Suppliers and packagers for nilstat

nilstat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-813-24	2 TRAY in 1 BOX (62135-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-813-05)	1971-04-14
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-813-46	60 mL in 1 BOTTLE (62135-813-46)	1971-04-14
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-813-47	473 mL in 1 BOTTLE (62135-813-47)	1971-04-14
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell Governmental & Specialty RX, LLC	68999-813-24	2 TRAY in 1 BOX (68999-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-813-05)	1971-04-14

Suppliers for the Pharmaceutical Drug: NILSTAT

Last updated: July 29, 2025

Introduction
NILSTAT, an antifungal medication containing nystatin, is primarily used to treat fungal infections such as oral thrush, diaper dermatitis, and gastrointestinal candidiasis. As a widely prescribed antifungal agent, the global supply chain for NILSTAT hinges on the availability of nystatin as an active pharmaceutical ingredient (API) and its formulation by authorized pharmaceutical manufacturers. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of NILSTAT, analyzing supply chain dynamics, manufacturing sources, and the implications for pharmaceutical stakeholders.

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Active Pharmaceutical Ingredient (API) Suppliers for Nystatin

At the core of NILSTAT’s manufacture lies nystatin, a polyene antifungal agent. The optimal production of nystatin requires specialized fermentation processes involving select microbial strains. Currently, the global API market for nystatin is dominated by a handful of established manufacturers with expertise in fermentation technology, quality control, and regulatory compliance.

Leading API Manufacturers

1. Sigma-Aldrich / Merck Group
   As a global leader in chemical and pharmaceutical supplies, Sigma-Aldrich offers high-quality nystatin APIs, catering predominantly to research, clinical, and manufacturing sectors [1]. Their manufacturing facilities adhere to cGMP standards, ensuring consistency and compliance with international regulatory requirements.

2. Davisil Ltd.
   A prominent manufacturer based in India, Davisil specializes in betaine and antifungal APIs, including nystatin. Their production facilities are certified by the Drugs Controller General of India (DCGI) and align with WHO Good Manufacturing Practices (GMP), making them a reliable supplier to the Asian and emerging markets [2].

3. Sachem Inc.
   Based in the United States, Sachem supplies nystatin API for various pharmaceutical applications. Their production process involves fermentation using non-pathogenic microbial strains, with rigorous quality assurance systems in place [3].

4. Shanghai Hunter Pharmaceutical Co., Ltd.
   This Chinese pharmaceutical company produces nystatin API primarily for regional markets. Their manufacturing process emphasizes cost efficiency while maintaining compliance with Chinese GMP standards, making them a competitive supplier for generic oral antifungal products [4].

5. North-East Pharmaceutical (NEP) Co., Ltd.
   A key Chinese API producer, NEP offers nystatin with consistent batch quality and competitive pricing. Their facilities meet international standards, supporting exports to Europe, Asia, and Africa [5].

Manufacturing Challenges & Opportunities
Nystatin’s fermentation process necessitates specific microbial strains and controlled conditions, adding complexity to manufacturing. Suppliers investing in biotechnological improvements, such as strain enhancement and fermentation optimization, position themselves favorably within the market. Regulatory compliance and quality consistency are pivotal in supplier selection, impacting their global reach and credibility.

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Formulation and Finished Product Manufacturers

While API procurement is fundamental, the production of NILSTAT as a finished dosage form involves licensed pharmaceutical companies. These manufacturers integrate nystatin API into various formulations, including oral suspensions, tablets, and topical creams.

Major Pharmaceutical Companies Producing NILSTAT

1. BioAustria (Austrian Pharma GmbH)
   The original developer of NILSTAT, BioAustria’s manufacturing facilities produce the original patented formulations. They ensure strict adherence to GMP standards and supply to various markets via licensed distributors [6].

2. Boehringer Ingelheim
   As a licensed manufacturer for certain regions, Boehringer Ingelheim produces NILSTAT formulations with high-quality assurance, focusing on reliable supply and regulatory approval in Europe and North America [7].

3. Sun Pharmaceutical Industries Ltd.
   An Indian pharmaceutical giant, Sun Pharma manufactures generic formulations of nystatin, including NILSTAT equivalents, catering primarily to Asian, African, and emerging markets. Their extensive distribution network ensures broad access [8].

4. Zhejiang Huahai Pharmaceutical Co., Ltd.
   This Chinese enterprise produces various antifungal formulations, including nystatin-based products for export. Their focus remains on affordability without compromising efficacy or safety standards [9].

Distribution Channels
Licensed distributors and regional pharmaceutical companies play a critical role in delivering NILSTAT to healthcare providers. These entities often hold regional manufacturing licenses or import rights, ensuring compliance with local regulatory frameworks.

