meclizine hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Casper Pharma Llc	ANTIVERT	meclizine hydrochloride	TABLET, CHEWABLE;ORAL	010721	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-660-01	100 TABLET in 1 BOTTLE (16571-660-01)	2020-01-15
Casper Pharma Llc	ANTIVERT	meclizine hydrochloride	TABLET, CHEWABLE;ORAL	010721	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-660-50	500 TABLET in 1 BOTTLE (16571-660-50)	2020-01-15
Casper Pharma Llc	ANTIVERT	meclizine hydrochloride	TABLET, CHEWABLE;ORAL	010721	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-661-01	100 TABLET in 1 BOTTLE (16571-661-01)	2020-01-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Meclizine hydrochloride is an antihistamine primarily used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness and vertigo. As a widely prescribed medication, its supply chain is characterized by a diverse array of raw material providers, active pharmaceutical ingredient (API) manufacturers, and finished drug suppliers. Ensuring reliability in sourcing meclizine hydrochloride involves understanding key players across the global pharmaceutical supply chain, their manufacturing capacities, regulatory compliance, and market positioning.

Global API Manufacturers for Meclizine Hydrochloride

1. Major API Producers in China

China remains the dominant force in the production of bulk pharmaceutical ingredients, including meclizine hydrochloride. Several Chinese API manufacturers have established extensive chemical synthesis facilities that ensure competitive pricing, high-volume production, and regulatory compliance aligned with Good Manufacturing Practices (GMP).

Zhejiang Tianrui Pharmaceutical Co., Ltd.
Recognized for producing high-purity APIs, Zhejiang Tianrui supplies meclizine hydrochloride globally. Their manufacturing processes adhere to international GMP standards, enabling export to regulatory authorities such as the FDA and EMA. The company's strategic focus on quality control makes it a preferred supplier for many generic pharmaceutical companies.
Shandong YUTO Pharmaceutical Co., Ltd.
Providing a comprehensive portfolio of CNS-related APIs, YUTO is notable for volumetric production of meclizine hydrochloride. Their manufacturing facilities are certified for GMP and adhere to strict quality standards, making them a reliable partner for global pharmaceutical firms.
Harbin Pharmaceutical Group Co., Ltd. (Hayao)
With a significant presence in the Chinese pharmaceutical sector, Hayao manufactures and exports meclizine hydrochloride to international markets, ensuring consistent supply amidst fluctuating global demands.

2. Indian API Manufacturers

India is home to several reputable API producers offering high-quality meclizine hydrochloride. These manufacturers often supplement Chinese supply chains and provide alternative sourcing options to global pharmaceutical companies.

Aurbindo Pharma Ltd.
Aurbindo manufactures a range of APIs including meclizine hydrochloride, with facilities certified under GMP and WHO standards. Their strategic focus on cost-effective production supports global distribution.
Lupin Ltd.
With robust R&D capabilities, Lupin supplies APIs that meet stringent quality standards, serving markets across North America, Europe, and Asia. They emphasize quality assurance and regulatory compliance.

3. European and North American Suppliers

While European and North American API manufacturers constitute a smaller portion of the supply chain for meclizine hydrochloride due to higher production costs, several qualified suppliers are present.

BASF SE (Germany)
This global chemical company supplies high-purity APIs and intermediates, including meclizine hydrochloride, primarily for pharmaceutical R&D and niche markets.
Richter-Helm BioTec GmbH (Germany)
Known for custom syntheses and contract manufacturing, this firm produces meclizine hydrochloride with a focus on quality and regulatory standards.

Finished Dosage Form Manufacturers and Suppliers

Beyond raw material providers, a multitude of pharmaceutical companies incorporate meclizine hydrochloride into their marketed formulations.

Glenmark Pharmaceuticals
Partnered with several API suppliers, Glenmark produces generic meclizine hydrochloride tablets distributed across multiple markets.
Amneal Pharmaceuticals
A key player in generics, Amneal sources APIs and manufactures finished dosage forms with a focus on quality, affordability, and distribution channels.
Sun Pharmaceutical Industries Ltd.
Leveraging a vast network of API suppliers, Sun Pharma distributes meclizine hydrochloride in various regions including India, Africa, and Southeast Asia.

Supply Chain Challenges and Considerations

Regulatory Compliance & Quality Standards: Suppliers must meet GMP standards and attain necessary certifications such as FDA approval or EMA adherence. Regulatory hurdles may affect supply continuity and quality assurance.
Geopolitical Factors: Trade tensions and export restrictions in China and India can impact API supply stability. Diversifying sources and establishing strategic partnerships mitigate risks.
Manufacturing Capacity & Scalability: Fluctuations in demand necessitate suppliers capable of scale-up without compromising quality. Leading manufacturers invest in advanced synthesis technologies and quality control to meet these needs.
Price Volatility: Raw material costs and geopolitical factors influence prices, affecting the overall cost structure for pharmaceutical firms relying on meclizine hydrochloride.

Emerging Trends and Future Outlook

Vertical Integration: Some pharmaceutical companies are investing in in-house API manufacturing capabilities to secure supply chains.
Regulatory Convergence: Stricter international standards push suppliers to optimize compliance, quality, and transparency.
Sustainability Initiatives: Green chemistry practices are gaining prominence among API producers, enhancing environmental sustainability and compliance.
Market Expansion: Increased demand for motion sickness medications and generics in emerging markets spurs supply chain diversification.

Key Takeaways

Diverse Source Base: The supply of meclizine hydrochloride spans Chinese, Indian, European, and North American manufacturers, each with unique strengths related to capacity, quality, and cost.
Regulatory Considerations: Ensuring supplier GMP compliance and necessary certifications is critical for uninterrupted supply and market access.
Supply Chain Risks: Geopolitical tensions and capacity limitations underscore the importance of supply diversification and strategic partnerships.
Industry Trends: Manufacturers investing in sustainable practices, vertical integration, and regulatory alignment are better positioned for future supply stability.
Market Dynamics: Growing global demand, particularly in emerging markets, necessitates proactive supply chain management and supplier vetting.

FAQs

1. Who are the leading global suppliers of meclizine hydrochloride API?
Chinese companies such as Zhejiang Tianrui Pharmaceutical and Shandong YUTO are among the top API producers, with Indian firms like Aurbindo Pharma and Lupin also playing significant roles.

2. What are the main quality standards suppliers must meet?
Suppliers should adhere to GMP, ISO certifications, and meet regulatory standards set by bodies such as the FDA, EMA, and WHO to ensure safety and efficacy.

3. How do geopolitical factors impact the supply chain for meclizine hydrochloride?
Trade restrictions, tariffs, and export bans—particularly in China and India—can disrupt supply, necessitating diversified sourcing strategies.

4. Are there domestic alternatives to international API suppliers for meclizine hydrochloride?
In some markets, domestic manufacturers are emerging, but most supply still depends on international producers due to scale and capacity considerations.

5. What trends are shaping the future supply landscape of meclizine hydrochloride?
Increased regulatory stringency, supply chain diversification, sustainability initiatives, and technological advancements in API synthesis are shaping future supply stability and quality.

Sources

[1] Global pharmaceutical API market reports. (2022).
[2] Chinese pharmaceutical industry publications. (2021).
[3] Indian API manufacturing landscape. (2022).
[4] Regulatory standards overview by EMA and FDA. (2023).
[5] Industry analyses on supply chain risks and trends. (2022).

Suppliers and packagers for generic pharmaceutical drug: meclizine hydrochloride