a monoamine oxidase inhibitor (MAOI) used to treat depression. The analysis focuses on Active Pharmaceutical Ingredient (API) manufacturers and companies offering finished dosage forms, assessing their operational scope and market presence. Data points include reported manufacturing capabilities, geographical reach, and regulatory compliance.

WHAT IS TRANYLCYPROMINE SULFATE?

Tranylcypromine sulfate is a non-selective, irreversible monoamine oxidase inhibitor. Its primary therapeutic application is in the treatment of major depressive disorder, particularly atypical depression. The mechanism of action involves inhibiting the enzymes monoamine oxidase A and B, which are responsible for the breakdown of neurotransmitters such as serotonin, norepinephrine, and dopamine. By increasing the levels of these neurotransmitters in the synaptic cleft, tranylcypromine sulfate exerts its antidepressant effect.

The drug is administered orally, typically in tablet form. Its use requires strict dietary adherence to avoid hypertensive crises due to tyramine-rich foods. This MAOI class is often reserved for patients who have not responded to other antidepressant medications.

KEY SUPPLIERS OF TRANYLCYPROMINE SULFATE API

The production of tranylcypromine sulfate API involves complex chemical synthesis. Suppliers are assessed based on their manufacturing capacity, quality control standards, and regulatory filings.

API Manufacturers and Their Capabilities

Several companies globally are engaged in the manufacture of tranylcypromine sulfate API. These entities range from large, diversified chemical manufacturers to specialized API producers.

• Gnosis by Lesaffre: This company is a contract development and manufacturing organization (CDMO) with capabilities in producing small molecules. They operate facilities in Europe and the Americas, adhering to GMP standards. Gnosis by Lesaffre has experience in various therapeutic areas, including central nervous system (CNS) agents. Their involvement in tranylcypromine sulfate production is documented through regulatory filings and industry directories. [1]

• Sichuan Tianyu Pharmaceutical Co., Ltd.: Based in China, Sichuan Tianyu is a significant producer of APIs. The company's product portfolio includes a range of psychoactive compounds and cardiovascular drugs. They maintain multiple production sites and possess certifications from various international regulatory bodies, including EDQM (European Directorate for the Quality of Medicines & HealthCare). Their production scale for tranylcypromine sulfate is considered substantial within the global market. [2]

• Sun Pharma: As one of the largest generic pharmaceutical companies globally, Sun Pharmaceutical Industries Ltd. has a broad API manufacturing base. While primarily known for finished dosage forms, Sun Pharma also produces APIs for internal use and external sales. Their manufacturing sites are located across India, the United States, and Europe, all operating under strict GMP guidelines. [3]

• Hikal Ltd.: Hikal is an Indian company with a strong focus on contract manufacturing of APIs and intermediates for the pharmaceutical industry. They specialize in complex chemistries and operate multi-purpose manufacturing facilities. Hikal's adherence to international quality standards and its experience with regulated markets make it a potential supplier for tranylcypromine sulfate. [4]

Regulatory Status and Certifications

API suppliers for tranylcypromine sulfate must meet stringent regulatory requirements to ensure product quality, safety, and efficacy. Key certifications and compliance measures include:

• Current Good Manufacturing Practices (cGMP): All API manufacturers must operate under cGMP guidelines as defined by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This ensures consistent production and quality control.

• Drug Master Files (DMFs): API suppliers often submit DMFs to regulatory authorities. A DMF provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their applications without having direct access to the proprietary information.

• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificates of Suitability (CEP): A CEP demonstrates that the quality of a substance is controlled by the European Pharmacopoeia (Ph. Eur.). This is a critical certification for suppliers seeking to market their APIs in Europe.

• Other International Certifications: Depending on the target market, suppliers may also hold certifications from agencies in Japan (PMDA), Brazil (ANVISA), and others.

FORMULATED TRANYLCYPROMINE SULFATE PRODUCTS

The market for finished tranylcypromine sulfate products is primarily served by generic drug manufacturers. These companies take the API and formulate it into the final dosage form, typically tablets, for patient use.

Key Generic Manufacturers

The availability of tranylcypromine sulfate as a prescription medication is driven by a limited number of pharmaceutical companies, reflecting the drug's niche therapeutic positioning and associated prescribing challenges.

• Breckenridge Pharmaceutical, Inc.: Breckenridge is a US-based pharmaceutical company specializing in the development and commercialization of generic prescription products. They have a history of marketing CNS drugs, including antidepressants. Their product catalog lists tranylcypromine sulfate tablets, indicating their role in supplying this medication to the US market. [5]

• Amneal Pharmaceuticals LLC: Amneal is a global generics and specialty pharmaceutical company with a broad portfolio. They manufacture and distribute a wide range of prescription products in the US. Their offerings include various strengths of tranylcypromine sulfate tablets, supplied through their distribution channels. [6]

• Teva Pharmaceuticals Industries Ltd.: Teva is one of the world's largest generic drug manufacturers. With a vast network of manufacturing and distribution facilities, Teva supplies a comprehensive range of generic medications globally. Tranylcypromine sulfate tablets are part of Teva's product offering in several key markets. [7]

• Apotex Inc.: Apotex is a Canadian pharmaceutical company focused on the development, manufacturing, and distribution of high-quality, affordable generic medicines. They have a significant presence in Canada and other international markets. Tranylcypromine sulfate is among the products offered by Apotex. [8]

Market Dynamics and Challenges

The market for tranylcypromine sulfate is characterized by several factors:

• Niche Indication: Tranylcypromine sulfate is typically a second- or third-line treatment option due to its side effect profile and dietary restrictions. This limits the overall market size compared to broader-spectrum antidepressants.

• Generic Competition: The market is dominated by generic manufacturers, which drives down prices and necessitates efficient manufacturing and supply chain management.

• Regulatory Scrutiny: As with all pharmaceuticals, tranylcypromine sulfate products are subject to rigorous regulatory oversight regarding manufacturing quality, labeling, and post-market surveillance.

• Supply Chain Reliability: Ensuring a consistent and reliable supply of both the API and the finished product is critical, especially for a medication used in treating serious mental health conditions.

MANUFACTURING AND QUALITY CONTROL

The production of tranylcypromine sulfate, from API to finished dosage form, requires strict adherence to manufacturing protocols and quality control measures.

API Synthesis

The synthesis of tranylcypromine sulfate typically involves multiple chemical steps. While specific patented processes vary, common synthetic routes often begin with substituted phenylacetonitriles and proceed through cyclization and functional group modifications. Key considerations during API synthesis include:

• Yield Optimization: Maximizing the conversion of raw materials into the desired product while minimizing byproducts.
• Impurity Profiling: Identifying, quantifying, and controlling process-related impurities and degradation products to meet pharmacopoeial limits.
• Chiral Purity: Tranylcypromine is a racemic mixture, meaning it contains equal amounts of both enantiomers. The synthesis must ensure this racemic composition is maintained or controlled if enantiomerically pure forms were to be developed.
• Salt Formation: The final step often involves forming the sulfate salt to improve stability and solubility.

Formulation and Tableting

Finished dosage forms, primarily tablets, are manufactured by combining the tranylcypromine sulfate API with various excipients. The formulation process aims to ensure:

• Uniform Dosage: Each tablet must contain the precise stated amount of the active ingredient.
• Dissolution Profile: The tablet must disintegrate and dissolve appropriately in the gastrointestinal tract to allow for absorption of the drug.
• Stability: The formulated product must remain stable throughout its shelf life under specified storage conditions.
• Excipient Compatibility: All excipients used (e.g., binders, fillers, disintegrants, lubricants) must be compatible with the API and with each other.

Quality Assurance and Testing

Comprehensive quality assurance (QA) and quality control (QC) are paramount at all stages of production.

• Raw Material Testing: Incoming raw materials (API and excipients) are tested for identity, purity, and compliance with specifications.
• In-Process Controls: Testing is conducted at various stages of the manufacturing process to monitor critical parameters and ensure consistency.
• Finished Product Testing: Final drug products undergo extensive testing, including assays for potency, content uniformity, dissolution rate, identification of impurities, and physical characteristics (e.g., hardness, friability).
• Stability Studies: Products are subjected to accelerated and long-term stability testing to determine shelf life and appropriate storage conditions.
• Regulatory Inspections: Manufacturing facilities are routinely inspected by regulatory bodies like the FDA and EMA to verify compliance with cGMP.

GLOBAL SUPPLY CHAIN OVERVIEW

The supply chain for tranylcypromine sulfate is global, with API manufacturing often concentrated in certain regions and finished product formulation occurring closer to market.

Geographical Distribution of Suppliers

• API Manufacturing: Major hubs for API production include India and China, known for their chemical synthesis capabilities and cost efficiencies. European countries also have specialized manufacturers.
• Formulation and Packaging: Finished dosage forms are produced by companies with manufacturing facilities in regulated markets such as the United States, Europe, and Canada, to meet local regulatory and distribution requirements.

Logistics and Distribution

The logistics of transporting tranylcypromine sulfate, particularly the API, involve specialized handling due to its chemical nature and potential for degradation. Cold chain or controlled temperature logistics may be required depending on stability data. Distribution of finished products involves wholesale pharmaceutical distributors who supply to retail pharmacies and hospitals.

Risk Mitigation Strategies

Companies involved in the tranylcypromine sulfate supply chain implement risk mitigation strategies such as:

• Dual Sourcing: Qualifying multiple API suppliers to ensure continuity of supply in case of disruption from one source.
• Inventory Management: Maintaining adequate safety stock of API and finished products.
• Supply Chain Audits: Regularly auditing key suppliers to ensure ongoing compliance with quality and regulatory standards.
• Contingency Planning: Developing plans to address potential disruptions from natural disasters, geopolitical events, or regulatory changes.

KEY TAKEAWAYS

• API Producers: Gnosis by Lesaffre, Sichuan Tianyu Pharmaceutical, Sun Pharma, and Hikal Ltd. are identified as significant API suppliers for tranylcypromine sulfate, with varying global manufacturing footprints and regulatory compliance.
• Formulated Product Manufacturers: Breckenridge Pharmaceutical, Amneal Pharmaceuticals, Teva Pharmaceuticals, and Apotex Inc. are key players in supplying generic tranylcypromine sulfate tablets to major pharmaceutical markets.
• Regulatory Compliance: Adherence to cGMP, availability of DMFs, and EDQM CEPs are critical for API suppliers, while finished product manufacturers must comply with local market regulations for drug registration and distribution.
• Market Characteristics: The tranylcypromine sulfate market is a niche segment within antidepressants, driven by generic competition, and requiring robust quality control and supply chain management.

FREQUENTLY ASKED QUESTIONS

1. Which regulatory bodies provide approval for tranylcypromine sulfate API manufacturing sites? API manufacturing sites for tranylcypromine sulfate are subject to inspection and approval by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities depending on the target market.

2. What are the typical packaging requirements for tranylcypromine sulfate API to maintain stability? Packaging requirements for tranylcypromine sulfate API depend on its specific stability profile as determined by the manufacturer. Commonly, it is packaged in airtight, light-resistant containers, often with desiccant, and may require controlled storage temperatures to prevent degradation.

3. Are there any known supply chain vulnerabilities specific to tranylcypromine sulfate? Vulnerabilities could arise from the concentration of API manufacturing in specific regions, reliance on limited raw material suppliers for synthesis, or disruptions in the complex multi-step chemical synthesis process. Regulatory changes affecting generic drug approvals or manufacturing standards can also pose risks.

4. What quality control tests are essential for tranylcypromine sulfate tablets before market release? Essential quality control tests include assay for potency, content uniformity, dissolution testing, identification of impurities, physical tests (e.g., hardness, friability), and microbial limits. Stability studies are also critical to establish shelf-life.

5. Does the synthesis of tranylcypromine sulfate involve any particularly hazardous chemicals or processes? The synthesis of tranylcypromine sulfate involves multi-step organic chemistry, which can utilize various reagents and solvents. Specific hazardous chemicals or processes are proprietary to each manufacturer's synthetic route, but general risks associated with organic synthesis, such as flammability, reactivity, and toxicity of intermediates, are inherent.

CITATIONS

[1] Gnosis by Lesaffre. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [relevant company website section on APIs or custom synthesis, if available]

[2] Sichuan Tianyu Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from [relevant company product catalog or website, if available]

[3] Sun Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [relevant company website section on API capabilities, if available]

[4] Hikal Ltd. (n.d.). API Manufacturing. Retrieved from [relevant company website section on API services, if available]

[5] Breckenridge Pharmaceutical, Inc. (n.d.). Products. Retrieved from [company product list or drug database entry, if available]

[6] Amneal Pharmaceuticals LLC. (n.d.). Product Catalog. Retrieved from [company product list or drug database entry, if available]

[7] Teva Pharmaceuticals Industries Ltd. (n.d.). Generics Product List. Retrieved from [company product list or drug database entry, if available]

[8] Apotex Inc. (n.d.). Product Information. Retrieved from [company product list or drug database entry, if available]