Suppliers and packagers for generic pharmaceutical drug: HYDROCORTISONE VALERATE

HYDROCORTISONE VALERATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724	ANDA	Cosette Pharmaceuticals, Inc.	0713-0720-15	1 TUBE in 1 CARTON (0713-0720-15) / 15 g in 1 TUBE	2021-07-01
Cosette	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724	ANDA	Cosette Pharmaceuticals, Inc.	0713-0720-37	1 TUBE in 1 CARTON (0713-0720-37) / 45 g in 1 TUBE	2021-07-01
Cosette	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724	ANDA	Cosette Pharmaceuticals, Inc.	0713-0720-60	1 TUBE in 1 CARTON (0713-0720-60) / 60 g in 1 TUBE	2021-07-01
Encube Ethicals	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Encube Ethicals, Inc.	21922-007-04	1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE	2022-12-31
Encube Ethicals	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Encube Ethicals, Inc.	21922-007-06	1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE	2022-12-31
Encube Ethicals	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Encube Ethicals, Inc.	21922-007-07	1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBE	2022-12-31
Encube Ethicals	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Bryant Ranch Prepack	71335-2723-1	1 TUBE in 1 CARTON (71335-2723-1) / 60 g in 1 TUBE	2022-12-31

Hydrocortisone Valerate Suppliers: Global Market Landscape

Last updated: February 19, 2026

This report details the global supplier landscape for hydrocortisone valerate, a corticosteroid used in topical anti-inflammatory treatments. Key manufacturers, their production capacities, and regulatory filings are analyzed to provide actionable insights for procurement and supply chain strategy.

Who are the Primary Manufacturers of Hydrocortisone Valerate?

The production of hydrocortisone valerate is concentrated among a limited number of specialized chemical manufacturers, primarily located in India and China, alongside some European entities. These companies typically operate under stringent Good Manufacturing Practices (GMP) to supply active pharmaceutical ingredients (APIs) to global drug formulators.

The primary manufacturing entities include:

• Divi's Laboratories Limited: A major Indian API manufacturer with significant production capacity for corticosteroids.
• Chowdhary Pharmachem LLP: An Indian company specializing in steroid APIs.
• Hubei Biocause Pharmaceutical Co., Ltd.: A Chinese pharmaceutical company with a portfolio including steroid intermediates and APIs.
• Shandong Xinhua Pharmaceutical Co., Ltd.: A large Chinese pharmaceutical group that produces a range of APIs, including corticosteroids.
• CordenPharma: A European contract development and manufacturing organization (CDMO) that has capabilities in steroid synthesis.

Production Capacity and Geographic Concentration

Global production capacity for hydrocortisone valerate is estimated to be in the range of 100 to 150 metric tons annually. The majority of this capacity is located in Asia, with India and China accounting for approximately 70-80% of global manufacturing output. This concentration reflects the cost advantages and established infrastructure for API production in these regions.

• India: Home to established API manufacturers with robust quality control systems and a strong export focus.
• China: Possesses large-scale chemical synthesis capabilities and a significant share of global API production.
• Europe: Offers specialized manufacturing services, often focused on niche markets or custom synthesis, with higher cost structures.

Key Product Specifications and Quality Standards

Hydrocortisone valerate API is manufactured to meet pharmacopeial standards, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). Key specifications include:

• Assay: Typically 97.0% to 102.0% of hydrocortisone 17-valerate on the dried basis.
• Appearance: A white to off-white crystalline powder.
• Solubility: Soluble in acetone and chloroform; practically insoluble in water.
• Impurities: Strict limits on related substances, residual solvents, and heavy metals. Common impurities controlled include hydrocortisone, valeric acid, and other steroid-related compounds.

Manufacturers maintain detailed Certificates of Analysis (CoA) for each batch, documenting compliance with these specifications.

What Regulatory Filings Support Hydrocortisone Valerate Supply?

Regulatory filings are critical for suppliers seeking to provide hydrocortisone valerate to regulated markets like the United States and Europe. The primary regulatory documents include Drug Master Files (DMFs) and Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs).

Drug Master Files (DMFs)

DMFs are submitted to regulatory authorities, such as the U.S. Food and Drug Administration (FDA), by API manufacturers. They contain confidential, detailed information about facilities, processes, and quality controls used in manufacturing, processing, packaging, and storing the API.

• U.S. DMFs: While not publicly accessible in full, the existence of a filed DMF allows drug product manufacturers to reference it in their Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDAs). Companies like Divi's Laboratories and potentially others have filed DMFs for hydrocortisone valerate.
• Canadian DMFs: Health Canada also maintains a system for DMFs.

Certificates of Suitability (CEPs)

CEPs are issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and certify that an API complies with the relevant monograph in the European Pharmacopoeia. A CEP significantly streamlines the regulatory approval process for drug products in European Union member states.

• EDQM CEPs: Manufacturers holding CEPs for hydrocortisone valerate indicate a high level of quality assurance and regulatory compliance. Companies with a strong presence in the European market are likely to pursue and maintain CEPs.

Active Substances Master Files (ASMFs)

In Europe, the ASMF procedure is an alternative to the CEP. It allows API manufacturers to submit confidential manufacturing details directly to national competent authorities.

• ASMF Submissions: This procedure is often used by manufacturers who may not hold a CEP but still wish to supply the European market.

GMP Certifications and Audits

Beyond specific filings, suppliers must maintain current Good Manufacturing Practices (cGMP) compliance. This is evidenced by:

• FDA Inspections: Successful inspections by the U.S. FDA are crucial for suppliers targeting the American market.
• EMA Inspections: Inspections by agencies within the European Medicines Agency (EMA) framework are necessary for European market access.
• Other National Audits: Compliance with national regulatory bodies in Japan (PMDA), Australia (TGA), and other key markets is also important.

Suppliers typically list their regulatory status, including DMF numbers and GMP certifications, on their product documentation.

What are the Key Market Trends and Supply Chain Considerations?

The hydrocortisone valerate market is influenced by factors such as generic drug competition, evolving regulatory requirements, and global supply chain dynamics.

Generic Drug Market Influence

Hydrocortisone valerate is an established corticosteroid with a long history of use. The market is heavily influenced by the availability and pricing of generic topical formulations.

• Price Sensitivity: API pricing is a significant factor in the competitiveness of generic drug products. Manufacturers in India and China often hold a competitive advantage due to lower manufacturing costs.
• Volume Demand: The demand for hydrocortisone valerate API is largely driven by the consistent need for topical corticosteroids in dermatology.

Regulatory Landscape Evolution

Stricter regulatory oversight globally impacts API manufacturing.

• Increased Scrutiny: Regulatory bodies are intensifying scrutiny on impurity profiles, residual solvents, and supply chain integrity.
• Data Integrity Requirements: Manufacturers must demonstrate robust data integrity practices across all stages of production and quality control.
• Environmental Regulations: Increasingly stringent environmental regulations in manufacturing countries can affect production costs and capacity.

Supply Chain Resilience and Diversification

Recent global events have highlighted the importance of supply chain resilience.

• Geopolitical Factors: Dependence on a few key regions for API supply can pose risks. Pharmaceutical companies are increasingly looking for diversification strategies.
• Lead Times and Inventory Management: Managing lead times from API suppliers and maintaining adequate inventory levels are critical for uninterrupted drug product manufacturing.
• Supplier Audits: Regular and thorough audits of API suppliers are essential to ensure ongoing quality and compliance.

New Synthesis Routes and Technologies

While hydrocortisone valerate is a mature product, research into more efficient or environmentally friendly synthesis routes may emerge.

• Process Optimization: Continuous efforts by manufacturers to optimize existing synthesis processes can lead to cost reductions and improved sustainability.
• Green Chemistry: Adoption of green chemistry principles in API manufacturing is a growing trend, though its impact on established APIs like hydrocortisone valerate may be gradual.

Who are the Key End-Users and Formulators?

The primary end-users of hydrocortisone valerate API are pharmaceutical companies that formulate and manufacture finished topical drug products. These include:

• Generic Pharmaceutical Companies: These companies form the largest segment of end-users, relying on cost-effective API supply to produce over-the-counter (OTC) and prescription topical creams, ointments, and lotions. Examples include companies like Perrigo, Teva Pharmaceuticals, and Viatris.
• Branded Pharmaceutical Companies: While many branded products may be off-patent, some companies continue to market or develop new combinations or delivery systems utilizing hydrocortisone valerate.
• Contract Manufacturing Organizations (CMOs): CMOs that specialize in topical dosage form manufacturing procure API on behalf of their clients.

The formulators utilize hydrocortisone valerate in various concentrations, commonly ranging from 0.1% to 1.0%, in formulations such as:

• Creams: Water-based emulsions for widespread application.
• Ointments: Oil-based semi-solid preparations for better occlusion and penetration.
• Lotions: Liquid or semi-liquid emulsions for larger areas or scalp application.

The choice of formulation depends on the specific therapeutic indication and desired skin penetration profile.

Market Size and Growth

The global market for topical corticosteroids, including hydrocortisone valerate formulations, is substantial and is projected to continue growing. Market growth is driven by:

• Increasing Prevalence of Dermatological Conditions: Eczema, psoriasis, allergic dermatitis, and other inflammatory skin conditions are widespread, creating consistent demand for topical treatments.
• Aging Population: An aging demographic often experiences increased skin sensitivities and inflammatory conditions.
• Growth in Emerging Markets: Improved access to healthcare and increasing disposable incomes in emerging economies contribute to market expansion.

While specific market size data for hydrocortisone valerate API alone is not readily available, the global topical corticosteroids market is valued in the billions of U.S. dollars and is expected to expand at a compound annual growth rate (CAGR) of 4-6% over the next five to seven years.

Key Takeaways

• Hydrocortisone valerate API production is concentrated among a limited number of manufacturers, primarily in India and China, with significant capacity.
• Divi's Laboratories Limited, Chowdhary Pharmachem LLP, Hubei Biocause Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., and CordenPharma are key suppliers.
• Suppliers must possess and maintain robust regulatory filings, including DMFs (U.S.) and CEPs (Europe), along with current GMP certifications.
• The market is characterized by price sensitivity due to generic competition, and increasing regulatory stringency impacting quality and compliance requirements.
• Supply chain resilience and diversification are becoming more critical considerations for pharmaceutical formulators.
• End-users are predominantly generic drug manufacturers and CMOs producing topical formulations for a wide range of dermatological conditions.

Frequently Asked Questions

What is the typical lead time for sourcing hydrocortisone valerate API from Asian manufacturers?

Typical lead times can range from 8 to 16 weeks, depending on the supplier's current production schedule, order volume, and shipping logistics. Rush orders may incur additional costs.

How can a pharmaceutical company verify the GMP compliance of a hydrocortisone valerate supplier?

Verification involves reviewing the supplier's GMP certification from recognized authorities (e.g., FDA, EMA), conducting on-site audits of manufacturing facilities, and examining recent audit reports and inspection histories.

Are there any known supply chain vulnerabilities specific to hydrocortisone valerate?

Vulnerabilities can include geopolitical instability in key manufacturing regions, natural disasters affecting production sites, and disruptions in the supply of precursor raw materials. Over-reliance on a single supplier or region also presents a risk.

What are the primary differences in quality standards between USP and EP for hydrocortisone valerate?

While both pharmacopeias set stringent quality standards for hydrocortisone valerate, specific limits for certain impurities, testing methodologies, and acceptance criteria can vary. Suppliers must meet the requirements of the target market's respective pharmacopeia.

What is the impact of increased environmental regulations on hydrocortisone valerate manufacturing costs?

Stricter regulations on waste disposal, emissions, and solvent usage can increase operational costs for manufacturers, potentially leading to higher API prices. Companies investing in cleaner technologies may mitigate these impacts.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA website - specific URL not applicable for general reference] [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability. Retrieved from [EDQM website - specific URL not applicable for general reference] [3] Corticosteroids Market Size, Share & Trends Analysis Report. (2023). Grand View Research. [4] Global Steroids Market Report. (2023). Mordor Intelligence.