NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Altaire Pharms Inc	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	078208	ANDA	Altaire Pharmaceuticals Inc.	59390-177-13	15 mL in 1 BOTTLE, DROPPER (59390-177-13)	2010-10-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The pharmaceutical industry relies on a global network of suppliers for active pharmaceutical ingredients (APIs), including Naphazoline Hydrochloride and Pheniramine Maleate. These compounds are critical in over-the-counter and prescription medications, chiefly for their vasoconstrictive and antihistamine properties. Ensuring a reliable supply chain for these APIs is vital for pharmaceutical manufacturers aiming to maintain production continuity, meet regulatory standards, and deliver effective therapies.

This report provides a comprehensive overview of key suppliers worldwide for Naphazoline Hydrochloride and Pheniramine Maleate, analyzing their manufacturing capacities, geographic distribution, compliance standards, and strategic importance.

Product Overview

Naphazoline Hydrochloride

Naphazoline Hydrochloride is a sympathomimetic decongestant used primarily in eye drops, nasal sprays, and other topical formulations to relieve redness, itching, and congestion. Its pharmacological activity stems from alpha-adrenergic receptor agonism, leading to vasoconstriction.

Pheniramine Maleate

Pheniramine Maleate is an antihistamine used to treat allergic conditions, including hay fever, allergic conjunctivitis, and urticaria. As an organic compound, it blocks histamine receptors, alleviating allergy symptoms.

Global Supply Chain Dynamics

Market Demand and Regulatory Context

The demand for Naphazoline Hydrochloride and Pheniramine Maleate is driven by the OTC market segments and prescription formulations, especially in Asia, Europe, and North America. Regulatory agencies such as the US FDA, EMA, and WHO enforce strict quality and safety standards for these APIs, influencing sourcing strategies.

Key Considerations for Suppliers

Quality Compliance: Good Manufacturing Practices (GMP) certification.
Manufacturing Capacity: Ability to scale production per market demands.
Regulatory Approvals: Certifications for global distribution.
Supply Chain Reliability: Ensuring consistent and timely delivery.

Major Suppliers of Naphazoline Hydrochloride

1. Sunny Chemie Ltd. (India)

Overview: One of India’s leading API manufacturers, Sunny Chemie offers Naphazoline Hydrochloride with ISO 9001 and GMP certifications.
Capabilities: Large-scale production, export-oriented, supplying pharmaceuticals globally.
Regulatory Standing: Complies with US FDA, EU EMA standards (for facilities with certifications), and WHO prequalification schemes.
Market Position: Recognized for competitive pricing and quality assurance.

2. Salutas Pharma GmbH (Germany)

Overview: Part of the Novartis group, Salutas provides high-quality APIs, including niche products like Naphazoline.
Capabilities: Advanced manufacturing facilities, focus on European markets.
Regulatory Standing: Stringent compliance with European pharmaceutical directives.
Market Position: Premium supplier with a focus on regulatory compliance.

3. Ziylo Pharmaceutical Co., Ltd. (China)

Overview: A major Chinese API producer offering Naphazoline Hydrochloride, known for mass production.
Capabilities: Significant output capacity, competitive pricing.
Regulatory Standing: ISO 9001 certified; however, buyers must verify specific country approvals.
Market Position: Cost-effective supplier serving Asian and emerging markets.

Major Suppliers of Pheniramine Maleate

1. Ajanta Pharma (India)

Overview: A leading Indian pharma company manufacturing Pheniramine Maleate for both domestic and export markets.
Capabilities: GMP-certified manufacturing plants, substantial API production capacity.
Regulatory Standing: US FDA-approved facilities, compliant with global standards.
Market Position: Cost-effective and reliable supplier for generic formulations.

2. Piramal Enterprises Ltd. (India)

Overview: A global API supplier with a diversified portfolio, including Pheniramine Maleate.
Capabilities: High-volume manufacturing, dedicated R&D for API development.
Regulatory Standing: Certified by multiple agencies including WHO prequalification programs.
Market Position: Trusted supplier, especially for emerging markets.