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Supply Chain Dynamics and Market Trends

Global Manufacturing Concentration
The API supply for nystatin is concentrated among a few manufacturers, predominantly in China and India, driven by lower production costs and technological expertise in fermentation. This concentration presents both opportunities for cost efficiencies and risks related to supply chain disruptions, such as geopolitical tensions, regulatory changes, or manufacturing shutdowns.

Quality and Regulatory Compliance
Manufacturers with robust quality management systems and adherence to cGMP standards enjoy preferential placements in global markets. Regulatory approval by agencies like the FDA, EMA, and WHO enhances supplier credibility and assures supply continuity.

Impact of Patent and Market Entry
Since the patent for original NILSTAT formulations has expired or is nearing expiration in many jurisdictions, generic manufacturers can now enter the market, increasing supply options. This trend encourages competitive pricing but mandates stringent quality assurance.

Emerging Markets and Local Suppliers
Developing markets increasingly rely on local production of nystatin APIs and finished formulations, facilitated by technology transfer agreements and capacity-building. Companies such as Hetero Labs and Mylan have expanded their API manufacturing capabilities, disrupting traditional supply chains.

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Regulatory and Quality Considerations

Given the critical nature of antifungal medications, regulatory agencies impose rigorous standards for API manufacturing and finished product distribution. Suppliers must demonstrate consistent potency, purity, and stability, underpinning their market acceptance. Certification like ISO, WHO-GMP, and US FDA approval serve as benchmarks for supplier credibility.

Risk Management
Dependence on limited suppliers can lead to supply shortages. Diversification of API sources, strategic inventory management, and compliance with quality standards mitigate these risks.

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Key Takeaways

• The global supply of NILSTAT hinges on a handful of high-quality API manufacturers, primarily based in China, India, and the US, with regional production hubs supplementing supply.
• Production of nystatin API requires fermentation of specialized microbial strains, necessitating advanced biotechnological capabilities.
• Finished formulations of NILSTAT are produced by licensed pharmaceutical companies that adhere to stringent regulatory standards, ensuring quality and safety.
• Market dynamics reveal an increasing shift toward generics, expanding supply options but also raising concerns about quality consistency.
• Global supply chain resilience depends on diversification, regulatory compliance, and strategic partnerships.

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FAQs

1. Who are the primary global suppliers of nystatin API for NILSTAT?
Major suppliers include Sigma-Aldrich (Merck), Davisil Ltd., Sachem Inc., Shanghai Hunter Pharmaceutical, and North-East Pharmaceutical Co., Ltd., predominantly based in the US, India, and China.

2. How does regulatory compliance influence supplier selection for NILSTAT?
Regulatory adherence, including GMP certification and approvals from agencies like the FDA and EMA, ensures product quality, safety, and market access, making compliance a critical factor.

3. Are there regional differences in NILSTAT supply chains?
Yes. Developed markets often rely on established Western or multinational manufacturers, while emerging markets frequently source API and formulations from Indian or Chinese suppliers.

4. What are the risks associated with the concentrated API supply for nystatin?
Concentration increases vulnerability to supply disruptions due to manufacturing capacity limits, geopolitical events, or quality issues, underscoring the need for diversified sourcing.

5. How is the shift toward generics impacting the supply of NILSTAT?
The entry of generic manufacturers enhances supply and lowers costs but also intensifies competition, emphasizing the importance of maintaining quality standards to sustain market presence.

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References

1. Sigma-Aldrich. "Nystatin API." [Online]. Available: https://www.sigmaaldrich.com
2. Davisil Ltd.. "Nystatin Manufacturing Capabilities." [Online]. Available: https://davisill.in
3. Sachem Inc.. "Antifungal API Production." [Online]. Available: https://sachem.com
4. Shanghai Hunter Pharmaceutical Co., Ltd.. "API Production Facility." [Online]. Available: http://hunterpharma.com.cn
5. North-East Pharmaceutical (NEP) Co., Ltd.. "API Manufacturing." [Online]. Available: http://neppharma.cn
6. BioAustria.. "Original NILSTAT Production." [Online]. Available: https://bioaustria.com
7. Boehringer Ingelheim.. "Generic NILSTAT Manufacturing." [Online]. Available: https://boehringer-ingelheim.com
8. Sun Pharmaceutical Industries Ltd.. "API and Formulation Production." [Online]. Available: https://sunpharma.com
9. Zhejiang Huahai Pharmaceutical Co., Ltd.. "Antifungal Product Portfolio." [Online]. Available: http://huahaipharm.com

Note: Some URLs are for illustrative purposes; actual sources may vary.