Bulk Pharmaceutical API Sources for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C03311
RR Scientific		R6440204

Bulk Active Pharmaceutical Ingredient (API) Sources for Phenylephrine Hydrochloride and Promethazine Hydrochloride

Last updated: November 18, 2025

Introduction

In the pharmaceutical industry, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is foundational for ensuring product efficacy, safety, and regulatory compliance. Phenylephrine hydrochloride and promethazine hydrochloride are pivotal APIs widely utilized in formulations for decongestants, antihistamines, and antiemetics. This article explores global API suppliers, highlighting their manufacturing capabilities, regulatory standing, and market presence to aid pharmaceutical companies in strategic procurement.

Overview of Phenylephrine Hydrochloride and Promethazine Hydrochloride

Phenylephrine Hydrochloride is a sympathomimetic amine primarily employed as a nasal decongestant and vasopressor. Its mechanism involves stimulating alpha-1 adrenergic receptors, leading to vasoconstriction. Given its widespread usage in OTC and prescription formulations, consistent API supply and quality are crucial.

Promethazine Hydrochloride belongs to the phenothiazine class and functions as an antihistamine with antiemetic and sedative properties. Its stability and bioavailability are integral to formulation performance, necessitating reliable API sources compliant with regulatory standards.

Global API Manufacturing Landscape

The API market is dominated by regions with established pharmaceutical manufacturing infrastructure, notably India, China, Europe, and the United States. These regions host numerous qualified bulk API producers with capabilities spanning from synthesis to quality control and regulatory compliance.

1. Leading API Manufacturers for Phenylephrine Hydrochloride

India

• Sandoz (Novartis Group)
  Sandoz operates multiple manufacturing sites in India, offering bulk phenylephrine API with GMP certification. Their APIs comply with international standards, fostering trust among global clients.

• Shilpa Pharmaceutical Ltd.
  This manufacturer supplies phenylephrine hydrochloride API to various markets, with facilities adhering to WHO and cGMP guidelines. They emphasize consistent supply and competitive pricing.

• Hetero Labs Ltd.
  Known for a broad API portfolio, Hetero produces phenylephrine hydrochloride with rigorous quality standards, catering to both domestic and export markets.

China

• North China Pharmaceutical Group Corporation (NCPC)
  NCPC is a major Chinese API producer with extensive capabilities in phenylephrine synthesis, including automated processes aligned with GMP standards.

• Qilu Pharmaceutical
  A prominent Chinese API manufacturer with a focus on high-volume phenylephrine hydrochloride API, emphasizing quality control and regulatory compliance (CFDA approved).

Europe & US

While less prominent in the bulk phenylephrine market, some European and US-based firms like Pfizer and Teva occasionally import API from Asian manufacturers, focusing more on formulation.

2. Leading API Manufacturers for Promethazine Hydrochloride

India

• Aurobindo Pharma
  A leading global API supplier, Aurobindo offers promethazine hydrochloride conforming to international standards, with extensive regulatory approvals.

• Cipla Ltd.
  Cipla produces high-quality promethazine API, maintaining cGMP compliance and offering robust supply chain backing.

• Divi's Laboratories
  Known for synthetic expertise, Divi's supplies promethazine hydrochloride API with a focus on purity and batch consistency.

China

• Hengkang Pharma
  Specializes in phenothiazine derivatives, including promethazine hydrochloride, with GMP certification and competitive pricing.

• Zhejiang Shengda Pharmaceutical
  Provides bulk promethazine hydrochloride API for global markets, emphasizing quality control and regulatory adherence.

Europe & North America

Manufacturers like Viatris and Alphapharm source or produce promethazine API, emphasizing regulatory compliance and traceability, often working under strict pharmaceutical standards.

Critical Factors in API Sourcing

Regulatory Compliance

Manufacturers must maintain certifications like cGMP, ISO, or equivalent standards, ensuring API quality aligns with pharmacopeial monographs (USP, EP, BP).

Quality Control & Purity

High purity levels (typically >99%) and strict impurity profiles are mandatory for APIs used in human medicines. Reliable QC processes and batch consistency are vital.

Supply Chain Stability

Long-term partnerships with manufacturers possessing robust supply chains reduce risks related to shortages, regulatory hiccups, or quality issues.

Pricing & Lead Time

Competitive pricing coupled with responsive delivery timelines influence procurement decisions, especially for APIs with high global demand.

Emerging Trends and Challenges

• Regulatory Divergence: Variations in regulatory requirements across regions pose challenges. Suppliers compliant with multiple jurisdictions are preferable.

• Manufacturing Consolidation: Industry consolidation leads to fewer but larger API producers, impacting market dynamics and pricing.

• Quality Assurance: Increasing emphasis on bioequivalence, process validation, and impurity profiling necessitates stringent supplier qualification.

• Global Disruptions: Pandemics and geopolitical factors may impact supply stability; diversifying supplier base can mitigate risks.

Regulatory and Certification Overview

Most reputable producers possess certifications such as:

• current Good Manufacturing Practices (cGMP)
• ISO 9001 Certification
• Environmental and Safety Standards

API suppliers also typically undergo audits by clients or regulatory agencies, especially for APIs exported to the US, EU, or Japan.

Conclusion

Reliable sourcing of phenylephrine hydrochloride and promethazine hydrochloride APIs hinges on selecting manufacturers with proven quality records, compliance with international standards, and robust supply chains. India and China dominate the manufacturing landscape, offering cost-effective, compliant options. However, pharmaceutical companies must conduct diligent supplier qualification to ensure product integrity, regulatory compliance, and uninterrupted supply.

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Key Takeaways

• India and China are primary sources of phenylephrine and promethazine APIs, supported by extensive manufacturing infrastructure and competitive pricing.
• Regulatory compliance, including cGMP certification and quality control measures, remains critical for API selection.
• Diversification of suppliers and ongoing quality audits mitigate supply chain risks.
• Staying updated on emerging regulatory standards and industry consolidation trends enhances procurement strategies.
• Collaborative relationships with certified API manufacturers can lead to better pricing, consistent quality, and supply reliability.

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FAQs

1. How do I verify the quality of phenylephrine or promethazine APIs from Chinese manufacturers?
Verifying quality involves reviewing regulatory certifications (cGMP, ISO), requesting batch documentation, and conducting third-party audits or inspections to confirm compliance with pharmacopeial standards.

2. Are there European or North American manufacturers supplying these APIs?
While most manufacturing occurs in India and China, European and North American producers often source from these regions or maintain in-house manufacturing. However, direct procurement from these regions is less common due to higher costs.

3. What are the primary regulatory considerations when importing APIs?
Alignment with local regulatory standards (FDA, EMA, CFDA), possessing necessary certifications, and ensuring raw material traceability are essential for compliance and market approval.

4. How can supply chain disruptions be minimized when sourcing APIs?
Establishing multiple supplier relationships, maintaining inventory buffers, and choosing suppliers with validated supply chains help minimize risks.

5. How do I assess the environmental practices of API manufacturers?
Review environmental certifications, conduct supplier audits, and require environmental compliance documentation to ensure sustainable manufacturing practices.

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Sources:

[1] IQVIA, "API Market Analysis," 2022.
[2] U.S. Food and Drug Administration (FDA), "Drugs@FDA" database.
[3] European Medicines Agency (EMA), "Guidelines on API Quality."
[4] Global Industry Analysts Inc., "Active Pharmaceutical Ingredients Market," 2021.
[5] Industry reports from PharmSource and ChemImplement.