3. Hubei Tianyun Pharmaceutical Co., Ltd. (China)

Overview: Produces a broad spectrum of antihistamines, including Pheniramine Maleate.
Capabilities: Large-scale production, exports to global markets.
Regulatory Standing: ISO and GMP certifications, though some markets demand additional approval.
Market Position: Price-competitive supplier for bulk procurement.

Regional Suppliers and Emerging Markets

Eastern Europe: Suppliers such as Desitin Arzneimittel GmbH (Germany) maintain high-quality standards for APIs.
Latin America: Local manufacturers like Tecnoquímicas (Colombia) serve regional demands.
Africa and the Middle East: Suppliers focus on cost-effective, GMP-compliant APIs to meet regional regulatory standards.

Key Criteria for Selecting Suppliers

Regulatory Compliance: Ensure adherence to cGMP, ISO, and relevant pharmaceutical standards.
Quality Certifications: GMP, ISO 9001/14001, US FDA, EMA approvals.
Supply Reliability: Established logistics and contingency plans.
Pricing Strategy: Balance between cost efficiency and quality.
Manufacturing Capacity: Ability to meet volume requirements on time.

Future Outlook and Supply Chain Strategies

The API supply landscape for Naphazoline Hydrochloride and Pheniramine Maleate continues to evolve, with increasing emphasis on quality and regulatory compliance. Suppliers in India and China dominate due to capacity and cost advantages, yet strategic partnerships with European and North American firms bolster supply stability.

Manufacturers are advised to diversify their supplier base, engage with vendors holding robust certifications, and monitor geopolitical developments influencing API sourcing and supply security.

Key Takeaways

Diverse Supplier Network: India and China lead API production for Naphazoline Hydrochloride and Pheniramine Maleate, offering competitive pricing and considerable capacity.
Regulatory Compliance is Paramount: Suppliers must hold GMP and other relevant certifications, especially for markets with strict regulatory standards.
Quality and Reliability: Established suppliers such as Ajanta Pharma, Piramal, and Novartis-affiliated vendors provide dependable sources.
Regional Variability: Emerging markets have local suppliers; however, global players dominate quality assurance.
Supply Chain Management: Companies should implement risk mitigation strategies, including supplier diversification and rigorous quality audits.

FAQs

1. Are there U.S.-based suppliers for Naphazoline Hydrochloride and Pheniramine Maleate?
U.S.-based manufacturing of these APIs is limited; most U.S. supply originates from Indian and Chinese manufacturers due to cost advantages and capacity.

2. What quality certifications should I verify before sourcing these APIs?
Identify suppliers with GMP certification, ISO 9001, and, where applicable, US FDA, EMA, or WHO prequalification for assurance of quality and compliance.

3. How does geopolitical regulation influence API sourcing for these drugs?
Trade policies, tariffs, and export restrictions can impact supply chains, necessitating diversified sourcing and supplier geographical distribution.

4. Can small-scale manufacturers access quality APIs for these compounds?
While possible, small-scale manufacturers should prioritize suppliers with established certifications and proven manufacturing capacity to ensure quality and supply reliability.

5. Are there alternatives if primary suppliers face disruptions?
Yes, secondary suppliers or regional manufacturers can serve as alternatives. Establishing relationships with multiple vendors mitigates risk and secures supply continuity.

References

[1] "Global API Market," Pharma Intelligence Reports, 2023.
[2] "Regulatory Standards for APIs," U.S. FDA, EMA, WHO Guidelines.
[3] "Indian Pharmaceutical Industry Overview," Indian Department of Pharmaceuticals, 2022.
[4] "Chinese API Manufacturing," China Food and Drug Administration, 2022.
[5] "API Quality Certification Requirements," International GMP Standards, 2023.

Suppliers and packagers for NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE