Suppliers and packagers for generic pharmaceutical drug: PERPHENAZINE

PERPHENAZINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5060-21	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5060-21)	1998-12-31
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5061-21	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-21)	1998-12-31
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5061-28	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-28)	1998-12-31
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5062-21	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5062-21)	1998-12-31
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5062-28	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5062-28)	1998-12-31
Ph Health	PERPHENAZINE	perphenazine	TABLET;ORAL	040226	ANDA	Endo USA, Inc.	0603-5063-21	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5063-21)	1998-12-31

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Perphenazine

Introduction
Perphenazine, a typical antipsychotic agent belonging to the phenothiazine class, is primarily used for managing schizophrenia, psychosis, and other related psychiatric disorders. Although its manufacture dates back several decades, it remains a vital medication in psychiatric treatment. The global supply chain for perphenazine involves a diverse set of suppliers spanning active pharmaceutical ingredient (API) manufacturers to finished drug product producers, mainly driven by established pharmaceutical companies and contract manufacturing organizations (CMOs).

This analysis explores the landscape of perphenazine suppliers, highlighting key players, manufacturing capacities, regulatory considerations, and emerging trends. A comprehensive understanding of the supply chain is essential for pharmaceutical companies, healthcare providers, and investors seeking to navigate market dynamics, ensure supply chain resilience, and identify potential sourcing opportunities.

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Global API Suppliers for Perphenazine

The foundation of perphenazine supply is its active pharmaceutical ingredient (API). API manufacturing companies possess the chemical synthesis expertise necessary for scalable production while adhering to stringent Good Manufacturing Practices (GMP).

Major API Manufacturers

1. Teva Pharmaceutical Industries Ltd.
As one of the largest generic pharmaceutical companies globally, Teva supplies a wide variety of antipsychotics, including perphenazine. Teva's robust API production facilities across Israel and Europe focus on GMP-compliant manufacturing, providing a reliable supply to global markets. The company’s extensive R&D capabilities help optimize synthesis routes for efficiency.

2. Hikma Pharmaceuticals
Egyptian-based Hikma is a notable supplier of generic APIs, including phenothiazine derivatives such as perphenazine. Hikma’s API manufacturing units in the Middle East and North Africa serve regional and international clients, emphasizing quality and cost-effectiveness.

3. Jiangsu Hengrui Medicine Co., Ltd.
A leading Chinese pharmaceutical company, Hengrui leverages advanced chemical synthesis platforms to produce phenothiazine APIs. Its capacity expansion aligns with global demand, although regulatory hurdles may influence export logistics.

4. Alvogen
Alvogen's API manufacturing arm supplies active ingredients for various psychiatric medications. Its facilities in Europe and Asia follow rigorous GMP standards, ensuring high-quality API production.

5. Dr. Reddy's Laboratories
India-based Dr. Reddy’s manufactures phenothiazine derivatives, including perphenazine, leveraging cost-advantageous manufacturing infrastructure. It supplies both domestic and international markets, emphasizing affordability.

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Niche and Specialty API Suppliers

While large firms dominate, several smaller or specialized API producers focus on niche production, custom synthesis, or contract manufacturing for pharmaceutical companies. These suppliers often serve clients seeking rapid scale-up or specific crystalline forms optimized for bioavailability.

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Finished Dosage Form Manufacturers

In addition to API suppliers, several pharmaceutical companies manufacture and distribute finished perphenazine products, including tablets and injectables, globally.

Key established manufacturers include:

• Sandoz (Novartis): A leading generic pharmaceutical producer offering perphenazine in multiple markets.
• Teva Pharmaceuticals: Besides API, Teva manufactures various formulations of perphenazine for its global customer base.
• Lannett Company: A U.S.-based manufacturer of generic psychiatric medications, including perphenazine.
• Many regional generic producers: Leveraging domestically sourced API to supply localized markets across North America, Europe, and Asia.

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Regulatory and Quality Considerations

The pharmaceutical supply chain for perphenazine must conform to strict regulatory standards, notably the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities. Regulatory approval impacts supplier selection, with quality audits and GMP compliance being non-negotiable factors. Suppliers lacking rigorous quality assurance may pose risks of supply interruptions or regulatory sanctions.

Moreover, quality consistency across batches and adherence to cGMP (Current Good Manufacturing Practice) standards are critical, especially for psychiatric medications where dosing precision and purity directly impact patient safety.

