PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE bulk active fine chemical vendors

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Last updated: October 13, 2025

Introduction

In the pharmaceutical supply chain, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is fundamental to ensuring drug safety, efficacy, and regulatory compliance. This is especially critical for well-established compounds like Promethazine Hydrochloride and Phenylephrine Hydrochloride, used extensively in antihistamine, antiemetic, and decongestant formulations. The global API market for these compounds features a diverse array of suppliers—ranging from large-scale manufacturers in India and China to specialized chemical producers across Europe and North America.

This analysis provides a comprehensive overview of credible bulk API sources for Promethazine Hydrochloride and Phenylephrine Hydrochloride, emphasizing sourcing reliability, manufacturing standards, and geographic distribution.

Global Market Overview of API Suppliers

The API manufacturing landscape is predominantly dominated by India and China, together accounting for over 70% of global production for many essential compounds. Both regions host extensive APIs manufacturing hubs that comply with international quality standards such as WHO GMP, USFDA, and EMA certifications.

European and North American manufacturers comprise niche producers often serving high-specification, regulated markets. They typically maintain rigorous quality assurance regimes, licensing, and compliance frameworks.

Bulk API Sources for Promethazine Hydrochloride

1. Indian Manufacturers

Hetero Drugs Ltd.
Hetero is a leading API producer with WHO-GMP accreditation. Their Promethazine Hydrochloride API is widely supplied to various markets, including North America, Europe, and Africa. The company's scaling capabilities and quality standards make them a preferred choice for bulk procurement.
Aurobindo Pharma Ltd.
Aurobindo offers high-quality Promethazine Hydrochloride APIs, with ISO certification and robust supply chain logistics. Their production facilities are compliant with cGMP norms, ensuring product consistency and purity.
Synthesis and Specialty Chemical Producers
Numerous smaller Indian firms manufacture Promethazine Hydrochloride, catering primarily to regional or custom pharmaceutical formulations. Examples include IPCA Laboratories and Natco Pharma, both with certifications aligning with global regulatory agencies.

2. Chinese API Manufacturers

Shanghai Fosun Pharmaceutical Co., Ltd.
Fosun manufactures Promethazine Hydrochloride with a focus on global exports. Their API complies with international quality standards, supported by rigorous internal quality management systems.
Hainan Zhonghe Pharmaceutical Co., Ltd.
This firm supplies bulk Promethazine Hydrochloride, often catering to generic pharmaceutical companies across Asia and beyond.

3. European and North American Suppliers

While less prevalent, certain European and North American companies produce Promethazine Hydrochloride APIs for specialized or high-purity needs:

Bachem AG (Switzerland)
Bachem supplies custom and bulk APIs, including Promethazine Hydrochloride, primarily serving clinical and specialty sectors.
TEVA Pharmaceutical Industries Ltd.
TEVA's manufacturing facilities in Israel and the Czech Republic produce multiple APIs, including Promethazine Hydrochloride, adhering to cGMP standards.

Bulk API Sources for Phenylephrine Hydrochloride

1. Indian API Producers

Biological E. Limited
A significant supplier with certified manufacturing facilities. They produce Phenylephrine Hydrochloride with adherence to WHO GMP standards, exporting globally.
Granules India Ltd.
Recognized for its manufacturing excellence, Granules India supplies high-purity Phenylephrine Hydrochloride, emphasizing cost-effective bulk sourcing.
Divi's Laboratories
Divi's offers high-quality Phenylephrine Hydrochloride APIs with comprehensive certifications aligning with international regulators.

2. Chinese API Manufacturers

Qilu Pharmaceuticals
A reputable manufacturer of Phenylephrine Hydrochloride, Qilu complies with international standards and supplies to major pharmaceutical companies worldwide.
North China Pharmaceutical Group Corporation (NCPC)
An established producer of various decongestants, including Phenylephrine Hydrochloride, serving Asian and international clients.

3. European and American Sources

Jubilant Cadista Pharmaceuticals (USA)
Specializes in generic APIs, including Phenylephrine Hydrochloride, with finished product manufacturing capabilities compliant with U.S. FDA regulations.
BASF SE (Germany)
Engages in specialty chemical manufacturing, with certain flagship APIs produced at high purity levels for regulated markets.

Criteria for Selecting API Suppliers

When sourcing Promethazine Hydrochloride and Phenylephrine Hydrochloride APIs, pharmaceutical companies should prioritize:

Regulatory Certification: Ensure suppliers hold valid GMP, WHO-GMP, USFDA, or EMA approvals.
Supply Chain Transparency: Verify capacity, lead times, and quality control protocols.
Product Purity and Specification: Confirm API specifications meet pharmacopoeial standards (USP, EP, BP).
Reputation and Reliability: Consider long-standing supplier relationships and references.
Pricing and Terms: Negotiate with suppliers offering competitive pricing without compromising quality standards.

Regulatory Considerations

Sourcing APIs for medications involves strict adherence to regulatory frameworks. Companies must validate that API batch documentation, stability data, and manufacturing practices comply with local and international regulations. Registration in global databases such as the ICH Q7 guidelines is advisable.

Regional Trends and Future Outlook

The API market for Promethazine Hydrochloride and Phenylephrine Hydrochloride remains stable, driven by their widespread use in OTC and prescription products. The increasing emphasis on quality assurance and supply chain transparency has propelled diversified sourcing into regions beyond Asia, including North America and Europe. The ongoing trend toward lower regulatory barriers in certain manufacturing sectors may influence future sourcing strategies.

Key Takeaways

Indian and Chinese APIs dominate the bulk supply of Promethazine Hydrochloride and Phenylephrine Hydrochloride owing to cost-effectiveness and manufacturing capacity.
European and North American suppliers often cater to niche or high-quality segments, emphasizing regulatory compliance.
Due diligence in assessing certification, quality standards, and supply reliability is essential for procurement.
Evolving regulations and supply chain transparency are shaping sourcing strategies toward diversification and rigorous validation.
Maintaining good supplier relationships aligned with quality and compliance standards mitigates risks and ensures steady supply.

FAQs

1. Are Indian and Chinese API suppliers compliant with international quality standards?
Yes, reputable Indian and Chinese API manufacturers often hold certifications such as WHO-GMP, USFDA, or EMA, ensuring compliance with international quality and manufacturing standards.

2. How can I verify the quality of APIs from a supplier?
Request certification documents, batch manufacturing records, and certificate of analysis (CoA). Additionally, conducting periodic audits and third-party testing further verifies API quality.

3. What are the advantages of sourcing APIs from European or North American manufacturers?
These suppliers typically adhere to stricter regulatory standards, providing higher assurance of purity, consistent quality, and traceability—especially important for regulated markets.

4. Is there a significant quality difference between APIs sourced from India/China versus Europe/US?
While high-quality APIs are available from all regions, European and US manufacturers usually maintain more rigorous quality control due to stricter regulatory frameworks. Indian and Chinese APIs can match European/US quality when sourced from reputable, certified suppliers.

5. What emerging trends are influencing API sourcing for these compounds?
Increased transparency, supply chain security, and regulatory harmonization are influencing sourcing decisions. Investment in advanced manufacturing technologies and quality systems is also growing to meet global demand for high-purity APIs.

References

[1] "Global API Market Overview," IQVIA Institute, 2022.
[2] "Quality Standards for API Manufacturing," WHO Guidelines, 2019.
[3] "Top API Manufacturers in India," PharmaIQ, 2022.
[4] "API Supply Chains in China," Chinese Pharmaceutical Journal, 2021.
[5] "European API Industry Report," EFPIA/European Commission, 2020.

Bulk Pharmaceutical API Sources for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE