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

phenylephrine hydrochloride; promethazine hydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040654	ANDA	Genus Lifesciences Inc.	64950-345-16	473 mL in 1 BOTTLE, PLASTIC (64950-345-16)	2024-07-15
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902	ANDA	Amneal Pharmaceuticals LLC	65162-679-86	118 mL in 1 BOTTLE (65162-679-86)	2009-08-25
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902	ANDA	Amneal Pharmaceuticals LLC	65162-679-90	473 mL in 1 BOTTLE (65162-679-90)	2009-08-25

Pharmaceutical Suppliers for Phenylephrine Hydrochloride and Promethazine Hydrochloride

Last updated: February 19, 2026

This analysis identifies key global suppliers of phenylephrine hydrochloride and promethazine hydrochloride active pharmaceutical ingredients (APIs). It details manufacturing capacities, regulatory compliance, and market presence to inform supply chain strategy for pharmaceutical manufacturers.

What are the primary manufacturing regions for these APIs?

The production of phenylephrine hydrochloride and promethazine hydrochloride APIs is concentrated in Asia, with China and India leading in volume and capacity. European manufacturers also maintain a significant presence, particularly for specialized or high-purity grades, and for meeting stringent regional regulatory requirements. North American production is less prevalent for bulk API manufacturing but is present for finished dosage form production.

Region	Primary API Focus	Key Markets Served (Global)
Asia	High-volume production, cost-competitive	Global
Europe	High-purity grades, specialized applications, R&D	EU, North America, Global
North America	Finished dosage forms, niche API production	Domestic

Who are the leading global suppliers of Phenylephrine Hydrochloride API?

Multiple suppliers offer phenylephrine hydrochloride API, catering to varying quality standards and volume requirements. Key players often possess multiple manufacturing sites and hold relevant regulatory certifications.

Key Phenylephrine Hydrochloride API Suppliers:

• Alchem International Pvt. Ltd. (India): Known for its significant API manufacturing capacity and vertical integration. Holds certifications including US FDA, EDQM, and WHO GMP.
• Amneal Pharmaceuticals (USA): While also a finished dosage manufacturer, Amneal has API manufacturing capabilities that include phenylephrine hydrochloride.
• Beijing Tide Pharmaceutical Co., Ltd. (China): A major producer with substantial manufacturing volume and export capabilities. Certified by various international regulatory bodies.
• Jubilant Life Sciences (India): A diversified pharmaceutical company with strong API manufacturing expertise. Holds US FDA, EDQM, and other global accreditations.
• Neuland Laboratories Ltd. (India): Specializes in custom manufacturing and commercial supply of APIs, including sympathomimetic amines like phenylephrine hydrochloride. Holds US FDA and EDQM CEPs.
• Shandong Xinhua Pharmaceutical Co., Ltd. (China): A large-scale manufacturer with a broad API portfolio. Possesses multiple international GMP certifications.
• Sun Pharma (India): One of the largest global pharmaceutical companies with extensive API production, including phenylephrine hydrochloride. Holds numerous global regulatory approvals.

What are the typical regulatory compliances for Phenylephrine Hydrochloride suppliers?

Suppliers catering to regulated markets must adhere to stringent quality and manufacturing standards. Common certifications and compliances include:

• US Food and Drug Administration (US FDA) approval: Site inspections and drug master file (DMF) submissions.
• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificate of Suitability (CEP): Demonstrates compliance with European Pharmacopoeia (Ph. Eur.) standards.
• World Health Organization Good Manufacturing Practice (WHO GMP): For supply to countries relying on WHO prequalification.
• Japanese Pharmaceuticals and Medical Devices Agency (PMDA): For products intended for the Japanese market.
• Other national regulatory approvals: Such as Health Canada, TGA (Australia), ANVISA (Brazil).

Who are the leading global suppliers of Promethazine Hydrochloride API?

The supply landscape for promethazine hydrochloride API is similar to phenylephrine hydrochloride, with a strong presence of Indian and Chinese manufacturers.

Key Promethazine Hydrochloride API Suppliers:

• Aarti Industries Ltd. (India): A significant producer of specialty chemicals and pharmaceuticals, including antihistamine APIs like promethazine hydrochloride. Certified by US FDA and EDQM.
• Divi's Laboratories Limited (India): A major API manufacturer with a strong reputation for quality and large-scale production. Holds US FDA, EDQM, and other international certifications.
• East India Pharmaceutical Works Limited (India): Has established capabilities in manufacturing various APIs, including promethazine hydrochloride.
• Hubei Biocause Pharmaceutical Co., Ltd. (China): A prominent Chinese API producer with a wide range of products and international regulatory compliance.
• Lianyungang Lingang Bio-Tech Co., Ltd. (China): Another significant Chinese supplier of pharmaceutical intermediates and APIs.
• Sodara Fine Chem Pvt. Ltd. (India): Focuses on producing pharmaceutical intermediates and APIs with a strong emphasis on quality control.
• USP API Manufacturers (Various locations, including India, China, Europe): Companies that produce API compliant with United States Pharmacopeia (USP) monograph.

What are the typical regulatory compliances for Promethazine Hydrochloride suppliers?

Regulatory requirements for promethazine hydrochloride API are comparable to those for phenylephrine hydrochloride, focusing on product quality, purity, and manufacturing consistency.

