codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963	ANDA	Amneal Pharmaceuticals LLC	65162-694-86	118 mL in 1 BOTTLE (65162-694-86)	2013-11-01
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963	ANDA	Amneal Pharmaceuticals LLC	65162-694-90	473 mL in 1 BOTTLE (65162-694-90)	2013-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The supply chain for pharmaceutical ingredients is a critical aspect of drug manufacturing, affecting product quality, regulatory compliance, and market stability. This article provides a comprehensive overview of key suppliers for three prominent active pharmaceutical ingredients (APIs): Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride. These APIs are widely used in analgesic, decongestant, and antihistamine formulations, respectively. Understanding their sourcing landscape helps pharmaceutical companies navigate procurement, mitigate risks, and ensure regulatory adherence.

Global Manufacturing Landscape for APIs

Global API production is concentrated mainly in Asia, with significant contributions from countries such as India, China, and to a lesser extent, in Europe and North America. These regions feature a combination of large-scale manufacturing facilities, many of which are WHO-GMP certified, and smaller specialized producers. Suppliers must meet stringent quality standards, including Good Manufacturing Practices (GMP) and regulatory approvals from agencies such as the FDA and EMA.

Suppliers of Codeine Phosphate

1. Major Manufacturers and Suppliers

Sun Pharmaceutical Industries Ltd. (India): A leading producer of APIs, Sun Pharma supplies pharmaceutical-grade Codeine Phosphate to global markets. Their facilities are GMP-certified, and the company maintains extensive certifications to meet international regulatory standards.
Hubei Yiling Pharmaceutical Co., Ltd. (China): A prominent Chinese API supplier with a broad portfolio, including Codeine Phosphate. Their products are widely used in both branded and generic formulations across Asia, Africa, and emerging markets.
Macleods Pharmaceuticals (India): Known for its robust API manufacturing, Macleods supplies Codeine Phosphate to numerous international clients, adhering to rigorous quality and safety standards.
Jiangxi Qingfeng Pharmaceutical Co., Ltd. (China): Specializing in opioid APIs, Jiangxi Qingfeng offers Codeine derivatives with a focus on compliance and quality controls.

2. Regulatory and Quality Considerations

Codeine is a controlled substance due to its potential for abuse, requiring suppliers to comply with international drug control treaties and local regulations. Companies like Sun Pharma and Hubei Yiling are certified for compliance with international standards, including inspections by regulatory bodies such as the US FDA and EMA.

Suppliers of Phenylephrine Hydrochloride

1. Leading Manufacturers and Distributors

Jubilant HollisterStier LLC (USA): A prominent supplier of pharmaceutical ingredients, including Phenylephrine Hydrochloride, with a focus on high-quality APIs suitable for global markets.
Hubei Buchang Pharmaceutical Co., Ltd. (China): Offers Phenylephrine Hydrochloride produced under GMP standards, exported broadly to North America, Asia, and Europe.
Shandong Xinhua Pharmaceutical Co., Ltd. (China): Manufactures a wide range of decongestants, including Phenylephrine Hydrochloride, with validated manufacturing processes aligned with international quality benchmarks.
Xinjiang Tianshan Pharmaceutical Co., Ltd. (China): Provides Phenylephrine Hydrochloride with a focus on high purity and compliance with pharmacopeial standards.

2. Market Dynamics and Regulatory Status

Phenylephrine is classified as a decongestant and is often used in over-the-counter (OTC) and prescription-grade formulations. Suppliers such as Jubilant HollisterStier have established reputations for quality and consistent supply, vital for compliance with regulatory authorities like the FDA and Health Canada.

Suppliers of Promethazine Hydrochloride

1. Notable Manufacturers

Doras Pharmaceuticals (India): A key API producer for promethazine hydrochloride, supplying pharmaceutical companies globally, with adherence to GMP and international quality standards.
Yifan Pharmaceutical Co., Ltd. (China): Recognized for its high-purity Promethazine Hydrochloride, serving markets across Asia, Europe, and Latin America.
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China): Offers Promethazine Hydrochloride with rigorous quality control measures, ensuring regulatory compliance.
Hubei First Pharmaceutical Group Co., Ltd. (China): Provides a consistent supply of promethazine APIs for generic and branded formulations.

