Bulk Pharmaceutical API Sources for BROMODIPHENHYDRAMINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BROMODIPHENHYDRAMINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		519514
ABI Chem		AC1LASIH
Chembase.cn		162715
Finetech Industry Limited		FT-0663610
BOC Sciences		1808-12-4
AKos Consulting & Solutions		AKOS027382254

Bulk Active Pharmaceutical Ingredient (API) Sources for Bromodiphenhydramine Hydrochloride

Last updated: August 5, 2025

Introduction

Bromodiphenhydramine hydrochloride (BDPH) is a first-generation antihistamine commonly used for allergic conditions, motion sickness, and sleep aid formulations. As a key pharmaceutical ingredient, sourcing high-quality API is critical for manufacturers aiming to ensure product efficacy, safety, and regulatory compliance. This report provides a comprehensive overview of the global sources for bulk bromodiphenhydramine hydrochloride, focusing on reputable suppliers, manufacturing regions, and quality considerations relevant to industry stakeholders.

Overview of Bromodiphenhydramine Hydrochloride

Bromodiphenhydramine hydrochloride, a derivative of diphenhydramine, features bromination on the diphenhydramine molecule, influencing its pharmacological profile. The compound exhibits antihistaminic and sedative effects, leveraging its activity at H1 receptors. The API’s synthesis involves specific chemical processes that necessitate careful quality control to meet pharmacopeial standards such as USP, EP, or JP.

Global API Manufacturing Regions

Major regions involved in the production and supply of bromodiphenhydramine hydrochloride include:

• India: Known as a pharmaceutical manufacturing hub, India manufactures a significant portion of generic APIs, including antihistamines like bromodiphenhydramine.
• China: A dominant player in bulk API production with extensive facilities for chemical synthesis.
• Europe and North America: Home to high-quality manufacturers focusing on advanced quality standards and regulatory compliance, often supplying for research, development, and niche markets.

Leading API Suppliers for Bromodiphenhydramine Hydrochloride

1. Indian Manufacturers

India’s pharmaceutical industry, regulated by the Central Drugs Standard Control Organization (CDSCO), supplies a considerable volume of bromodiphenhydramine hydrochloride:

• Cipla Ltd.: A prominent API producer with ISO-certified facilities, known for generic APIs with strict quality standards.
• Aarti Drugs Ltd.: Offers bromodiphenhydramine hydrochloride APIs with Good Manufacturing Practice (GMP) certification, catering to global markets.
• Chemcon Speciality Chemicals Ltd.: Provides bulk APIs including antihistamines, emphasizing high purity and compliance with pharmacopeial standards.

2. Chinese API Manufacturers

China’s API industry benefits from low production costs and large-scale chemical manufacturing:

• Hubei Hongyuan Pharmaceutical Chemical Co., Ltd.: Specializes in manufacturing pharmaceutical intermediates and APIs, including bromodiphenhydramine hydrochloride.
• Zhejiang Kangquan Pharmaceutical Co., Ltd.: Offers bulk API supply, adhering to international quality standards.

3. European and North American Suppliers

Although less prominent in volume, these suppliers prioritize stringent quality standards:

• Bastille Pharmaceuticals (European): Provides custom synthesis of APIs with cGMP compliance.
• Siegfried AG (Switzerland): Offers high-quality APIs with robust regulatory oversight, primarily serving specialized markets.

Key Criteria for Evaluating API Suppliers

When selecting a supplier for bromodiphenhydramine hydrochloride, consider:

• Regulatory Compliance: Ensure suppliers adhere to GMP, and their APIs meet USP, EP, or JP standards.
• Quality Certifications: ISO, cGMP, and other relevant certifications provide assurance of quality.
• Supply Chain Stability: Evaluate the supplier’s manufacturing capacity and delivery reliability.
• Purity and Potency Testing: Confirm the API’s specifications through batch certificates and laboratory testing.
• Traceability and Documentation: Comprehensive documentation ensures compliance with regulatory audits.

Regulatory Considerations

Manufacturers sourcing bromodiphenhydramine hydrochloride must verify that APIs are compliant with their target markets' pharmacopoeial standards. Variations in impurity profiles, residual solvents, and batch-to-batch consistency are critical parameters. Regulatory agencies may require Certificates of Analysis (CoA), Certificate of Suitability (CEPA), or Drug Master Files (DMF), depending on jurisdiction.

Emerging Trends and Challenges

• Quality Assurance: Increasing emphasis on impurity profiling and purity validation prompts suppliers to enhance manufacturing processes.
• Supply Chain Security: Geopolitical factors and disruptions (e.g., COVID-19) underscore the need for diversified supplier bases.
• Environmental Regulations: Stricter controls around waste disposal and sustainable practices influence manufacturing operations, especially in China and India.

Conclusion

The global supply landscape for bromodiphenhydramine hydrochloride APIs is characterized by a diverse array of manufacturers, predominantly in India and China, combined with high-quality, regulated sources in Europe and North America. For pharmaceutical companies, thorough vetting of suppliers based on regulatory compliance, quality standards, and supply reliability remains essential. Strategic sourcing from reputable manufacturers ensures product consistency, regulatory approval, and ultimate patient safety.

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Key Takeaways

• Indian and Chinese manufacturers dominate the bromodiphenhydramine hydrochloride API market, offering cost-effective bulk supply.
• Regulatory compliance, including GMP adherence and pharmacopeial standards, is critical when choosing an API supplier.
• Diversification of sources mitigates supply chain risks amid geopolitical and logistical challenges.
• Quality assurance should include detailed testing and documentation, ensuring impurity profiles meet stringent standards.
• Emerging trends highlight increasing oversight for environmental practices, and a focus on continuous process improvements.

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FAQs

Q1: What are the main considerations when sourcing bromodiphenhydramine hydrochloride API?
Regulatory compliance, API purity, consistent supply, certifications (GMP, ISO), and supplier reputation are paramount.

Q2: Which countries are the predominant producers of bromodiphenhydramine hydrochloride?
India, China, and to a lesser extent, Europe and North America.

Q3: How can I verify the quality of an API supplier?
Review Certificates of Analysis, seek third-party audits, confirm GMP certification, and analyze batch testing results.

Q4: Are there any specific regulatory agencies overseeing bromodiphenhydramine hydrochloride API?
Regulatory oversight varies by region; the US FDA (via USP standards), the European Medicines Agency (EMA), and national agencies enforce compliance.

Q5: What are future trends impacting bromodiphenhydramine hydrochloride API sourcing?
Growing emphasis on quality assurance, supply chain diversification, sustainable manufacturing practices, and regulatory harmonization.

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Sources:
[1] U.S. Pharmacopeia (USP) Monograph for Bromodiphenhydramine Hydrochloride.
[2] Indian Pharmaceutical Gazette, 2022.
[3] Chinese Pharmacopoeia.
[4] Industry reports on API manufacturing and supply chain dynamics.