Suppliers and packagers for generic pharmaceutical drug: prochlorperazine maleate

prochlorperazine maleate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218515	ANDA	Ajanta Pharma USA Inc.	27241-286-01	100 TABLET in 1 BOTTLE (27241-286-01)	2024-05-09
Ajanta Pharma Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218515	ANDA	Ajanta Pharma USA Inc.	27241-287-01	100 TABLET in 1 BOTTLE (27241-287-01)	2024-05-09
Ajanta Pharma Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218515	ANDA	REMEDYREPACK INC.	70518-4319-0	10 TABLET in 1 BOTTLE, PLASTIC (70518-4319-0)	2025-03-25

Suppliers for the Pharmaceutical Drug: Prochlorperazine Maleate

Last updated: July 29, 2025

Introduction

Prochlorperazine maleate is a selective dopamine receptor D2 antagonist primarily used to control nausea, vomiting, and vertigo. Its applications extend to managing psychosis and anxiety, making it a versatile medication within the antiemetic and antipsychotic classes. Given its widespread clinical use, the procurement and supply chain of prochlorperazine maleate are critical for pharmaceutical manufacturers, healthcare providers, and regulatory bodies.

This report examines the global suppliers of prochlorperazine maleate, focusing on key manufacturers, regional production hubs, and the competitive landscape shaping the drug's availability. Understanding the supply chain intricacies ensures stakeholders can establish secure sourcing channels and anticipate market dynamics.

Global Manufacturing Landscape

Major Producers of Prochlorperazine Maleate

The manufacturing of prochlorperazine maleate spans several regions, mainly concentrated in Asia, Europe, and the United States. These manufacturers produce active pharmaceutical ingredients (APIs) and finished dosage forms, often serving as the main supply sources in international and domestic markets.

1. Chinese Manufacturers

China is a dominant player in the production of APIs including prochlorperazine maleate. Several Chinese pharmaceutical companies hold Good Manufacturing Practice (GMP) certifications and export APIs globally.

• Zhejiang Huangning Pharmaceutical Co., Ltd.: Known for producing various neuroleptics and antiemetics, Zhejiang Huangning is recognized for its capability to manufacture high-purity active ingredients, including prochlorperazine maleate, tailored for international markets.

• Jiangsu Hengrui Medicine Co., Ltd.: While primarily focused on oncology and cardiovascular drugs, Hengrui’s R&D investments include neuroleptic APIs, potentially including prochlorperazine maleate.

• Shandong Jinkang Pharmaceutical Co., Ltd.: Engaged in producing a range of neuropharmaceutical APIs, Jinkang’s facilities are certified for export, especially to Southeast Asia and Africa.

2. Indian Manufacturers

India’s pharmaceutical industry has become a significant exporter of generic APIs and finished medicines, supported by robust regulatory frameworks and cost-efficient manufacturing processes.

• Orchid Healthcare: Specializes in neuroleptic drugs, including prochlorperazine maleate, providing both raw APIs and finished products to global suppliers.

• Madaus India Pvt. Ltd.: Known for producing neuroleptic APIs, this manufacturer is GMP-certified with export licenses to Europe and North America.

3. European and US Suppliers

While European and North American companies are typically more focused on finished dosage forms, some produce APIs for export.

• BASF SE (Germany): As a leading chemical manufacturer, BASF supplies APIs for neuroleptics and antiemetics, including prochlorperazine maleate, under strict quality standards.

• Alpharma (US): A manufacturer specializing in generic antiemetics, including finished formulations of prochlorperazine maleate. Their production complies with US FDA standards.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs facilitate the manufacturing of prochlorperazine maleate, allowing pharmaceutical companies to outsource production:

• Famar (Greece): Offers CMO services for neuroleptic APIs, including formulation development and bulk manufacturing.

• Hovione (Portugal): Known for high-quality APIs and excipients, Hovione manufactures neuroleptic compounds, including prochlorperazine maleate for various clients.

