Suppliers and packagers for CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	214542	ANDA	Sandoz, Inc.	0781-4027-53	120 mL in 1 BOTTLE, PLASTIC (0781-4027-53)	2023-03-31
Genus	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	214542	ANDA	Sandoz, Inc.	0781-4028-22	240 mL in 1 BOTTLE, PLASTIC (0781-4028-22)	2023-03-31
Rubicon	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	216678	ANDA	Advagen Pharma Ltd	72888-457-01	120 mL in 1 BOTTLE (72888-457-01)	2025-10-10

Suppliers for the Pharmaceutical Drug: CHLORPROMAZINE HYDROCHLORIDE

Last updated: July 30, 2025

Introduction

Chlorpromazine Hydrochloride, a pioneering antipsychotic medication, remains integral in psychiatric treatment for conditions such as schizophrenia, psychosis, and manic-depressive disorders. Despite the advent of newer antipsychotics, chlorpromazine retains wholesale and clinical importance due to its established efficacy and cost-effectiveness. Ensuring reliable sourcing of chlorpromazine hydrochloride is essential for pharmaceutical companies, healthcare providers, and generics manufacturers seeking consistent quality and supply. This analysis details the leading suppliers globally, the manufacturing landscape, and factors influencing procurement decisions in the chlorpromazine hydrochloride supply chain.

Overview of Chlorpromazine Hydrochloride

Chlorpromazine hydrochloride is a phenothiazine derivative that exerts antipsychotic activity primarily through dopamine receptor antagonism. It is available in various formulations, including tablets, injectable solutions, and compounded preparations. Its synthesis involves complex chemical processes requiring high-grade intermediates and strict compliance with Good Manufacturing Practices (GMP). As a generic drug, chlorpromazine hydrochloride is produced by multiple manufacturers across different regions, contributing to its global availability.

Major Supplier Regions

The supply chain for chlorpromazine hydrochloride is dispersed across several key regions, each with distinct capabilities and regulatory frameworks:

1. India

India represents a substantial portion of the global pharmaceutical raw material and active pharmaceutical ingredient (API) production sector. Companies such as Sun Pharmaceutical Industries, IPCA Labs, and J.B. Chemicals have established robust APIs manufacturing capabilities, including chlorpromazine hydrochloride. Indian producers benefit from cost advantages, efficient manufacturing processes, and a large export footprint, especially to North America and Europe. The Indian regulatory environment, governed by the Central Drugs Standard Control Organization (CDSCO), emphasizes compliance with international standards, facilitating global acceptance.

2. China

China's API industry is a dominant force globally, with numerous chemical and pharmaceutical producers capable of manufacturing chlorpromazine hydrochloride. Companies like Zhejiang Huahai Pharmaceutical and Shanghai-based Yabang Medicine serve both domestic and international markets. Chinese suppliers are known for scale, technological innovation, and competitive pricing. However, navigating regulatory approval and ensuring quality compliance are critical for overseas buyers, given China's evolving regulatory landscape under the National Medical Products Administration (NMPA).

3. Europe

Europe hosts several established pharmaceutical ingredient suppliers beloved for stringent quality standards. Companies such as AbbVie (formerly part of Abbott) and Merck KGaA manufacture APIs, including chlorpromazine hydrochloride, often catering to licensed manufacturing and research institutions. European suppliers emphasize high quality, regulatory compliance with EMA standards, and sustainable manufacturing practices. These suppliers typically command premium pricing but offer reliable supply chains ideal for markets requiring strict regulatory oversight.

4. United States

The US market relies on imported APIs, primarily sourced from India and China, due to the limited number of domestic API producers for chlorpromazine hydrochloride. US-based distributors and brokers facilitate supply chain access, ensuring compliance with FDA regulations and pharmaceutical standards. The US Food and Drug Administration (FDA) oversees importation and quality assurance, emphasizing stringent testing and validation processes.

