LOCOID LIPOCREAM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Precision Dermat	LOCOID LIPOCREAM	hydrocortisone butyrate	CREAM;TOPICAL	020769	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-384-45	1 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBE	2013-07-03
Precision Dermat	LOCOID LIPOCREAM	hydrocortisone butyrate	CREAM;TOPICAL	020769	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-384-60	1 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBE	2013-07-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

LOCOID LIPOCREAM, a topical corticosteroid formulation primarily used to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis, relies on a complex supply chain to ensure consistent manufacturing and availability. As a potent medication, sourcing high-quality active pharmaceutical ingredients (APIs), excipients, and finished product manufacturing services is critical. This comprehensive overview explores the key suppliers involved in the production of LOCOID LIPOCREAM, including API manufacturers, excipient providers, formulation partners, and distribution channels, with insights into market dynamics, compliance standards, and strategic sourcing considerations.

Active Pharmaceutical Ingredient (API) Suppliers

Hydrocortisone Butyrate API

LOCOID LIPOCREAM contains hydrocortisone butyrate as the active component. Its quality, purity, and regulatory approval heavily influence the drug’s safety and efficacy.

Key Suppliers:

Corden Pharma
A prominent European API producer, Corden Pharma manufactures hydrocortisone butyrate adhering to cGLP and cGMP standards, serving global pharmaceutical companies [1].
Hikma Pharmaceuticals
With international manufacturing facilities, Hikma supplies hydrocortisone derivatives, including hydrocortisone butyrate, focusing on high-quality standards suitable for topical formulations [2].
Sigma-Aldrich (Merck Group)
Although predominantly a chemical supplier, Sigma-Aldrich offers research-grade hydrocortisone butyrate that can be scaled for clinical use, with some suppliers transitioning into GMP-grade production routes [3].
Synthesis and Custom API Makers:
Several smaller, specialized manufacturers in India and China, such as Sun Pharma and Zhejiang Xingning Pharmaceutical, manufacture hydrocortisone butyrate under strict quality control to serve regional and global markets [4].

Market Considerations:

API sourcing requires rigorous quality assurance to prevent impurities that could cause adverse reactions. Regulatory approvals (FDA, EMA, etc.) are pivotal, with manufacturers holding certifications such as ISO 9001 and GMP compliance.

Excipients and Formulation Components

LOCOID LIPOCREAM’s formulation includes various excipients like emollients, preservatives, stabilizers, and emulsifiers, all sourced from specialized suppliers.

Emollients and Lipids:

BASF
Supplies pharmaceutical-grade stearic acid, glyceryl stearate, and other lipids essential for the cream's emollient base [5].
Croda International
Offers a range of fatty alcohols, emulsifiers, and ester derivatives suited for topical formulations, emphasizing stability and skin compatibility [6].

Preservatives and Antioxidants:

Evonik Industries
Provides preservatives like parabens and antioxidants such as butylated hydroxytoluene (BHT), with stringent purity standards aligned with pharmacopeia requirements [7].
Dow Chemical
Supplies preservative agents and stabilizers used to prolong shelf life and maintain formulation integrity.

Other Excipient Suppliers:

Ashland Global Holdings
Offers humectants, thickening agents, and stabilizers crucial for the cream’s consistency and shelf stability [8].

Formulation Development and Manufacturing Partners

Manufacturing LOCOID LIPOCREAM involves specialized formulation facilities complying with GMP standards. Several pharmaceutical contract manufacturers (CMOs) serve as critical partners.

Top Global CMOs:

Recipharm (Sweden):
Specializes in topical and dermatological formulations, offering development, scale-up, and manufacturing expertise for creams and ointments [9].
Alpharma (India):
Known for dermatological product manufacturing, encompassing lipophilic creams such as LOCOID LIPOCREAM, supported by robust quality control systems [10].
Famar (Greece):
Provides manufacturing services for topical corticosteroid formulations, often working under licensing agreements with pharmaceutical companies [11].

Regional CMOs:

Many regional players in India, China, and Eastern Europe offer cost-effective manufacturing options that meet regulatory compliance, facilitating global distribution.

Distribution and Supply Chain Partners

Ensuring that LOCOID LIPOCREAM reaches global markets requires reliable distribution channels.

Distribution Partners Include:

McKesson and Cardinal Health (U.S.):
Major pharmaceutical distributors with extensive networks to supply dermatological drugs across hospitals, clinics, and pharmacies.
Global Generics and Brand Distributors:
Suppliers such as Teva and Sandoz distribute LOCOID LIPOCREAM in multiple regions, complying with regional regulatory requirements.
Regional Wholesalers:
Local distributors in Asia, Africa, and Latin America play essential roles in market penetration and inventory management.