Supply Chain and Regulatory Considerations

Quality Assurance

Suppliers must adhere to regulatory standards such as GMP, Good Laboratory Practice (GLP), and compliance with local authority requirements (e.g., FDA, EMA, PMDA). Certifying bodies inspect manufacturing sites to ensure purity, potency, and safety of APIs, especially for drugs entering stringent markets like the US and EU.

Regulatory Approvals

Manufacturers of prochlorperazine maleate must obtain necessary approvals for both API production and finished drug products. Regulatory dossiers demonstrate compliance with safety and manufacturing standards, influencing supplier credibility.

Supply Chain Risks

Global disruptions, including pandemics, geopolitical tensions, and logistical issues, impact the availability and pricing of prochlorperazine maleate. Diversified sourcing from multiple regions mitigates supply chain risks.

Market Dynamics and Sourcing Strategies

Demand Drivers

• Medical Necessity: The drug's effectiveness in nausea, vertigo, and psychosis management sustains stable demand.
• Off-Patent Status: As a generic drug, prochlorperazine maleate enjoys broad market penetration, with multiple suppliers competing on price and quality.

Pricing Trends

The competitive landscape among generic manufacturers drives down costs, prompting procurement strategies centered on quality certifications and consistent supply records.

Emerging Markets

Growing healthcare infrastructure in Asia, Africa, and Latin America increases demand for affordable prochlorperazine maleate, expanding the supplier base and market access options.

Conclusion

Prochlorperazine maleate's supply chain is characterized by a diversified set of global manufacturers primarily situated in China, India, Europe, and the United States. The key to establishing a reliable sourcing channel resides in verifying GMP compliance, regulatory approvals, and consistent quality standards.

Procurers should maintain relationships with reputable API producers, diversify supply sources, and continuously monitor geopolitical and logistical developments to ensure uninterrupted supply.

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Key Takeaways

• Major API production centers for prochlorperazine maleate are in China and India, with European and US players primarily providing finished dosage forms.
• Maintaining quality standards per GMP and regulatory approvals is paramount for supplier credibility.
• Supply chain risks necessitate diversification across regions and suppliers.
• The generic nature of prochlorperazine maleate fosters aggressive pricing; quality remains a differentiating factor.
• Emerging markets expand demand, influencing global supply strategies and supplier co-operation.

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FAQs

Q1: What are the leading global suppliers of prochlorperazine maleate?
A1: Leading suppliers include Chinese companies like Zhejiang Huangning Pharmaceutical, Indian firms such as Orchid Healthcare, European manufacturers like BASF SE, and US-based generic producers like Alpharma.

Q2: How can buyers verify supplier quality for prochlorperazine maleate?
A2: Buyers should verify GMP certification, regulatory approvals, and conduct supplier audits. Certifications from recognized authorities like the FDA, EMA, and local GMP compliance are critical indicators of quality.

Q3: Are there risks associated with sourcing prochlorperazine maleate from China or India?
A3: Yes—potential risks include quality inconsistencies, intellectual property concerns, and geopolitical uncertainties. Mitigating these risks involves strict qualification processes and diversifying suppliers.

Q4: How does regulation influence the supply of prochlorperazine maleate?
A4: Regulatory standards influence supplier eligibility through GMP certification and approval of manufacturing facilities. Compliance ensures market access and stable supply.

Q5: What emerging markets are expanding the demand for prochlorperazine maleate?
A5: Countries in Southeast Asia, Africa, and Latin America are experiencing increased demand due to expanding healthcare infrastructure and affordability, opening new sourcing opportunities.

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Sources

[1] United States Pharmacopeia (USP) Database.
[2] European Medicines Agency (EMA) Database.
[3] Industry reports on API manufacturing, Pharma IQ.
[4] Company websites and public filings of Zhejiang Huangning, Orchid Healthcare, BASF, and Hovione.
[5] Market analysis reports from GlobalData and IQVIA.