Leading Suppliers and Manufacturers

Supplier	Region	Capabilities	Key Attributes	Certification & Compliance
Sun Pharmaceutical Industries	India	Large-scale API production	Cost-effective, substantial export capacity	GMP, WHO-GMP, FDA-approved facilities
IPCA Labs	India	Wide API portfolio	Experienced in phenothiazine derivatives	GMP, ISO certifications
Zhejiang Huahai Pharmaceutical	China	Major chemical synthesis	Competitive pricing, high volume	NMPA approval, cGMP
Merck KGaA	Europe	High-quality APIs	Strong regulatory compliance	EMA-approved facilities
Yabang Medicine	China	Specialized API manufacturer	Flexible manufacturing	ISO, GMP certification

Factors Influencing Procurement and Supplier Selection

• Regulatory Compliance: Suppliers must meet GMP standards, certifications (e.g., WHO-GMP, EU-GMP, FDA), and undergo regular audits to assure quality.
• Supply Chain Reliability: Consistent delivery schedules, capacity to scale, and robust logistics are crucial, especially considering global disruptions.
• Cost Efficiency: Competitive pricing remains vital, influencing selection especially among bulk purchasers or therapeutics companies.
• Quality Assurance: Stringent QC protocols, stability studies, and purity requirements govern supplier evaluations.
• Geopolitical Dynamics: Trade policies, tariffs, and import/export restrictions can affect supplier availability, with geopolitical tensions possibly disrupting supply chains.

Emerging Trends and Challenges

• Regulatory Evolution: Stricter international standards and post-market surveillance increase the due diligence required for supplier acceptance.
• Supply Chain Diversification: Companies diversify to mitigate risks associated with dependency on single-region suppliers, especially amid COVID-19 pandemic challenges.
• Technological Advancements: Improved synthesis methods and process optimization have increased yields, reduced costs, and enhanced quality consistency.
• Environmental and Ethical Standards: Growing emphasis on sustainable manufacturing and responsible sourcing influences supplier selection and contractual stipulations.

Conclusion

The landscape for chlorpromazine hydrochloride suppliers is characterized by diversified regional hubs, primarily India and China, complemented by high-quality European manufacturers. Business decisions surrounding procurement hinge on a balance of quality, regulatory compliance, supply reliability, and cost. As global demand persists, ongoing developments in manufacturing technology, regulatory harmonization, and supply chain resilience will shape the supplier ecosystem.

Key Takeaways

• India and China are the dominant suppliers of chlorpromazine hydrochloride, offering high-volume, cost-effective options.
• European suppliers prioritize quality and regulatory compliance, suitable for markets with stringent standards.
• Supply chain resilience depends on diversified sourcing, robust logistics, and understanding geopolitical considerations.
• Regulatory compliance and quality assurance are non-negotiable; suppliers must meet international GMP standards.
• Emerging trends favor technological innovations and sustainable practices, influencing future supplier evaluations.

FAQs

1. Who are the top global suppliers of chlorpromazine hydrochloride?

Major suppliers include Indian companies such as Sun Pharmaceutical Industries and IPCA Labs, Chinese firms like Zhejiang Huahai Pharmaceutical, and European manufacturers like Merck KGaA. These organizations possess established GMP-certified manufacturing capacity aimed at international markets.

2. What should pharmaceutical companies consider when selecting a chlorpromazine hydrochloride supplier?

Companies should prioritize GMP compliance, consistent quality, reliable supply chains, cost-effectiveness, and adherence to international standards. Regulatory credentials and past audit performance are equally critical.

3. Are imported chlorpromazine hydrochloride APIs compliant with US and EU regulations?

Yes, suppliers importing into the US and EU must adhere to FDA and EMA standards, respectively. Certification such as GMP audits and quality testing reports ensure compliance.

4. How has the COVID-19 pandemic impacted chlorpromazine hydrochloride supply chains?

Pandemic disruptions prompted diversification of sourcing regions, increased inventories, and highlighted vulnerabilities in logistics. Suppliers with diversified production facilities and flexible supply chains proved more resilient.

5. Is chlorpromazine hydrochloride synthesis a complex process?

Yes, the manufacturing process involves sophisticated chemical synthesis, requiring high-purity intermediates, stringent quality controls, and specialized expertise to ensure purity and efficacy in the final API.

References

1. [1] "Global API Market Analysis," Pharmaceutical Technology, 2022.
2. [2] "Indian Pharmaceutical Industry Overview," Indian Department of Pharmaceuticals, 2023.
3. [3] "Chinese API Industry Review," China Pharmaceutical Industry Association, 2022.
4. [4] "European API Manufacturers," European Federation of Pharmaceutical Industries and Associations, 2023.
5. [5] "Regulatory Standards for APIs," WHO GMP Guidelines, 2022.