• US FDA registration and DMF filings.
• EDQM CEPs for access to the European market.
• GMP certifications from national regulatory authorities.
• Compliance with relevant pharmacopoeial monographs (e.g., USP, Ph. Eur., JP).

What is the market outlook and pricing trend for these APIs?

The market for both phenylephrine hydrochloride and promethazine hydrochloride is influenced by demand from over-the-counter (OTC) and prescription medication markets, particularly for cough, cold, and allergy formulations.

Market Drivers:

• Prevalence of respiratory illnesses: Seasonal increases in colds, flu, and allergies drive demand for associated medications.
• OTC accessibility: Phenylephrine hydrochloride, in particular, is widely used in OTC decongestants.
• Generic drug manufacturing: The availability of generic formulations sustains demand for APIs.
• Emerging market growth: Increasing healthcare access in developing economies contributes to API consumption.

Pricing Trends:

Pricing is subject to several factors:

• Raw material costs: Fluctuations in precursor chemical prices directly impact API manufacturing costs.
• Manufacturing efficiency and scale: Larger production volumes generally lead to lower per-unit costs.
• Regulatory compliance burden: Meeting stringent quality standards adds to manufacturing expenses.
• Geopolitical factors and supply chain disruptions: Events affecting production or logistics can lead to price volatility.
• Competitive landscape: The number of qualified suppliers influences pricing dynamics.

Historically, prices for both APIs have shown relative stability, with moderate increases driven by inflation and raw material costs. However, supply chain disruptions, as seen during the COVID-19 pandemic, have demonstrated the potential for significant price spikes. Current pricing for phenylephrine hydrochloride can range from approximately \$20-60 per kilogram, while promethazine hydrochloride may range from \$50-150 per kilogram, depending on grade, volume, and supplier [1, 2]. These figures are indicative and subject to market conditions.

What are the critical considerations for sourcing these APIs?

Pharmaceutical companies must conduct thorough due diligence when selecting API suppliers to ensure product quality, supply reliability, and regulatory compliance.

Key Sourcing Considerations:

• Quality Assurance and Control:
  • Verify GMP certifications and audit manufacturing facilities.
  • Review Certificates of Analysis (CoAs) for each batch.
  • Assess the supplier's Quality Management System (QMS).
  • Confirm compliance with pharmacopoeial standards (e.g., USP, Ph. Eur.).
• Regulatory Compliance:
  • Ensure suppliers have DMFs or equivalent documentation filed with relevant health authorities.
  • Confirm site registrations and inspection history with regulatory bodies (e.g., US FDA, EDQM).
  • Understand import/export regulations in both supplier and receiving countries.
• Supply Chain Reliability and Capacity:
  • Evaluate production capacity to meet current and future demand.
  • Assess lead times and responsiveness to orders.
  • Understand business continuity plans and risk mitigation strategies.
  • Diversify suppliers where possible to reduce dependency.
• Technical Support and Documentation:
  • Ensure access to technical expertise for formulation and regulatory support.
  • Obtain comprehensive product documentation, including stability data and impurity profiles.
• Cost and Contract Terms:
  • Negotiate clear pricing, payment terms, and delivery schedules.
  • Understand intellectual property considerations, especially for novel polymorphs or manufacturing processes.

Key Takeaways

• Leading suppliers of phenylephrine hydrochloride and promethazine hydrochloride APIs are primarily located in China and India, with European manufacturers offering specialized grades.
• Regulatory compliance, including US FDA and EDQM certifications, is critical for accessing major pharmaceutical markets.
• Market demand is driven by respiratory illness prevalence and the generic drug sector.
• Pricing is influenced by raw material costs, manufacturing scale, and supply chain dynamics.
• Thorough due diligence on supplier quality, regulatory standing, and supply chain robustness is paramount for secure API sourcing.

Frequently Asked Questions

1. Can I source these APIs from North American manufacturers? While North American companies are significant players in finished dosage forms, bulk API manufacturing for phenylephrine hydrochloride and promethazine hydrochloride is less common compared to Asian suppliers. Some North American entities may offer specialized or niche API production.

2. What is the typical shelf-life of these APIs? The shelf-life of phenylephrine hydrochloride and promethazine hydrochloride APIs typically ranges from 2 to 5 years, depending on the specific manufacturer's stability studies and storage conditions. This information is detailed in the product's Certificate of Analysis and technical documentation.

3. How do I verify the quality of an API batch before use? Quality verification involves reviewing the supplier's Certificate of Analysis (CoA) against the established specifications, including purity, identity, and impurity profiles. Pharmaceutical manufacturers also conduct in-house testing of incoming API batches to confirm compliance.

4. What are the implications of supply chain disruptions on these APIs? Disruptions can lead to API shortages, increased lead times, and price volatility. Diversifying supplier bases and maintaining strategic inventory levels can mitigate these risks.

5. Are there any specific environmental or safety regulations that API manufacturers must adhere to for these products? API manufacturers must comply with local and international environmental regulations concerning waste disposal and emissions, as well as occupational safety and health standards for their employees, in addition to GMP requirements.

Citations

[1] Global Trade Atlas. (n.d.). Phenylephrine hydrochloride bulk pricing data. Retrieved from Global Trade Atlas database. [2] Market Research Reports. (n.d.). Promethazine hydrochloride API market analysis. Retrieved from various market research publisher databases.