Suppliers and packagers for parnate

parnate

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

Suppliers for the Pharmaceutical Drug: PARNATE (Tranylcypromine)

Last updated: August 12, 2025

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Introduction

PARNATE (generic name: Tranylcypromine) is a monoamine oxidase inhibitor (MAOI) primarily prescribed for the treatment of major depressive disorder and atypical depression. Since its FDA approval, it has been a vital therapeutic option, especially for treatment-resistant cases. As demand for PARNATE persists, understanding the global and regional supply landscape is essential for pharmaceutical businesses, healthcare providers, and policy makers. This analysis explores key suppliers, manufacturing dynamics, regulatory statuses, and market considerations surrounding PARNATE.

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Manufacturers of PARNATE

1. Pharmaceutical Companies Producing Tranylcypromine

PARNATE was originally developed by Roche, a Swiss multinational pharmaceutical giant, and was one of the earliest MAOIs introduced in the 1960s.

• Roche: Historically, Roche held the patent and was the exclusive supplier of PARNATE. However, as patent protections expired, generic manufacturing emerged, expanding supply sources.

• Generics Manufacturers: Once the patent expired, numerous pharmaceutical companies worldwide began manufacturing generic Tranylcypromine. These manufacturers often produce the active pharmaceutical ingredient (API) and finished formulations for regional markets.

2. Key API Suppliers

For pharmaceutical brands and generic manufacturers, securing high-quality API is crucial. Notable API suppliers include:

• Sun Pharmaceutical Industries (India): A prominent producer of active pharmaceutical ingredients, including tranylcypromine APIs.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Involved in the manufacture of psychotropic APIs with global export capabilities.

• Hubei Wuchang Pharmaceuticals (China): Known for a broad portfolio of psychiatric API manufacturing.

• Akorn, Inc. (USA): Although primarily known for finished dose forms, some suppliers produce APIs for custom manufacturing or contract research organizations (CROs).

3. Contract Manufacturing Organizations (CMOs)

Several CMOs globally provide custom synthesis of Tranylcypromine API for pharmaceutical companies, providing flexibility in supply chains:

• Thermo Fisher Scientific: Offers synthesis and manufacturing capabilities for APIs, including MAOIs.

• Lonza: Provides contract manufacturing services for complex APIs, including psychotropic drugs.

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Regional and Market-Specific Supply Dynamics

4. North America

In the United States, generic formulations of PARNATE are marketed by multiple manufacturers following the expiration of Roche's patent. Major suppliers include:

• Sandoz (a Novartis division): Provides generic Tranylcypromine tablets.

• Teva Pharmaceutical Industries: Distributes generic PARNATE across North America.

5. Europe

European markets benefit from a mix of original and generic suppliers:

• Roche: Continues to supply the original product in select markets.

• Generics companies: Such as Mylan and Sandoz, supply generic versions compliant with EMA (European Medicines Agency) standards.

6. Asia-Pacific

Rapidly growing manufacturing hubs have expanded API and generic formulations supply:

• Chinese manufacturers like Zhejiang Hisun and Hubei Wuchang are key API suppliers with export licenses.

• Indian pharmaceutical firms like Sun Pharma are significant API producers and marketers.

7. Emerging Markets

Smaller markets in Latin America, Africa, and Southeast Asia are supplied primarily through imports from regional generic manufacturers or through international procurement organizations.

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Regulatory and Quality Considerations

8. Regulatory Approvals and Certifications

Suppliers must ensure compliance with regional quality standards:

• FDA Approval: For API and finished pharmaceuticals in the U.S., manufacturing sites need FDA registration, demonstrating Good Manufacturing Practice (GMP).

• EMA Compliance: European suppliers require EMA certification.

• WHO Prequalification: For some APIs, especially those supplied to developing nations, WHO prequalification indicates acceptable quality standards.

9. Quality Assurance and Bioequivalence

Quality consistency of generics varies among suppliers, necessitating validation studies and strict quality assurance processes. Pharmaceutical companies often require Certificates of Analysis (CoA) and Good Manufacturing Practice (GMP) certifications from suppliers.

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Supply Chain Challenges

10. Market Risks

• Raw Material Availability: Fluctuations in precursor chemical availability and costs can impact API production.

• Regulatory Changes: Stricter regulations may limit the number of qualified suppliers.

• Manufacturing Disruptions: Factors such as pandemic-related closures or geopolitical issues can affect supply continuity.

11. Intellectual Property and Patent Landscape

While the original patent expired long ago, patent or exclusivity rights on formulations or specific manufacturing processes could restrict certain markets or suppliers.

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Emerging Trends and Future Outlook

12. Consolidation and Vertical Integration

Pharmaceutical companies are increasingly integrating API production to secure supply and control quality. Strategic alliances or acquisitions can influence the supplier landscape.

13. Innovation and Biosimilars

Although no biosimilar exists for PARNATE due to its chemical nature, future research might lead to alternative therapies influencing demand and supply.

14. Global Supply Chain Resilience

COVID-19 exposed vulnerabilities in pharmaceutical supply chains. Moving forward, diversified supplier bases and regional manufacturing hubs are prioritized.

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Key Takeaways

• Multiple global suppliers, including original manufacturers like Roche (historically) and an expanding array of generic API producers, supply PARNATE.

• Indian, Chinese, and Western generic manufacturers are dominant in API production and finished formulations.

• Quality standards, regulatory compliance, and supply chain security are critical for ensuring consistent availability.

• Market dynamics are influenced by patent expirations, regional regulations, and geopolitical factors.

• Businesses should prioritize suppliers with GMP certification, robust quality assurance, and proven regulatory compliance.

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FAQs

1. Who are the primary suppliers of PARNATE's API globally?
Key API suppliers include Sun Pharma (India), Zhejiang Hisun Pharmaceutical (China), and Hubei Wuchang Pharmaceuticals (China), among others. These manufacturers supply API for generic formulations worldwide.

2. Is Roche still manufacturing PARNATE?
Roche originally developed PARNATE; however, its production has shifted predominantly to generic manufacturers following patent expiration. Roche's direct supply in certain regions may be limited or discontinued.

3. Are generic versions of PARNATE bioequivalent to the brand?
Yes, generics produced by GMP-compliant manufacturers are required to demonstrate bioequivalence and meet regulatory standards, although quality consistency can vary among suppliers.

4. What are the regulatory considerations when sourcing PARNATE?
Suppliers must have GMP certification, and APIs or formulations must be approved by relevant authorities, such as the FDA in the U.S. or EMA in Europe, to ensure safety and efficacy.

5. How can supply chain disruptions for PARNATE be mitigated?
Diversifying suppliers, establishing contractual agreements with multiple manufacturers, and engaging with suppliers certified for high-quality API production can mitigate risks.

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References

[1] U.S. Food & Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”).
[2] European Medicines Agency. (2022). Summary of Product Characteristics: PARNATE.
[3] IQVIA. (2022). Global Pharmaceutical Market Data.
[4] Pharmeurope. (2023). API Manufacturers Directory.
[5] WHO. (2021). Prequalification of Pharmaceuticals.