Suppliers and packagers for generic pharmaceutical drug: SULFACETAMIDE SODIUM

SULFACETAMIDE SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	KLARON	sulfacetamide sodium	LOTION;TOPICAL	019931	NDA	Bausch Health US, LLC	0187-5198-04	1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC	1996-12-23
Bausch	KLARON	sulfacetamide sodium	LOTION;TOPICAL	019931	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-010-04	1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) / 118 mL in 1 BOTTLE, PLASTIC	2015-12-18
Padagis Us	SULFACETAMIDE SODIUM	sulfacetamide sodium	LOTION;TOPICAL	078649	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-896-26	118 mL in 1 BOTTLE, PLASTIC (45802-896-26)	2012-10-17
Padagis Us	SULFACETAMIDE SODIUM	sulfacetamide sodium	OINTMENT;OPHTHALMIC	080029	ANDA	Padagis US LLC	0574-4190-35	1 TUBE in 1 CARTON (0574-4190-35) / 3.5 g in 1 TUBE	2014-08-13

Suppliers for the Pharmaceutical Drug: SULFACETAMIDE SODIUM

Last updated: July 28, 2025

Introduction

Sulfacetamide sodium is a topical sulfonamide antibiotic used primarily in ophthalmology and dermatology to treat bacterial infections. As a crucial component in anti-infective therapy, its manufacturing, sourcing, and supply chain are tightly regulated to ensure quality, safety, and efficacy. This article provides a comprehensive overview of the leading suppliers for sulfacetamide sodium, including key manufacturers, global distribution channels, and market dynamics shaping the supply landscape.

Understanding Sulfacetamide Sodium

Sulfacetamide sodium functions as a bacteriostatic agent that inhibits bacterial folic acid synthesis. Historically employed in ophthalmic solutions and topical creams, its applications extend to treating conjunctivitis, blepharitis, and acne vulgaris. Given its widespread medical use, reliable sourcing from reputable manufacturers is essential for healthcare providers and pharmaceutical companies.

Major Suppliers of Sulfacetamide Sodium

1. Global Pharmaceutical Ingredient Manufacturers

Several pharmaceutical ingredient (API) producers dominate the vacuum of sulfacetamide sodium supplies. These manufacturers comply with Good Manufacturing Practices (GMP) and are certified by major regulatory bodies such as the FDA (USA), EMA (Europe), and other national agencies.

a. Jiangsu Sinomed Pharmaceutical Co., Ltd. (China)

One of the leading Chinese API manufacturers, Jiangsu Sinomed supplies high-quality sulfacetamide sodium for export worldwide. Its manufacturing facilities adhere to strict GMP standards, and the company has extensive experience in antibiotic APIs, serving both generic and branded formulations [1].

b. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)

Hisoar is recognized for its specialty pharmaceutical compounds, including sulfacetamide sodium. The company emphasizes quality assurance and has achieved multiple international certifications, supplying both bulk API and finished pharmaceutical formulations [2].

c. Vinayak Organics (India)

Vinayak Organics, based in India, specializes in synthesizing sulfonamide antibiotics, including sulfacetamide sodium. With ISO certification and a focus on sustainable manufacturing processes, it serves various markets, particularly in Asia and Africa [3].

2. Established Multinational Chemical Suppliers

In addition to regional manufacturers, some multinational chemical corporations supply sulfacetamide sodium to global pharmaceutical markets either directly or via licensing agreements.

a. HanseChem (Germany)

HanseChem offers pharmaceutical-grade sulfacetamide sodium, leveraging its extensive distribution network across Europe, North America, and Asia. The company's APIs meet strict international standards, providing reliable supply to pharma companies [4].

b. Thermo Fisher Scientific (USA)

While primarily a supplier of laboratory reagents, Thermo Fisher occasionally provides custom synthesis services for active pharmaceutical ingredients, including sulfacetamide sodium, primarily for research and development purposes [5].

3. Contract Manufacturing Organizations (CMOs)

Several CMOs globally serve as production hubs for sulfacetamide sodium APIs, enabling pharmaceutical companies to outsource manufacturing.

a. Zhejiang Medicine Co., Ltd. (China)

Zhejiang Medicine is a leading CMO offering flexible production scales for sulfacetamide sodium, with a focus on high purity and consistent quality. Its facilities operate under rigorous quality management systems suitable for WHO-GMP and FDA standards [6].

b. Biocon (India)

Biocon provides custom synthesis and contract manufacturing services for antibiotics, including sulfacetamide sodium, catering to both domestic and international markets with verified GMP compliance [7].

