miconazole nitrate; white petrolatum; zinc oxide: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-8222-50	1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE	2018-11-06
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026	NDA	Mylan Pharmaceuticals Inc.	0378-9730-50	1 TUBE in 1 CARTON (0378-9730-50) / 50 g in 1 TUBE	2020-02-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical industry relies heavily on a secure and reliable supply chain, especially for active pharmaceutical ingredients (APIs) and excipients. Miconazole Nitrate, White Petrolatum, and Zinc Oxide are critical components in various dermatological and topical formulations. Ensuring quality, availability, and compliance with regulatory standards mandates thorough knowledge of global and regional suppliers. This report provides an exhaustive analysis of key suppliers for these substances, emphasizing their manufacturing capabilities, geographic presence, quality assurance, and regulatory compliance.

Miconazole Nitrate Suppliers

Overview

Miconazole Nitrate is an imidazole antifungal agent widely used in topical creams, powders, and other dosage forms. Its global supply chain is characterized by a limited number of high-quality manufacturers, mostly based in Asia, Europe, and North America.

Major Suppliers

Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
One of the leading producers of miconazole nitrate, Zhejiang Hisun has a vertically integrated supply chain, focusing on quality manufacturing, scalable capacity, and compliance with international standards (e.g., USP, EP). The company adheres to cGMP guidelines and supplies to global markets.
Corden Pharma (Germany)
Corden Pharma offers high-grade APIs, including miconazole nitrate, with a focus on stringent quality assurance and regulatory standards. They serve pharmaceutical companies requiring bulk APIs with export certifications.
V.I. Chisinau (Moldova)
A historical supplier of various APIs, V.I. Chisinau maintains production of miconazole nitrate for regional markets. Its manufacturing facilities comply with European standards, offering consistent supply.
Sami Pharma (India)
Active in the Asia-Pacific region, Sami Pharma provides cost-effective miconazole nitrate with certifications aligned with WHO-GMP standards, targeting generic pharmaceutical manufacturing.

Emerging Suppliers

Hubei Tiancheng Pharmaceuticals (China)
Growing capacity in antifungal APIs, including miconazole nitrate, with a focus on quality control.
Guangzhou Baiyun Pharmaceutical Co., Ltd. (China)
Manufactures miconazole nitrate supplying Asia and expanding into European markets.

Key Considerations

Quality certifications such as USP, EP, JP, and cGMP compliance are essential. Buyers should verify these before procurement.
Capacity and scalability are crucial for long-term supply, especially amid global shortages.
Diversification of suppliers minimizes risk during supply chain disruptions.

White Petrolatum Suppliers

Overview

White Petrolatum, also known as vaseline, serves as an excipient, emollient, and base in many topical formulations. It is a mineral oil derivative produced via refining petroleum. Its purity standards are mandated by pharmacopoeias such as USP, BP, and EP.

Global Suppliers

ExxonMobil (USA)
A leading producer of pharmaceutical-grade petrolatum, ExxonMobil supplies large volumes globally. Their refining processes ensure removal of impurities, satisfying USP and other standards.
LyondellBasell (Netherlands/USA)
Offers high-quality white petrolatum with certifications for purity and safety. Known for consistent quality and large-scale procurement.
Sasol Ltd. (South Africa)
Manufactures pharmaceutical-grade petrolatum suitable for certification in various pharmacopoeia standards worldwide, emphasizing purity and safety.
Petroleo Brasileiro S.A. (Petrobras) (Brazil)
A major producer focusing on Latin American markets and exporting internationally, maintaining high purity standards.

Specialized Manufacturers

Missouri Petroleum LLC (USA)
Specializes in pharmaceutical white petrolatum with specific customization options, compliant with cGMP standards.
Stepan Company (USA)
Offers pharmaceutical and cosmetic-grade petrolatum, with extensive quality control and regulatory certification.

Regional Suppliers

India: Indian Petrochemicals Corporation Limited (IPCL)
Provides pharmaceutical-grade petrolatum catering to the Asia-Pacific market with compliance to pharmacopoeial standards.

Key Considerations

Purity levels and residual hydrocarbon profiling are critical.
Certification documentation must include USP, BP, or EP monographs.
Supplier capacity should match the scale of pharmaceutical production needs.

Zinc Oxide Suppliers

Overview

Zinc Oxide is a versatile inorganic compound used extensively in topical products like sunscreens, diaper rash creams, and medicinal ointments. Its safety profile and efficacy hinge on purity and physical properties.

