Suppliers and packagers for generic pharmaceutical drug: ACETIC ACID, GLACIAL; HYDROCORTISONE

ACETIC ACID, GLACIAL; HYDROCORTISONE

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 AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040609	ANDA	Cosette Pharmaceuticals, Inc.	0713-0849-09	1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE	2024-02-01
Taro	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	088759	ANDA	Sun Pharmaceutical Industries, Inc.	51672-3007-1	1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE	2005-04-28
Saptalis Pharms	VOSOL HC	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	012770	NDA AUTHORIZED GENERIC	Saptalis Pharmaceuticals, LLC	71656-064-10	1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER	2024-02-23

Pharmaceutical Suppliers for Acetic Acid, Glacial and Hydrocortisone

Last updated: February 19, 2026

This report analyzes key suppliers for two critical pharmaceutical raw materials: acetic acid, glacial and hydrocortisone. It identifies leading manufacturers, their production capacities, regulatory compliance, and recent market activities. The analysis focuses on suppliers with established track records and robust supply chains relevant for drug development and commercial manufacturing.

Who are the primary global suppliers of acetic acid, glacial for pharmaceutical use?

Major global manufacturers of acetic acid, glacial suitable for pharmaceutical applications include Celanese Corporation, Eastman Chemical Company, and LyondellBasell Industries N.V. These companies operate large-scale production facilities and adhere to stringent quality control measures to meet pharmaceutical industry standards.

Celanese Corporation

Celanese is a significant producer of acetic acid, with global manufacturing sites in the United States, Europe, and Asia. The company offers pharmaceutical-grade acetic acid, often branded under specific quality certifications. Its integrated production process allows for consistent supply.

• Production Capacity: Celanese operates multiple world-scale acetic acid production plants, contributing to a significant portion of global supply. Specific capacities are proprietary but are estimated to be in the millions of metric tons annually across its network.
• Regulatory Compliance: Celanese's pharmaceutical-grade products are manufactured in facilities adhering to Good Manufacturing Practices (GMP). The company provides documentation including Certificates of Analysis (CoA) and Material Safety Data Sheets (MSDS) for its pharmaceutical excipients.
• Market Presence: Celanese supplies to major pharmaceutical manufacturers worldwide, with established distribution channels.

Eastman Chemical Company

Eastman Chemical Company is another leading producer of acetic acid. Its product portfolio includes acetyls used in various industries, including pharmaceuticals. The company emphasizes product purity and reliability.

• Production Capacity: Eastman has substantial acetic acid production capabilities, with significant operations in the United States and the Netherlands.
• Regulatory Compliance: Eastman's pharmaceutical-grade acetic acid is produced under GMP conditions. The company supports customer regulatory filings by providing necessary documentation.
• Market Presence: Eastman serves a global customer base, including the pharmaceutical sector, through its extensive logistics network.

LyondellBasell Industries N.V.

LyondellBasell is a global chemical company that produces acetic acid as part of its acetyls product line. The company focuses on operational efficiency and supply chain security.

• Production Capacity: LyondellBasell operates large-scale acetic acid plants, primarily in North America and Europe.
• Regulatory Compliance: The company's production processes are designed to meet industry quality standards. Documentation for pharmaceutical use is available upon request.
• Market Presence: LyondellBasell supplies acetic acid to a broad range of industrial customers, including pharmaceutical intermediaries and active pharmaceutical ingredient (API) manufacturers.

What are the key characteristics and market dynamics for pharmaceutical-grade acetic acid, glacial?

Pharmaceutical-grade acetic acid, glacial (CAS No. 64-19-7) is a highly pure form of acetic acid, typically with a minimum purity of 99.5%. It is used as a solvent, pH adjuster, and intermediate in the synthesis of various pharmaceutical compounds.

• Purity Requirements: Pharmaceutical specifications (e.g., USP, EP, JP) mandate low levels of impurities, including heavy metals, aldehydes, and other organic compounds.
• Applications:
  • Synthesis of APIs, such as ibuprofen and paracetamol.
  • Use as an excipient in drug formulations, for example, in ophthalmic solutions to adjust pH.
  • Production of pharmaceutical intermediates.
• Market Drivers: Demand is driven by the growth of the global pharmaceutical market, increasing R&D in drug synthesis, and the use of acetic acid derivatives in novel therapeutics.
• Supply Chain Considerations: The stability of supply from large petrochemical producers is a key factor. Price fluctuations can be influenced by feedstock costs (methanol, carbon monoxide) and energy prices.

Who are the leading suppliers of hydrocortisone API for pharmaceutical applications?

The supply of hydrocortisone Active Pharmaceutical Ingredient (API) is more concentrated and subject to stricter regulatory oversight than commodity chemicals. Key global suppliers include:

• Millendo Therapeutics, Inc. (historically through acquisitions and partnerships)
• Amneal Pharmaceuticals LLC
• Teva Pharmaceutical Industries Ltd.
• Sanofi S.A. (historically through its specialty care divisions)
• Hospira, Inc. (now part of Pfizer)

These companies typically have specialized facilities for steroid synthesis and purification, complying with stringent cGMP regulations.

Amneal Pharmaceuticals LLC

Amneal is a significant player in the generic API market, including corticosteroids. The company focuses on developing and manufacturing complex APIs.

• Production Sites: Operates GMP-certified manufacturing facilities in the United States and India.
• Regulatory Compliance: Amneal's hydrocortisone API is manufactured in facilities inspected by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company files Drug Master Files (DMFs) for its APIs.
• Product Offerings: Provides hydrocortisone API for various dosage forms, including oral, topical, and injectable.

Teva Pharmaceutical Industries Ltd.

Teva, a global pharmaceutical giant, has a substantial API manufacturing division. It is a known supplier of various steroid APIs, including hydrocortisone.

• Production Sites: Teva has a global network of API manufacturing sites, with specialized capabilities for steroid synthesis.
• Regulatory Compliance: Adheres to strict cGMP standards across its manufacturing operations. Teva's DMFs are available for regulatory submissions by its pharmaceutical clients.
• Market Reach: Supplies hydrocortisone API to pharmaceutical companies worldwide for both generic and branded drug products.

Sanofi S.A.

While Sanofi's focus has shifted, its historical involvement and certain specialty divisions have been sources of hydrocortisone API. Acquisitions and divestitures can alter direct supply status.

• Production Capabilities: Sanofi has historically operated facilities with expertise in steroid chemistry and manufacturing.
• Regulatory Approvals: Products manufactured by Sanofi divisions have undergone rigorous regulatory review.

Pfizer Inc. (via Hospira acquisition)

Pfizer's acquisition of Hospira, a major sterile injectables manufacturer, includes capabilities for producing injectable APIs like hydrocortisone.

• Sterile Manufacturing: Expertise in aseptic processing and sterile API production is a key strength.
• Regulatory Standing: Facilities are subject to FDA and EMA inspections.

What are the market dynamics and regulatory considerations for hydrocortisone API?

Hydrocortisone is a glucocorticoid hormone used to treat a wide range of inflammatory and allergic conditions, adrenal insufficiency, and certain types of cancer.

• Manufacturing Complexity: The synthesis of hydrocortisone is a multi-step process involving complex organic chemistry and requires specialized equipment and expertise in steroid chemistry.
• Regulatory Scrutiny: As an API, hydrocortisone is subject to stringent quality and manufacturing standards, including cGMP. Suppliers must maintain up-to-date DMFs and undergo regular inspections.
• Market Segmentation: The hydrocortisone API market is segmented by therapeutic use (e.g., anti-inflammatory, hormone replacement) and by dosage form (e.g., oral tablets, topical creams, injectable solutions).
• Supply Chain Risks: The supply chain for hydrocortisone API can be susceptible to disruptions from raw material availability, manufacturing issues, or geopolitical factors affecting key production regions.
• Intellectual Property: While hydrocortisone itself is a well-established compound with expired patents, process patents related to its synthesis, purification, or specific polymorphic forms may exist and influence market competition.
• Pricing: API pricing is influenced by production costs, regulatory compliance expenses, market competition, and demand from generic and branded drug manufacturers.

How do regulatory requirements impact supplier selection for these materials?

Supplier selection for both acetic acid, glacial (pharmaceutical grade) and hydrocortisone API is heavily influenced by regulatory compliance.

• Acetic Acid, Glacial (Pharmaceutical Grade):

  • Certifications: Suppliers must demonstrate compliance with pharmacopoeial standards (USP, EP, JP).
  • GMP Manufacturing: Production facilities should operate under GMP conditions, though the stringency may vary depending on the direct use in the final dosage form (e.g., excipient vs. solvent in synthesis).
  • Documentation: Availability of CoAs, MSDS, and support for regulatory filings (e.g., information for inclusion in an API Master File or excipient file).
  • Auditability: The ability for pharmaceutical companies to audit supplier facilities is often a requirement.

• Hydrocortisone API:

  • cGMP Compliance: Absolute requirement for manufacturing facilities.
  • Drug Master Files (DMFs): Suppliers must maintain current and well-documented DMFs filed with regulatory authorities like the FDA. These filings provide confidential detailed information about facilities, processes, and controls used in manufacturing, processing, packaging, and storing the API.
  • Regulatory Inspections: Suppliers must have a history of successful inspections by major regulatory bodies (FDA, EMA, PMDA, etc.).
  • Quality Agreements: Pharmaceutical companies establish Quality Agreements with API suppliers to clearly define responsibilities regarding quality, regulatory compliance, change control, and handling of deviations.
  • Traceability: Robust systems for batch traceability from raw materials to the final API are essential.

What is the impact of global supply chain trends on these pharmaceutical raw materials?

Global supply chain trends have a significant impact on the availability, cost, and reliability of both acetic acid, glacial and hydrocortisone API.

• Geopolitical Factors: Trade disputes, political instability in manufacturing regions, and sanctions can disrupt supply chains.
• Logistics and Transportation: Increased shipping costs, port congestion, and availability of transport capacity can affect delivery times and final product cost.
• Raw Material Sourcing: The availability and pricing of upstream raw materials for both acetic acid (e.g., methanol, natural gas) and hydrocortisone (e.g., steroidal precursors, often derived from diosgenin or phytosterols) are critical. Sourcing these precursors can involve complex global networks.
• Reshoring and Nearshoring: Pharmaceutical companies are increasingly evaluating strategies to reduce reliance on single-source or geographically concentrated supply chains, leading to potential shifts in manufacturing locations.
• Sustainability and Environmental Regulations: Growing emphasis on sustainable manufacturing practices and stricter environmental regulations can influence production costs and require suppliers to invest in new technologies.
• Quality Control and Data Integrity: Heightened regulatory focus on data integrity in pharmaceutical manufacturing places pressure on suppliers to ensure robust quality management systems and transparent reporting.

Key Takeaways

• Acetic Acid, Glacial: Major global petrochemical companies like Celanese, Eastman Chemical, and LyondellBasell are primary suppliers. Pharmaceutical grade requires high purity (≥99.5%) and GMP manufacturing, with demand driven by API synthesis and excipient use. Supply is generally stable, influenced by feedstock and energy costs.
• Hydrocortisone API: Supply is more specialized and concentrated among companies such as Amneal Pharmaceuticals, Teva Pharmaceuticals, and entities within larger pharmaceutical conglomerates. Manufacturing involves complex steroid synthesis and requires strict adherence to cGMP.
• Regulatory Compliance is Paramount: For both materials, but especially for hydrocortisone API, regulatory approvals, cGMP manufacturing, and comprehensive documentation (e.g., DMFs) are critical selection criteria.
• Supply Chain Resilience: Pharmaceutical companies must consider geopolitical risks, logistics challenges, and raw material sourcing when evaluating suppliers for both acetic acid and hydrocortisone. Diversification of suppliers and geographical sourcing is a growing trend.

Frequently Asked Questions

1. What is the primary difference between industrial-grade and pharmaceutical-grade acetic acid, glacial? Pharmaceutical-grade acetic acid, glacial must meet stringent purity standards defined by pharmacopoeias (e.g., USP, EP, JP), ensuring minimal levels of specific impurities that could impact drug safety and efficacy. Industrial grades do not have these rigorous purity requirements.

2. How is the purity of hydrocortisone API typically verified by a pharmaceutical manufacturer? Purity is verified through a Certificate of Analysis (CoA) provided by the API supplier for each batch, detailing results of various tests (e.g., assay, related substances, residual solvents) against established specifications. Manufacturers also conduct their own incoming quality control testing and may perform audits of the supplier's manufacturing facility.

3. Are there any significant patent protections affecting the supply of generic hydrocortisone API? While the basic hydrocortisone molecule is off-patent, process patents related to novel synthesis routes, purification methods, specific polymorphic forms, or enantiomeric separation could exist. However, the primary supply of generic hydrocortisone API is generally not significantly constrained by active composition-of-matter patents.

4. What are the lead times typically associated with sourcing large quantities of hydrocortisone API from qualified suppliers? Lead times for hydrocortisone API can range from 3 to 9 months, depending on the supplier's production schedule, inventory levels, batch size, and the complexity of the manufacturing campaign. Establishing long-term supply agreements can help mitigate lead time variability.

5. How do price fluctuations in methanol and carbon monoxide impact the cost of acetic acid, glacial? Methanol and carbon monoxide are key feedstocks for the production of acetic acid via processes like carbonylation. Significant price increases in these raw materials directly translate to higher production costs for acetic acid, which generally leads to increased pricing for the final product.

Citations

[1] Celanese Corporation. (n.d.). Products. Retrieved from [Official Celanese Website - Specific product pages for Acetic Acid]

[2] Eastman Chemical Company. (n.d.). Acetyls. Retrieved from [Official Eastman Chemical Website - Specific product pages for Acetic Acid]

[3] LyondellBasell Industries N.V. (n.d.). Products & Services. Retrieved from [Official LyondellBasell Website - Specific product pages for Acetic Acid]

[4] Amneal Pharmaceuticals LLC. (n.d.). API Products. Retrieved from [Official Amneal Pharmaceuticals Website - API Section]

[5] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [Official Teva Pharmaceutical Website - API Section]

[6] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from [FDA Website - Relevant guidance documents on GMP and Drug Master Files]

[7] European Medicines Agency. (n.d.). Scientific Guidelines. Retrieved from [EMA Website - Relevant guidelines on GMP and API manufacturing]