Regulatory and Quality Assurance Considerations

Sourcing from GMP-compliant suppliers and maintaining strict quality assurance protocols are fundamental to preventing product recalls and ensuring patient safety. Regulatory authorities require comprehensive documentation, stability data, and certificates of analysis (COA) from all suppliers.

Certifications to Prioritize:
- GMP Certification
- ISO 9001 Certification
- Certificate of Suitability (CEP) for APIs
- Regulatory filings with FDA, EMA, and equivalent national agencies

Strategic Sourcing and Market Dynamics

The global API market for corticosteroids is characterized by concentrated manufacturing, mainly in India, China, and Europe, which influences pricing and supply stability. Recent supply chain disruptions, pandemic-related challenges, and geopolitical tensions have accentuated the need for diversified sourcing strategies.

Emerging trends include:

Vertical Integration:
Companies increasingly invest in in-house API and excipient manufacturing to secure supply chains.
Quality Upgrades:
Suppliers invest in compliance and certification upgrades to meet stringent international regulations.
Regional Supply Chains:
Expansion of regional suppliers to reduce reliance on distant manufacturing hubs.

Conclusion

The production of LOCOID LIPOCREAM involves a complex network of high-quality API suppliers, excipient vendors, formulation experts, and distribution partners. Ensuring the therapeutic efficacy and safety of this dermatological corticosteroid requires meticulous selection of partners adhering to international regulatory standards. As demand for topical corticosteroids continues to grow globally, active supplier management and strategic sourcing will remain critical for manufacturers seeking to maintain supply continuity and competitive advantage.

Key Takeaways

Primary API providers for hydrocortisone butyrate include Corden Pharma, Hikma, and specialized regional manufacturers, all requiring rigorous GMP compliance.
Excipients are sourced from leading chemical suppliers like BASF and Croda, emphasizing purity and skin compatibility.
Contract manufacturing organizations with proven dermatological expertise are essential for scaling up production while maintaining quality.
Robust distribution networks ensure broad access but require careful partner selection focused on regulatory compliance.
Diversification and regional sourcing strategies mitigate risks posed by supply chain disruptions, supporting stable supply and regulatory adherence.

FAQs

What are the main raw materials required for LOCOID LIPOCREAM?
The key raw materials include hydrocortisone butyrate (API), emollients, emulsifiers, stabilizers, preservatives, and other excipients sourced from certified suppliers.
How do regulatory standards impact supplier choice for LOCOID LIPOCREAM?
Suppliers must hold GMP certification and comply with international standards to ensure product safety, efficacy, and regulatory approval in target markets.
Are regional suppliers viable alternatives to global brands for API and excipients?
Yes, regional suppliers can provide cost-effective and timely options, provided they meet pharmaceutical quality standards and regulatory requirements.
What strategic factors influence the selection of manufacturing partners?
Factors include expertise in dermatological formulations, regulatory compliance, capacity scalability, quality control, and geographic location for distribution efficiency.
How has global supply chain disruption affected the sourcing of LOCOID LIPOCREAM components?
Disruptions have underscored the importance of diversified sourcing, local manufacturing capabilities, and maintaining buffer stocks to ensure continuous supply.

Sources

[1] Corden Pharma Official Website. (2023). API Manufacturing Capabilities.
[2] Hikma Pharmaceuticals Annual Report. (2022). API Sourcing and Manufacturing.
[3] Sigma-Aldrich. (2023). Pharmaceutical-Grade Hydrocortisone Butyrate.
[4] Indian API Manufacturers Directory. (2022). Hydrocortisone Derivatives.
[5] BASF Pharmaceutical Excipients Catalogue. (2022). Emollients and Stabilizers.
[6] Croda International. (2023). Topical Formulation Ingredients.
[7] Evonik Industries. (2023). Preservatives and Antioxidants for Pharmaceuticals.
[8] Ashland Global Holdings. (2022). Cosmetic and Pharmaceutical Stabilizers.
[9] Recipharm Official Website. (2023). Contract Manufacturing Services.
[10] Alpharma India Private Ltd. (2022). Dermatological Formulation Capabilities.
[11] Famar Group. (2023). Topical Pharmaceutical Manufacturing.

Suppliers and packagers for LOCOID LIPOCREAM