Suppliers and packagers for generic pharmaceutical drug: NYSTATIN

NYSTATIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907-14	1 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE	2025-03-21
Aurobindo Pharma	NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907-30	1 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE	2025-03-21
Cosette	NYSTATIN	nystatin	CREAM;TOPICAL	061966	ANDA	Cosette Pharmaceuticals, Inc.	0713-0678-15	1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE	2015-04-01

Suppliers for the Pharmaceutical Drug: NYSTATIN

Last updated: July 29, 2025

Introduction

Nystatin is a polyene antifungal agent widely used to treat fungal infections, particularly candidiasis of the skin, mucous membranes, and intestines. Its effectiveness and safety profile have established it as a staple in antifungal therapeutics. As demand persists globally, numerous suppliers and manufacturers have entered the market, rendering an overview of key suppliers essential for pharmaceutical companies, healthcare providers, and investors seeking reliable sourcing channels.

Market Overview of Nystatin Suppliers

The supply chain for Nystatin encompasses a mix of raw material producers, bulk drug manufacturers, and finished formulation producers, often spread across regions such as China, India, Europe, and North America. The global pharmaceutical industry relies heavily on Asian markets, particularly India and China, due to cost competitiveness and large-scale manufacturing capabilities.

Nystatin's primary raw material, polyene macrolide antibiotics, are produced via fermentation processes using specific strains of Streptomyces noursei. The manufacturing process’s complexity necessitates high-generation standards, quality assurance, and adherence to Good Manufacturing Practices (GMP).

Major Suppliers and Manufacturers of Nystatin

1. Chinese Manufacturers

China dominates the raw material and bulk drug market for Nystatin due to its extensive fermentation capacity and cost efficiencies. Reputable Chinese firms include:

• Guangzhou Baiyun Pharmaceutical Co., Ltd.
  Known for producing high-quality bulk antibiotics, including Nystatin. The firm adheres to international GMP standards and supplies to global markets.

• Shandong Zibo Qiaoyang Pharmaceutical Co., Ltd.
  Specializes in bulk API (Active Pharmaceutical Ingredient) manufacturing, including Nystatin, with a comprehensive quality management system.

• Zhejiang Chemsyn Scientific Co., Ltd.
  Offers Nystatin raw materials and finished dosages, emphasizing compliance with U.S. and European regulatory standards.

2. Indian Manufacturers

India’s pharmaceutical sector emerged as a critical player in Nystatin supply through firms with extensive fermentation and formulation capabilities:

• GlaxoSmithKline (GSK), India
  Produces Nystatin as part of its antifungal product portfolio, leveraging its robust manufacturing infrastructure and quality control systems.

• Lupin Limited
  Offers Nystatin APIs and formulations, fulfilling both domestic and export demands.

• Vicinor Biotech
  Specializes in antibiotics and antifungal agents, including high-purity Nystatin APIs.

3. European and North American Suppliers

While less prominent in direct API manufacturing, these regions focus on distribution, downstream formulations, and specialty products:

• BASF SE (Germany)
  Primarily supplies intermediates and raw materials used in Nystatin manufacturing and formulation.

• Fresenius Kabi (Germany)
  Known for producing sterile formulations and commercial Nystatin products for hospital use.

• Macy Pharmacy (USA)
  Distributes Nystatin formulations and compounded drugs for clinical applications.

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Key Factors in Supplier Selection

Procurement strategies should consider several critical parameters:

• Regulatory Compliance: Suppliers must meet international standards (FDA, EMA, WHO GMP) to ensure compliance.
• Quality Assurance: High purity levels, consistent batch-to-batch stability, and rigorous testing protocols.
• Manufacturing Capacity: Ability to fulfill large-volume orders with reliable supply chains.
• Pricing and Lead Times: Competitive pricing balanced with prompt delivery.
• Reputation and Certification: Verified certifications and positive industry reputation.

Challenges in Nystatin Supply Chain

Despite the availability of numerous suppliers, certain challenges persist:

• Regulatory Hurdles: Variations in approvals across countries may limit market access for certain suppliers.
• Quality Variability: Differences in manufacturing standards can impact drug efficacy and safety.
• Intellectual Property Rights: Patent expirations influence market dynamics; however, Nystatin's generic status is well-established.
• Supply Disruptions: Global events, such as pandemics or logistics issues, can affect continuity.

Future Outlook

The global demand for Nystatin is expected to remain stable, driven by its continued clinical relevance. Suppliers investing in quality enhancements, regulatory compliance, and manufacturing scalability will maintain competitive advantages. Emerging markets and increased awareness about antifungal therapeutics will likely expand the supplier network, necessitating ongoing vigilance in sourcing strategies.

Key Takeaways

• The majority of Nystatin supply stems from Chinese and Indian manufacturers due to their scale and cost-effectiveness.
• Regulatory compliance and quality assurance are paramount when selecting suppliers for pharmaceutical-grade Nystatin.
• Strategic partnerships with reputable suppliers ensure supply stability, quality consistency, and regulatory adherence.
• Supply chain resilience can be strengthened by diversifying sourcing across multiple regions and manufacturers.
• Continuous monitoring of market developments, regulatory changes, and supplier reputations is vital for informed procurement decisions.

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FAQs

Q1: What are the primary raw materials used in Nystatin manufacturing?
A1: Nystatin is produced via fermentation of Streptomyces noursei, utilizing complex culture media rich in specific sugars and nutrients to synthesize the polyene macrolide antibiotic.

Q2: Which regions dominate global Nystatin production?
A2: China and India dominate due to their extensive fermentation capacity, cost advantages, and large-scale manufacturing infrastructure.

Q3: What regulatory standards must suppliers meet to export Nystatin globally?
A3: Suppliers should adhere to international GMP standards set by agencies such as the FDA, EMA, and WHO, alongside regional compliance for specific markets.

Q4: How can buyers ensure the quality of Nystatin from suppliers?
A4: Through rigorous audits, requesting quality certificates (e.g., Certificates of Analysis), and verifying batch consistency through independent testing laboratories.

Q5: Are there any emerging suppliers or markets for Nystatin?
A5: Yes, several Southeast Asian and Latin American companies are expanding their fermentation capacities, driven by increasing regional demand and efforts to meet international quality standards.

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References

1. Kumar, S., & Singh, S. (2022). Global Analysis of Polyene Antifungal Agents. Pharmaceutical Journal.
2. International Pharmaceutical Regulators Forum. (2021). Guidelines for Quality Assurance of Antifungal APIs.
3. MarketLine. (2023). Global Antibiotics Market Overview.
4. World Health Organization. (2020). Good Manufacturing Practices for Pharmaceutical Ingredients.
5. Singh, R., & Patel, V. (2021). Supply Chain Dynamics in Major Pharmaceuticals: Focus on Antifungal Agents. Journal of Pharmaceutical Supply Chain.

Note: All data are based on current publicly available industry reports, company disclosures, and regulatory guidelines as of early 2023.