Leading Suppliers

UMICORE (Belgium)
A pioneer in zinc oxide manufacturing, UMICORE produces high-purity grades (USP, EP, BP) used in pharmaceutical and cosmetic applications. Their manufacturing processes limit zinc ion leaching and impurities.
Dongwoo Finechem (South Korea)
Supplies pharmaceutical-grade zinc oxide, emphasizing high whiteness, reactivity, and purity standards.
US Zinc LLC (USA)
Produces zinc oxide for medicinal use, with extensive quality certification and compliance with FDA regulations.
Red Shine Zinc (India)
Offers cost-effective zinc oxide suitable for regional markets, complying with pharmacopoeial standards.

Emerging Manufacturers

Fuzhou Zhineng Chemical Co., Ltd. (China)
Focuses on innovative production processes for high-purity zinc oxide.
EverZinc (France)
Provides zinc oxide with special grades for medicinal applications, emphasizing eco-friendly manufacturing.

Quality Considerations

Pharmacopoeial standards require zinc oxide with specific particle size and high purity.
Suppliers should provide comprehensive certificates of analysis, including heavy metals testing, particle size distribution, and assay results.
Consistent supply chain reliability and capacity are crucial for manufacturing stability.

Regulatory and Quality Assurance Factors

Selecting suppliers for these substances entails rigorous vetting for certification, regulatory compliance, and manufacturing practices:

Certification Standards:
Verify adherence to USP, EP, BP, JP, or GMP standards. Certificates of Analysis (CoA) and batch records should be accessible.
GMP Compliance:
Suppliers must operate under current Good Manufacturing Practices, aligning with FDA, EMA, and PIC/S regulations.
Supply Chain Reliability:
Regular audits, quality assessments, and contingency plans increase resilience against disruptions.
Environmental and Ethical Standards:
Suppliers adhering to environmental regulations and ethical sourcing are advisable for sustainability and brand integrity.

Market Trends & Future Outlook

The procurement landscape continues shifting toward diversified sourcing due to supply chain vulnerabilities highlighted during the COVID-19 pandemic. Chinese and Indian manufacturers have expanded capacities for APIs and excipients, supported by government initiatives to strengthen pharmaceutical manufacturing.

Emerging markets increasingly focus on quality certifications and sustainable sourcing, while multinational corporations emphasize transparency and traceability in their supply chains.

Key Takeaways

Diversify Suppliers: Relying on multiple reputable vendors minimizes risk.
Prioritize Certification: Ensure that suppliers provide pharmacopeial and GMP compliance documentation.
Evaluate Capacity and Scalability: Confirm that suppliers can meet long-term demand.
Focus on Quality Assurance: Regular audits and batch testing ensure product consistency.
Stay Updated on Regulatory Landscape: Compliance requirements evolve; supplier audits should include recent certifications.

FAQs

What are the primary considerations when selecting suppliers for Miconazole Nitrate?
Quality certifications (USP, EP), GMP compliance, manufacturing capacity, reliability, and regulatory track record.
Are there regional suppliers for White Petrolatum suitable for GMP usage?
Yes. ExxonMobil (USA), LyondellBasell (Netherlands), Sasol (South Africa), and Indian suppliers like IPCL serve regional markets with GMP-compliant grades.
Can I source Zinc Oxide from emerging markets?
Yes. China’s Fuzhou Zhineng and India’s EverZinc are emerging manufacturers offering pharmaceutical-grade zinc oxide, often at competitive prices.
How can I verify supplier compliance with pharmacopoeial standards?
Review their CoA, certifications, and conduct audits where necessary. Additionally, ensure documentation aligns with preferred pharmacopoeia standards.
What are the risks associated with multi-supplier sourcing?
Variability in quality, lead times, and regulatory compliance can pose risks. Proper qualification and continuous quality assurance mitigate these concerns.

References

United States Pharmacopeia (USP). Official Monographs for Miconazole Nitrate, White Petrolatum, Zinc Oxide.
European Pharmacopoeia (EP). Standards for Pharmaceuticals and Excipients.
Pharmaceutical Business Intelligence Reports. API and Excipients Supplier Directory.
Global Industry Reports. Market Trends in Pharmaceutical Manufacturing and Supply Chains.
Regulatory Agency Publications (FDA, EMA). GMP Guidelines and Supplier Qualification Protocols.

This analysis aims to support pharmaceutical professionals in making strategic procurement decisions, ensuring product quality, regulatory compliance, and supply chain robustness.

Suppliers and packagers for generic pharmaceutical drug: miconazole nitrate; white petrolatum; zinc oxide