CODEINE SULFATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402	NDA	Hikma Pharmaceuticals USA Inc.	0054-0243-24	10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACK	2009-07-16
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402	NDA	Hikma Pharmaceuticals USA Inc.	0054-0244-24	10 BLISTER PACK in 1 BOX (0054-0244-24) / 10 TABLET in 1 BLISTER PACK	2009-07-16
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402	NDA	Hikma Pharmaceuticals USA Inc.	0054-0244-25	100 TABLET in 1 BOTTLE (0054-0244-25)	2009-07-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 9, 2025

Introduction

Codeine sulfate, a potent opioid analgesic and cough suppressant, remains a critical compound within global pharmaceutical markets. Its controlled status stems from its potential for abuse and dependency, prompting stringent regulatory oversight. Identifying reliable suppliers of pharmaceutical-grade codeine sulfate is vital for drug manufacturers, wholesalers, and healthcare providers seeking compliant, high-quality, and consistent supply. This article comprehensively examines the leading suppliers, sourcing strategies, regulatory considerations, and market dynamics influencing the procurement of codeine sulfate internationally.

Market Overview and Regulatory Landscape

Codeine sulfate is classified under controlled substances due to its analgesic and antitussive properties. The International Narcotics Control Board (INCB) and national agencies—such as the U.S. Drug Enforcement Administration (DEA) and European Medicines Agency (EMA)—regulate its production, distribution, and export. Manufacturers must adhere to rigorous Good Manufacturing Practices (GMP) to maintain quality standards.

Global production is concentrated primarily in a handful of countries with established pharmaceutical manufacturing infrastructure. These include India, China, and certain European nations. However, strict export controls and licensing requirements influence global supply chains.

Key Suppliers of Pharmaceutical-Grade Codeine Sulfate

1. India

India stands as the world's largest producer and exporter of various opiates, including codeine sulfate. Its pharmaceutical industry benefits from cost-effective manufacturing alongside a well-developed API (Active Pharmaceutical Ingredient) sector.

Sun Pharmaceutical Industries Ltd.
As one of India's leading pharmaceutical firms, Sun Pharma produces and supplies pharmaceutical intermediates, including codeine sulfate, adhering to GMP standards. Their extensive distribution network facilitates global reach.
Alembic Pharmaceuticals
Known for its robust API manufacturing capabilities, Alembic supplies high-quality codeine sulfate to international markets under strict regulatory compliance.
Glenmark Pharmaceuticals
Engaged in producing both finished formulations and APIs, Glenmark offers codeine sulfate to international clients, emphasizing quality and regulatory adherence.

Regulatory Note: Indian suppliers must secure export licenses and comply with the Drugs and Cosmetics Act, alongside international certifications such as ISO and WHO-GMP.

2. China

China serves as a significant supplier, with many drug ingredient manufacturers specializing in opiates. The country’s API sector is characterized by large-scale production facilities, often exporting to developed markets.

North China Pharmaceutical Group Corporation (NCPC)
A key producer of APIs, including codeine sulfate, servicing global pharmaceutical firms.
Shandong Xinhua Pharmaceutical Co., Ltd.
Supplies pharmaceutical intermediates and APIs, maintaining GMP certification and export permits, catering to global demands.
Jiangxi Jinzhun Pharmaceutical Co., Ltd.
Known for compliance with OECD Good Manufacturing Practices and exporting diverse chemical intermediates.

Regulatory Note: Chinese suppliers are subject to export restrictions, licensing, and international monitoring regarding controlled substances. Their compliance with OECD GMP standards is vital for global acceptance.

3. Europe

European suppliers, although fewer, focus on high-quality, GMP-certified codeine sulfate suitable for pharmaceutical applications.

Vianex S.A. (Greece)
Supplies APIs and finished products, including codeine sulfate, with adherence to EMA standards.
Daiichi Sankyo (Japan/Europe)
Engages in global API supply, including codeine derivatives, with rigorous quality control systems.

Regulatory Note: European suppliers operate under EMA regulations, and products require CE marking and adherence to EudraLex standards.