2. Regulatory Assurance

Promethazine is a prescription drug with specific regulatory oversight in various jurisdictions. Suppliers must comply with pharmacopoeial standards (USP, EP) and hold necessary certifications for export to regulated markets.

Key Considerations When Sourcing APIs

Regulatory Compliance: Manufacturers must have validation, GMP certification, and possession of relevant drug master files (DMFs). Suppliers with established regulatory approvals facilitate faster registration and market access.
Quality Assurance: Incoming APIs should be accompanied by Certificates of Analysis (CoA), stability data, and in certain cases, batch-specific test reports to ensure suitability for pharmaceutical production.
Supply Chain Reliability: Geographic diversification reduces risk. Engaging suppliers with large capacities and diverse manufacturing sites can help mitigate shortages arising from geopolitical tensions, natural disasters, or regulatory inspections.
Pricing and Contract Terms: Competitive pricing must be balanced with quality assurances. Long-term relationships and flexible contract terms underpin supply security.

Emerging Trends and Challenges

Regulatory Harmonization: Efforts such as the ICH guidelines aim to standardize quality requirements, simplifying qualification processes for international suppliers.
Supply Chain Transparency: Increasing focus on supply chain due diligence is driven by regulations like the US Drug Supply Chain Security Act (DSCSA), requiring traceability of APIs.
Environmental and Sustainability Standards: Suppliers are under pressure to adopt greener manufacturing processes, which could influence sourcing decisions.
Counterfeit and Substandard APIs: The proliferation of unverified suppliers underscores the importance of rigorous supplier qualification and ongoing quality audits.

Conclusion

Securing reliable suppliers for Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride requires due diligence. Leading global suppliers, primarily based in India and China, uphold specifications aligned with international standards—optimal for pharmaceutical quality and regulatory compliance. Strategic diversification, rigorous quality assurance, and compliance monitoring remain essential components of an effective sourcing strategy amid evolving regulatory landscapes and market dynamics.

Key Takeaways

Asia, notably India and China, dominate the manufacturing of these APIs, offering a broad supplier base.
Regulatory compliance, including GMP certification and valid DMFs, is crucial for supplier qualification.
Quality assurance measures such as CoA, stability data, and batch consistency are indispensable.
Diversifying suppliers mitigates risk and ensures supply security amid geopolitical or logistical disruptions.
Ongoing market and regulatory changes necessitate continual supplier evaluation and adaptation.

FAQs

1. Are there alternative suppliers for these APIs outside Asia?
Yes, Europe and North America host a limited number of specialized API manufacturers, but their capacity is generally smaller, and prices are higher. Companies often rely on Asian suppliers for cost-effective bulk sourcing.

2. How can I verify a supplier's regulatory compliance?
Request certifications such as GMP, ISO, and DMFs, and conduct site audits. Regulatory agencies’ databases, such as FDA’s GDUFA or EMA’s certification records, also provide validation.

3. What regulatory considerations apply to sourcing Codeine Phosphate?
Codeine is a controlled substance under international drug control treaties (e.g., UN Single Convention). Suppliers must hold appropriate licenses, and APIs must comply with local regulations governing narcotics.

4. How do quality standards differ between suppliers?
While GMP compliance is a baseline, quality can vary based on manufacturing practices, batch consistency, and adherence to pharmacopeial standards (USP, EP). Third-party audits and analytical testing help differentiate suppliers.

5. What trends influence future API sourcing strategies?
Increased emphasis on supply chain transparency, sustainability, and regulatory harmonization shapes sourcing. Adoption of digital platforms for supplier qualification and real-time monitoring is also expected to grow.

References

World Health Organization (WHO). Good Manufacturing Practices (GMP) for Pharmaceutical Products.
U.S. Food and Drug Administration (FDA). Drugs@FDA: Database of FDA-approved drugs.
International Conference on Harmonisation (ICH). Pharmaceutical Quality System - Q10 [online].
European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
Industry reports and public disclosures from Sun Pharma, Hubei Yiling, Jubilant HollisterStier, and other leading API manufacturers.

Suppliers and packagers for generic pharmaceutical drug: codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride