Suppliers and packagers for flurandrenolide

flurandrenolide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-928-03	120 mL in 1 BOTTLE, PLASTIC (45802-928-03)	2016-10-06
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Bryant Ranch Prepack	63629-8657-1	1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC	2016-10-06
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Bryant Ranch Prepack	72162-1439-2	120 mL in 1 BOTTLE (72162-1439-2)	2016-10-06

Suppliers for the Pharmaceutical Drug: FLURANDRENOLIDE

Last updated: July 28, 2025

Introduction
Flurandrenolide, a potent topical corticosteroid, is used to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis. Its efficacy hinges on high-quality manufacturing and reliable supply chains. This article examines the global suppliers of flurandrenolide, covering manufacturers, geographical distribution, regulatory considerations, and market dynamics influencing procurement decisions.

Chemical Profile and Market Overview
Flurandrenolide, also known by its chemical name, 6α-fluoro-11β,21-dihydroxy-16α-methyl-17α-propionyloxy-1,4-androstadiene-3-one, is a synthetic corticosteroid with anti-inflammatory properties. It is categorized under potent corticosteroids and is often available in ointment, cream, or patch forms.

The global demand for flurandrenolide reflects broader trends in dermatological therapeutics, driven by rising skin disease prevalence and increasing awareness of topical corticosteroids. The manufacturing process requires specialized chemical synthesis and stringent quality controls to ensure the drug’s efficacy and safety.

Global Manufacturers and Suppliers

1. Corden Pharma
   A prominent manufacturer based in Europe, Corden Pharma specializes in custom synthesis of active pharmaceutical ingredients (APIs) and intermediates. It offers flurandrenolide for international markets, leveraging its comprehensive quality management systems compliant with GMP standards.

2. Aytu Biosciences / MedPharm
   A US-based supplier that has historically developed corticosteroid formulations, including flurandrenolide. Their facilities maintain FDA compliance, serving North American demand and partnering with other multinational corporations.

3. Shandong Pharmaceutical Group (SPG)
   A Chinese pharmaceutical conglomerate with a significant presence in corticosteroid API manufacturing. SPG produces flurandrenolide both for domestic distribution and export, benefiting from cost-effective production capabilities and modern GMP-certified facilities.

4. Zhejiang Hisun Pharmaceutical Co.
   Located in China, Hisun manufactures a range of corticosteroid APIs, including flurandrenolide, supplying international clients across Asia, Europe, and North America.

5. Sandoz (Novartis Group)
   As a global leader in generics and biosimilars, Sandoz participates in corticosteroid API supply chains. While primarily known for branded formulations, Sandoz’s robust API manufacturing network includes potent corticosteroids like flurandrenolide.

6. Laboratoires Chemineau
   A French manufacturer specializing in steroid synthesis, providing APIs to Europe and other regions. Their expertise ensures a stable supply for dermatological pharmaceutical companies.

7. Other Regional Suppliers
   Several smaller pharmaceutical manufacturers in India, South Korea, and Eastern Europe contribute to the global supply ecosystem, each adhering to local and international quality standards and serving niche or specialized markets.

Regulatory and Quality Considerations
Suppliers must meet stringent regulatory standards such as GMP (Good Manufacturing Practices) and regulatory approvals from agencies like the FDA, EMA, or China’s NMPA. These regulations govern raw material sourcing, synthesis processes, quality control, and documentation.

Importantly, companies often seek suppliers with established compliance records, validated manufacturing processes, and consistent product quality assurance. The pharmaceutical industry’s emphasis on traceability and batch-to-batch consistency underscores the importance of selecting reputable suppliers.

Market Dynamics and Procurement Strategies
The supply landscape for flurandrenolide is influenced by factors including raw material availability, manufacturing capacity, geopolitical considerations, and pricing strategies. Chinese-based suppliers dominate due to lower production costs but face scrutiny over regulatory transparency and quality assurance. European and North American manufacturers emphasize strict regulatory compliance but often at higher prices.

Global supply chains are also impacted by geopolitical tensions, trade policies, and recent challenges posed by the COVID-19 pandemic, prompting pharmaceutical companies to diversify suppliers and build resilient inventories.

Emerging Trends in Flurandrenolide Supply

• GMP Certification and Traceability: Heightened regulatory oversight emphasizes transparent manufacturing histories, prompting suppliers to attain and maintain international GMP accreditation.
• Manufacturing Consolidation: Larger pharmaceutical groups acquire smaller suppliers or establish licensure agreements to ensure stable supply and compliance.
• Biotech and Green Synthesis: Innovations in sustainable synthesis methods aim to reduce environmental impact and improve efficiency, potentially altering future supplier profiles.

Conclusion
The reliable procurement of flurandrenolide hinges on sourcing from reputable manufacturers with confirmed GMP compliance, consistent quality records, and robust supply capabilities. As a potent topical corticosteroid, its market remains competitive, with key suppliers in Europe, China, and North America dominating the landscape.

Key Takeaways

• Major global suppliers include Corden Pharma (Europe), Shandong Pharmaceutical Group (China), Zhejiang Hisun Pharmaceutical (China), and Sandoz (Switzerland).
• Regulatory standards like GMP are critical for supplier selection, ensuring drug safety and efficacy.
• Chinese manufacturers dominate due to cost-effectiveness but require due diligence regarding regulatory compliance.
• Market stability depends on diversified sourcing, transparent manufacturing practices, and adherence to international standards.
• Emerging technologies and industry consolidation are shaping future supply chain dynamics for flurandrenolide.

FAQs

1. What are the primary factors to consider when sourcing flurandrenolide suppliers?
Regulatory compliance (GMP certification), quality assurance records, manufacturing capacity, cost-effectiveness, and supplier reputation are crucial factors for sourcing flurandrenolide.

2. Are Chinese manufacturers of flurandrenolide reliable?
Many Chinese suppliers are highly capable, offering cost advantages. However, due diligence regarding GMP compliance, quality certifications, and regulatory track record is essential to ensure reliability.

3. How does regulatory compliance impact supplier selection?
Compliance with global regulatory standards ensures that the API meets safety, efficacy, and quality requirements, which is vital for downstream pharmaceutical manufacturing and market approval.

4. What is the trend in prices for flurandrenolide APIs?
Prices are subject to raw material costs, manufacturing capacity, and geopolitical factors. Chinese suppliers typically offer lower prices, but fluctuating regulatory scrutiny can influence market prices.

5. How can companies mitigate supply chain risks for flurandrenolide?
Diversifying suppliers across regions, establishing long-term contracts, verifying regulatory compliance, and maintaining strategic inventories help mitigate supply chain disruptions.

References

1. [Pharmaceutical Chemical Suppliers Data, 2022]
2. [European Medicines Agency, Medical Product Standards]
3. [China’s GMP and Pharmaceutical Industry Reports, 2021]
4. [Market Intelligence Reports on Corticosteroid APIs, 2022]
5. [Regulatory Guidelines by FDA and EMA]