Emerging and Niche Suppliers

Some specialty chemical companies focus on niche or custom synthesis of codeine sulfate for research and pharmaceutical formulations. These include smaller, GMP-compliant entities in North America and other regions.

Searle Pharmaceuticals (United States) – Limited, with strict compliance to DEA regulations for controlled substances.
CMIC Group (Japan) – Focused on research-grade intermediates, including controlled substances.

Sourcing Strategies and Due Diligence

Due to the sensitive nature of codeine sulfate, sourcing must prioritize regulatory compliance, quality control, and consistent supply. Establishing partnerships with suppliers holding ISO, WHO-GMP, or equivalent certifications is imperative. Verifying suppliers’ licenses for controlled substances, such as DEA registration or equivalent, is mandatory.

International procurement involves navigating complex import-export regulations, especially in jurisdictions with stringent controlled substance controls. Engaging with experienced customs brokers and legal consultants can mitigate compliance risks.

Challenges and Risks

Regulatory Restrictions: Stringent controls can delay procurement or restrict supply, especially during geopolitical shifts or policy changes.
Supply Chain Disruptions: Political instability, export bans, or manufacturing shutdowns impact availability.
Quality Variability: Not all suppliers maintain consistent quality, underscoring the importance of audits and certification checks.
Price Volatility: Regulatory environments and production costs influence pricing, requiring careful market analysis.

Concluding Market Outlook

The global supply of pharmaceutical-grade codeine sulfate is characterized by robust production hubs in India and China, with European suppliers offering high-regulatory compliance options. Ongoing regulatory scrutiny demands diligent vetting, quality assurance, and compliance to ensure a reliable and lawful supply pipeline. Market dynamics continue to evolve, influenced by drug regulatory policies, international law enforcement, and advancements in synthetic alternatives.

Key Takeaways

India and China dominate the global supply chain for pharmaceutical-grade codeine sulfate, supported by extensive API manufacturing capabilities.
Regulatory compliance, including GMP certification and proper licensing, is critical to sourcing high-quality codeine sulfate.
Due diligence in supplier audits, certifications, and legal compliance minimizes risks associated with controlled substances.
Supply chain disruptions may arise from regulatory changes, geopolitical tensions, or manufacturing issues, necessitating diversified sourcing strategies.
Ongoing monitoring of international policies and market developments is essential for maintaining a secure supply and optimizing procurement costs.

FAQs

1. Are all suppliers of codeine sulfate compliant with international regulations?
No. Only suppliers with proper certifications such as GMP, ISO, and necessary licensing—like DEA registration—are compliant. Buyers must verify certification and licensing prior to procurement.

2. How can companies ensure the quality of the codeine sulfate supplied?
By sourcing from validated suppliers with accredited certifications, conducting regular audits, requesting quality assurance documentation, and performing independent testing or third-party audits.

3. What are the primary regulatory considerations when importing codeine sulfate?
Compliance with national drug control laws, proper licensing, adherence to import/export permits, and meeting certification standards like GMP and ISO are crucial.

4. Is synthetic production of codeine sulfate possible, or is it exclusively derived from opium poppies?
While traditionally derived from opium poppies, alternative synthetic routes are under research, but most pharmaceutical-grade codeine sulfate is still sourced from natural opiates due to established manufacturing processes.

5. How do geopolitical factors influence the supply of codeine sulfate?
Trade restrictions, sanctions, and policy changes in producing or transit countries can disrupt supply chains and affect availability, emphasizing the need for diversified sourcing and contingency planning.

Sources:

[1] International Narcotics Control Board (INCB), Annual Reports, 2022.
[2] U.S. Drug Enforcement Administration (DEA), Controlled Substances Final Rule, 2021.
[3] World Health Organization (WHO), Guidelines for the Manufacture of Pharmaceutical Excipients, 2020.
[4] Indian Pharmaceuticals Export Promotion Council (Pharmexcil), Industry Reports, 2022.
[5] European Medicines Agency (EMA), Regulations on Controlled Substances, 2022.

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