ketorolac tromethamine; phenylephrine hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-00	1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-04	4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-99	4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL	2023-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape hinges on a robust supply chain for active pharmaceutical ingredients (APIs) facilitating the production of vital medications. Among these, Ketorolac Tromethamine and Phenylephrine Hydrochloride are prominently used in analgesia and decongestion treatments respectively. This analysis provides an authoritative overview of key suppliers for these APIs, highlighting their geographical distribution, manufacturing capabilities, regulatory standing, and strategic significance for pharmaceutical companies seeking dependable sourcing options.

1. Overview of Ketorolac Tromethamine and Phenylephrine Hydrochloride

Ketorolac Tromethamine: A non-steroidal anti-inflammatory drug (NSAID) primarily used for short-term management of moderate to severe pain. Its high potency and rapid onset make it critical in surgical and emergency settings.

Phenylephrine Hydrochloride: A selective alpha-1 adrenergic receptor agonist employed predominantly as a vasoconstrictor to alleviate nasal congestion and as a mydriatic during ophthalmic procedures. Its widespread use in OTC nasal sprays and injectable formulations underscores the need for a consistent supply.

2. Major Suppliers of Ketorolac Tromethamine

2.1 Leading Global API Manufacturers

Siegfried AG (Germany)
Siegfried has robust capabilities in synthesizing complex APIs, including Ketorolac Tromethamine. The firm maintains high-quality manufacturing standards conforming with GMP (Good Manufacturing Practice) regulations and supplies to a wide network of pharmaceutical clients globally.
Hainan Tianyun Chemical Co., Ltd. (China)
Specializing in NSAIDs, this Chinese manufacturer supplies APIs and intermediates, including Ketorolac Tromethamine, with cost-effective production scales and competitive pricing. The company's regulatory compliance with Chinese GMP standards enhances its regional and international credibility.
Hubei Wufeng Pharmaceutical Co., Ltd. (China)
A notable producer in China, this firm offers APIs for NSAIDs, including Ketorolac Tromethamine, focusing on high purity and consistent batch quality to meet international export requirements.
China-based Large API Producers (e.g., Jiangsu Hott Pharmaceuticals, Zhejiang Huahai Pharmaceutical)
These companies have diversified portfolios that include NSAID APIs like Ketorolac Tromethamine, supported by rigorous quality control systems aligned with international GMP standards.

2.2 Regional Spotlight

North American Suppliers
Although specific North American manufacturers are fewer due to stricter regulatory barriers, companies such as BAS Pharmaceutical (Canada) often source APIs from Chinese manufacturers or produce domestically under strict compliance.
European Suppliers
Besides Siegfried, companies like Pharmaceutica Trovione (Italy) are exploring high-quality synthesis routes but remain secondary to Asian scale producers.

3. Leading Suppliers of Phenylephrine Hydrochloride

3.1 Prominent Global API Manufacturers

Jiangsu Hengrui Medicine Co., Ltd. (China)
A dominant player in the phenylephrine market, Hengrui supplies high-quality Phenylephrine Hydrochloride APIs used in OTC formulations and injectable drugs. Their extensive R&D and manufacturing infrastructure ensure consistent supply and product purity.
Xiamen Sky Myth Chemical Co., Ltd. (China)
Known for phenylephrine and other adrenergic agents, they provide competitively priced API bulk supplies, complying with international quality standards compatible with global markets.
Dr. Reddy’s Laboratories (India)
A notable Indian pharmaceutical company that produces Phenylephrine Hydrochloride API, leveraging India’s manufacturing ecosystem renowned for bulk pharmaceutical ingredients (BPI).
Rare Pharma Corporation (USA)
Specializes in the production and distribution of phenylephrine APIs for specialized medicinal use, including nasal sprays and injectable products, adhering to strict FDA regulations.

3.2 Other Notable Suppliers

Zhejiang Linghuan Pharmaceutical (China)
Offers phenylephrine hydrochloride APIs with a focus on high purity grades suitable for medicinal formulations in global markets.
Sigma-Aldrich (now part of MilliporeSigma, USA)
Supplies high-quality phenylephrine hydrochloride as a research-grade compound, occasionally used in pharmaceutical formulation development.

4. Supplier Selection Considerations

Regulatory Compliance: Suppliers must meet regional GMP, ISO certifications, and regulatory approvals (e.g., FDA, EMA, CFDA). Chinese API manufacturers increasingly align with stringent international standards, fostering greater confidence worldwide.

Manufacturing Capacity and Flexibility: Large-scale production capabilities and the ability to accommodate formulation-specific quality parameters are vital, especially amid supply chain disruptions like those seen during the COVID-19 pandemic.

Quality Assurance and Testing: Certification of analysis (CoA), batch consistency, and stability data underpin supplier reliability, reducing risk in formulation processes.

Pricing and Lead Time: Competitive pricing, balanced with quality and regulatory compliance, remains central. Geographic proximity or regional manufacturing hubs can influence lead times and shipping costs.

5. Strategic Implications for Pharma Companies

Securing trusted suppliers for Ketorolac Tromethamine and Phenylephrine Hydrochloride is crucial to maintaining uninterrupted medication production. The ongoing shift toward China and India as dominant API manufacturing hubs increases supplier diversification but also underscores the importance of rigorous quality audits and compliance verification. Meanwhile, Western firms and contract manufacturing organizations (CMOs) seek partnerships with Chinese and Indian manufacturers to leverage scale and cost advantages without compromising standards.

Key Takeaways

The Chinese pharmaceutical industry dominates the supply of both Ketorolac Tromethamine and Phenylephrine Hydrochloride APIs, particularly through companies like Jiangsu Hengtong Pharmaceutical and Xiamen Sky Myth Chemical.
European and North American suppliers focus on niche high-quality, regulatory-compliant products, often serving specialized markets or fulfilling regulatory requirements for marketing authorization.
Regulatory compliance, manufacturing capacity, quality assurance, and cost competitiveness are essential factors for stakeholders selecting API suppliers.
Diversifying suppliers across geographical regions mitigates risks associated with geopolitical and supply chain disruptions.
Strategic partnerships with reliable API manufacturers underpin consistent supply and facilitate global expansion for pharmaceutical companies.

FAQs

1. Are Chinese manufacturers of Ketorolac Tromethamine and Phenylephrine Hydrochloride compliant with international standards?
Yes. Many Chinese API producers have attained GMP certification and adhere to international regulatory standards like ISO, facilitating export and global acceptance.

2. How can pharmaceutical companies verify supplier quality and compliance?
Through audits, review of regulatory certificates, batch testing, and ongoing quality assurance programs. Engaging third-party inspectors and certification bodies adds additional verification layers.

3. What risks are associated with sourcing APIs from Asia?
Potential risks include regulatory non-compliance, quality variability, intellectual property concerns, and geopolitical factors impacting supply chains. Mitigation strategies involve supplier audits, quality agreements, and diversification.

4. Is there a trend toward local manufacturing for these APIs?
Increasingly, Western countries aim to bolster domestic API production to reduce dependency on Asian suppliers, driven by safety, quality, and supply chain resilience concerns.

5. How do prices influence the choice of API suppliers?
Pricing remains a key factor, especially for large-volume production. However, cost savings must be balanced against quality and regulatory compliance to avoid supply disruptions and compliance issues.

Suppliers and packagers for generic pharmaceutical drug: ketorolac tromethamine; phenylephrine hydrochloride