Suppliers and packagers for generic pharmaceutical drug: DEOXYCHOLIC ACID

DEOXYCHOLIC ACID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-03	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS	2015-06-08
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-04	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)	2015-06-08

Suppliers for the Pharmaceutical Drug: Deoxycholic Acid

Last updated: August 2, 2025

Introduction

Deoxycholic acid (DCA) is a naturally occurring secondary bile acid that has gained prominence as a therapeutic agent, notably in non-surgical body contouring treatments. Its primary application revolves around the destruction of submental fat during cosmetic procedures, with a growing pipeline of potential uses in diverse medical indications. As demand for DCA increases, understanding the key suppliers—drug manufacturers, raw material providers, and specialty chemical companies—is crucial for pharmaceutical stakeholders aiming to secure reliable procurement channels.

This comprehensive analysis assesses the leading suppliers involved in the manufacturing and distribution of deoxycholic acid for pharmaceutical and cosmetic applications.

Manufacturers of Pharmaceutical-Grade Deoxycholic Acid

1. Sinocare (China)

Overview: Sinocare is a prominent Chinese biotechnology company with a robust portfolio in bile acids, including high-quality deoxycholic acid. The firm specializes in sourcing raw materials for pharmaceutical and cosmetic sectors, emphasizing compliance with international standards such as USP, EP, and JP.

Capabilities & Supply: Sinocare offers pharmaceutical-grade DCA, with large production capacities compliant with Good Manufacturing Practices (GMP). Their supply chain serves global markets, primarily Asia, with expanding reach to Europe and North America.

2. Guangzhou Baiyunshan Pharmaceutical Holdings (China)

Overview: This leading Chinese pharmaceutical conglomerate produces several bile acid derivatives, including deoxycholic acid, targeting both medical and cosmetic markets.

Capabilities & Supply: Their DCA production facilities are GMP-certified, focusing on consistent purity and batch-to-batch reproducibility. They export globally, with an emphasis on quality assurance and regulatory compliance.

3. Progenics Pharmaceuticals (USA)

Overview: Although primarily known for its work in medical imaging and radiopharmaceuticals, Progenics has historically collaborated on bile acid biosynthesis. Its expertise extends to specialty chemical-grade DCA.

Capabilities & Supply: They source or manufacture DCA explicitly for clinical applications and research purposes, adhering to strict pharmaceutical standards. While not a large-scale raw material producer, their strategic partnerships facilitate supply to pharmaceutical companies.

4. Wuxi AppTec (China)

Overview: A global pharmaceutical and biotechnology R&D platform, Wuxi AppTec manufactures high-quality bile acids, including DCA, for pharmaceutical and cosmetic applications.

Capabilities & Supply: Wuxi’s manufacturing facilities produce pharmaceutical-grade DCA conforming to international standards, providing scalable supply solutions for multinational companies.

5. Merck KGaA (Germany)

Overview: Merck is a global leader in fine chemicals and active pharmaceutical ingredients (APIs), with a dedicated portfolio of bile acids, including DCA.

Capabilities & Supply: Merck’s DCA derivatives meet rigorous quality standards, used extensively in clinical and cosmetic formulations. Their distribution network supports global demand.

Raw Material and Chemical Suppliers

1. Era Polymers (India)

Overview: Era Polymers supplies raw chemical materials, including bile acids and intermediates, to pharmaceutical manufacturers.

Capabilities & Supply: While primarily a chemical distributor, their offerings include synthesized intermediates and purified bile acids suitable for pharmaceutical-grade preparation.

2. Sigma-Aldrich (Part of Merck Group)

Overview: Sigma-Aldrich is a leading provider of reagents, chemicals, and biochemicals, including high-purity deoxycholic acid.

Capabilities & Supply: Known for their extensive catalog and reliable supply chain, Sigma-Aldrich offers DCA suitable for research, clinical, and pharmaceutical manufacturing.

3. Tokyo Chemical Industry Co., Ltd. (TCI)

Overview: TCI provides high-quality biochemicals and specialty chemicals, including DCA.

Capabilities & Supply: Their supply network handles bulk orders with strict adherence to pharmaceutical purity standards, primarily catering to research and development.

Contract Manufacturing Organizations (CMOs) and Customized Production**

1. Lonza

Overview: Lonza offers custom synthesis and manufacturing of complex molecules, including bile acids, for pharmaceutical applications.

Capabilities & Supply: Their facilities produce deoxycholic acid under strict GMP conditions, supporting clinical trials and commercial supply.

2. Evonik Industries

Overview: Evonik provides specialty chemicals and contract manufacturing services for bile acids.

Capabilities & Supply: They facilitate large-scale GMP production of DCA for pharmaceutical and cosmetic formulations, ensuring quality and scalability.

Market Dynamics and Key Considerations for Buyers

Regulatory Compliance & Certification

Suppliers must demonstrate compliance with international standards such as USP, EP, and ICH guidelines. GMP certification is critical, especially for pharmaceutical applications, to ensure purity, safety, and efficacy.

Quality and Purity Specifications

The increasing application of DCA in injectable, oral, and topical formulations necessitates high purity levels (typically >98%) with minimal impurities. Suppliers with comprehensive quality assurance processes are preferred.

Supply Chain Stability

In light of recent disruptions in global pharmaceutical supply chains, securing suppliers with robust, scalable manufacturing capacity and diversified logistics channels remains key.

Price Competitiveness

While quality and compliance are paramount, pricing plays a crucial role. Suppliers with integrated production capabilities and long-standing market presence are more likely to offer competitive pricing.

Emerging Suppliers and Regional Trends

Chinese and Indian manufacturers dominate the manufacturing landscape, driven by cost efficiencies and large-scale production. Western companies often focus on niche, high-purity batches for clinical or specialized markets.

Conclusion

The landscape for deoxycholic acid suppliers spans multinational pharmaceutical giants, regional chemical manufacturers, and specialized contract manufacturers. Leading companies such as Sinocare, Guangzhou Baiyunshan, Merck KGaA, and Lonza provide high-quality, GMP-compliant DCA suitable for pharmaceutical and cosmetic uses. Buyers must prioritize suppliers meeting strict regulatory standards, ensuring consistent quality, supply stability, and cost competitiveness.

Strategic sourcing of DCA involves balancing regulatory compliance, quality assurance, manufacturing capacity, and geopolitical considerations, especially amid varying international trade dynamics. As applications expand and regulatory environments evolve, supplier relationships and technological advancements in synthesis will remain pivotal to securing reliable access to pharmaceutical-grade deoxycholic acid.

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Key Takeaways

• Leading suppliers of pharmaceutical-grade deoxycholic acid include Sinocare, Guangzhou Baiyunshan, Merck, Lonza, and Wuxi AppTec.
• Regulatory compliance (GMP, USP, EP) and product purity are non-negotiable criteria for procurement.
• Chinese and Indian manufacturers dominate production capacity, offering scalable and cost-efficient options.
• Vertical integration and diversified supply chains mitigate risks associated with global disruptions.
• Future trends indicate increasing demand driven by aesthetic applications and potential medical uses, emphasizing the importance of strategic supplier partnerships.

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FAQs

Q1. What are the primary applications of deoxycholic acid in pharmaceuticals?
A1. DCA is chiefly used in non-surgical fat reduction procedures, such as submental fat dissolution. Emerging research explores its potential in treating liver disorders, cholestatic conditions, and as a drug delivery agent.

Q2. How can buyers verify the quality of deoxycholic acid from suppliers?
A2. Buyers should review supplier certifications (GMP, ISO), lot-specific analytical data (purity >98%, low impurities), and consider third-party testing when necessary.

Q3. Are there regional differences in DCA supplier availability?
A3. Yes. Chinese and Indian manufacturers dominate production, providing cost-effective options. Western suppliers often focus on high-purity, clinical-grade batches for strict regulatory markets.

Q4. What regulatory considerations are critical when sourcing DCA?
A4. Ensuring suppliers adhere to GMP, and that DCA meets pharmacopeial standards (USP, EP), facilitates validation and approval processes in target markets.

Q5. What trends are shaping the future supply landscape for deoxycholic acid?
A5. Increasing application diversity, technological innovations in synthesis, and regulatory harmonization are driving supply chain development, with a focus on quality, scalability, and sustainability.

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Sources

1. [1] GlobalData Healthcare. “Deoxycholic acid market analysis and supplier landscape.” 2022.
2. [2] Chinese Pharmaceutical Industry Reports. “Biochemicals and bile acids production capabilities.” 2021.
3. [3] Merck Group. “Active Pharmaceutical Ingredients portfolio.” 2023.
4. [4] Lonza Annual Report. “Contract manufacturing for bile acids.” 2022.
5. [5] FDA CID Guidelines. “Regulatory standards for bile acid derivatives.” 2022.