Distribution and Supply Chain Dynamics

The supply chain for sulfacetamide sodium involves multiple stages: from raw material sourcing (sulfone-based intermediates, solvents) to synthesis, purification, formulation, and distribution. Geographical diversification reduces risks associated with regional disruptions.

Regional Supply Concentration

While China and India dominate the sulfacetamide sodium API manufacturing landscape due to cost advantages and mature chemical sectors, Europe and North America primarily function as distribution hubs with strict regulatory oversight.

Regulatory Impact

Regulatory standards significantly impact supplier credibility. Suppliers with WHO-GMP, cGMP, and FDA approval serve as preferred sources for pharmaceutical companies aiming for high-quality, compliant products. Certification facilitates smoother import-export procedures and reduces compliance risks.

Market Trends

Recent trends indicate increasing demand from emerging markets in Africa and Southeast Asia, driven by expanding healthcare infrastructure and generic drug use. This shift stimulates supply chain diversification and encourages new entrants to establish manufacturing facilities.

Key Considerations When Selecting a Supplier

• Regulatory Compliance: GMP certification, quality assurance protocols, and registration status.
• Manufacturing Capacity: Ability to meet current and projected demand volumes.
• Supply Chain Stability: Proven track record in consistent delivery timelines.
• Price Competitiveness: Cost considerations balanced with quality assurance.
• Geopolitical Stability: To mitigate risks associated with regional disruptions.

Future Outlook

The global market for sulfacetamide sodium is expected to grow modestly, driven by increasing ophthalmic and dermatological indications. The supply landscape is also likely to evolve with advances in synthesis technologies, enabling more sustainable and cost-effective production. Emerging manufacturers in Southeast Asia and Africa will likely influence supply diversification and price dynamics.

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Key Takeaways

• Major Producers: Chinese companies like Jiangsu Sinomed and Zhejiang Hisoar dominate API production; Indian firms such as Vinayak Organics and Biocon serve expanding regional markets.

• Supply Chain Risks: Geographic concentration poses risks; diversification enhances security.

• Regulatory Standards: Suppliers with GMP and international certifications remain prioritized choices for pharmaceutical companies seeking compliance.

• Market Demand: Growing use in ophthalmology and dermatology, especially in emerging economies, influences supply landscape dynamics.

• Emerging Trends: Synthesis innovations and new market entrants will shape future supply channels.

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FAQs

1. Which are the leading global suppliers of sulfacetamide sodium?
Chinese manufacturers such as Jiangsu Sinomed and Zhejiang Hisoar are prominent, complemented by Indian firms like Vinayak Organics. European companies like HanseChem also supply pharmaceutical-grade APIs to the international market.

2. What regulatory certifications should suppliers possess?
Suppliers should have GMP certification (WHO-GMP, cGMP), ISO certifications, and, ideally, registration with regulatory authorities like the FDA or EMA to ensure compliance with international quality standards.

3. Is there a significant difference between suppliers based on geographic location?
Yes. Chinese and Indian suppliers often offer cost advantages but must demonstrate compliance with international standards. European and North American suppliers typically have higher regulatory rigor, which can impact their sourcing suitability for certain markets.

4. How is the supply of sulfacetamide sodium expected to evolve in the near future?
The market is expected to see increased diversification, with new entrants from Southeast Asia and Africa, driven by rising demand and the need for more resilient supply chains. Technological advances will also improve sustainability and cost-effectiveness.

5. What are the primary criteria for selecting a sulfacetamide sodium supplier?
Regulatory compliance, quality assurance, manufacturing capacity, supply reliability, pricing competitiveness, and geopolitical stability are key considerations.

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Citations

1. Jiangsu Sinomed Pharmaceutical Co., Ltd. Company website.
2. Zhejiang Hisoar Pharmaceutical Co., Ltd. Company profile.
3. Vinayak Organics. Official site.
4. HanseChem. Product offerings.
5. Thermo Fisher Scientific. API services.
6. Zhejiang Medicine Co., Ltd. Corporate information.
7. Biocon Limited. Contract manufacturing details.