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Emerging Trends and Market Dynamics

1. Geographic Diversification
Recent geopolitical and supply chain disruptions — notably during the COVID-19 pandemic — have underscored the need for geographic diversification of API sourcing. Companies are increasingly engaging multiple suppliers across different regions to mitigate risks.

2. Contract Manufacturing Growth
Outsourcing API synthesis to CMOs has gained traction, allowing pharmaceutical firms to reduce costs and expedite time-to-market. The complexity of phenothiazine synthesis benefits from specialized chemical production facilities, often located in Asia and Eastern Europe.

3. Regulatory Complexity
Global harmonization efforts aim to streamline approvals for API manufacturers, which could expand supplier options. However, divergent standards still pose barriers, requiring careful vetting.

4. Sustainability and Quality Innovation
Environmental considerations influence supplier selection, with some companies prioritizing sustainable synthesis processes and greener manufacturing practices.

5. Patent Status
Because perphenazine is off-patent, generic manufacturers dominate the landscape; however, patent restrictions on manufacturing processes may influence supplier choices and market exclusivity.

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Supply Chain Challenges

Despite a relatively mature market, supply chain challenges persist:

• Raw Material Availability: Chemical precursors—such as phenothiazine derivatives—may face shortages due to raw material constraints or geopolitical factors.
• Regulatory Gaps: Stringent requirements for API validation increase compliance costs and can delay supplier qualification.
• Pricing Pressures: Competitive markets exert downward pressure on API prices, impacting suppliers’ profitability and investment capacity.
• Quality Risks: Ensuring batch-to-batch consistency remains critical, especially for psychiatric drugs requiring precise dosing.

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Future Outlook

The future landscape for perphenazine suppliers will likely see increased diversification, owing to geopolitical shifts, supply chain resilience strategies, and technological advancements. Innovations in synthesis methods could reduce production costs and environmental impact, thereby broadening supplier pools. Moreover, as more nations strengthen regulatory frameworks, suppliers capable of complying with global standards will gain preferential access to markets.

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Key Takeaways

• Diverse API Supply Sources: Major players like Teva, Hikma, Hengrui, and Dr. Reddy’s dominate API manufacturing for perphenazine, complemented by smaller specialty firms.
• Regulatory Compliance Essential: Suppliers must adhere to GMP standards with rigorous quality assurance protocols to meet international standards.
• Geographic Diversification Benefits: Sourcing from multiple regions mitigates risks associated with geopolitical instability and raw material shortages.
• Outsourcing Growth: Contract manufacturing organizations are increasingly pivotal in ensuring scalable, cost-effective API production.
• Market Dynamics Influence Supply Security: Price competition, regulatory requirements, and sustainability considerations shape the supplier landscape.

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FAQs

Q1: What are the primary regions producing perphenazine API today?
A1: North America (via large multinationals), Europe (notably Teva), China (Hengrui), and India (Dr. Reddy’s) are key regions involved in API manufacturing.

Q2: Are there specific regulatory hurdles for importing perphenazine API?
A2: Yes. Manufacturers and importers must comply with local authorities’ GMP standards, novel manufacturing process approvals, and sometimes drug-specific registration protocols.

Q3: How do I evaluate the quality of a perphenazine API supplier?
A3: Assess GMP compliance, quality certifications (e.g., ISO), batch consistency data, audit reports, and historical compliance records.

Q4: What impact has the COVID-19 pandemic had on perphenazine supply chains?
A4: It highlighted vulnerabilities, prompting increased diversification, stockpiling, and strategic sourcing to ensure ongoing supply and mitigate disruptions.

Q5: Are there opportunities for new suppliers to enter the market?
A5: Yes. Advances in synthesis technologies and growing demand for affordable mental health medications create opportunities for qualified new entrants to establish manufacturing capabilities.

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Sources

1. U.S. Food and Drug Administration (FDA). Pharmaceutical Quality Resources.
2. European Medicines Agency (EMA). API suppliers database.
3. Global Industry Analysts. Phenothiazine Market Reports.
4. Company websites and publicly available filings for Teva, Hikma, Jiangsu Hengrui, Dr. Reddy’s, and others.
5. Market intelligence reports on pharmaceutical active ingredient manufacturing trends.