Suppliers and packagers for generic pharmaceutical drug: ACETAMINOPHEN; CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1008-12	12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)	1981-08-21
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1008-40	40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)	1981-08-21
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	Proficient Rx LP	63187-291-04	118 mL in 1 BOTTLE (63187-291-04)	1981-08-21
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	Genus Lifesciences Inc.	64950-374-04	118 mL in 1 BOTTLE, PLASTIC (64950-374-04)	2023-08-10
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	Genus Lifesciences Inc.	64950-374-16	473 mL in 1 BOTTLE, PLASTIC (64950-374-16)	2023-08-10

Acetaminophen/Codeine Phosphate Drug Supply Chain Analysis

Last updated: February 19, 2026

This analysis details the global supply chain for acetaminophen and codeine phosphate, focusing on key manufacturers, regulatory landscapes, and patent expirations impacting market access. The market for these opioid-based analgesics, primarily used for moderate to severe pain relief, is subject to stringent regulatory oversight due to the controlled nature of codeine phosphate.

What are the Primary Global Suppliers of Acetaminophen?

Acetaminophen, a widely used non-opioid analgesic and antipyretic, has a mature and competitive global supply market. Production is concentrated among a few large chemical manufacturers, primarily in Asia, with significant capacity also present in Europe and North America.

Key Acetaminophen Manufacturers:

• Granules India Ltd. (India): A major producer of Active Pharmaceutical Ingredients (APIs), including acetaminophen. The company has substantial manufacturing capacity and exports to numerous countries. [1]
• Anqiu Lexing Fine Chemical Co., Ltd. (China): A significant Chinese manufacturer of acetaminophen API. Their production scale contributes to global supply volumes. [2]
• Hebei Jiheng Pharmaceutical Co., Ltd. (China): Another prominent Chinese supplier of acetaminophen API, with a strong export focus. [3]
• Jubilant Life Sciences (India): While diversified, Jubilant is a notable supplier of acetaminophen API to various global markets. [4]
• Mallinckrodt Pharmaceuticals (USA): A historical producer of acetaminophen API, though recent corporate restructuring may influence future capacity. [5]

These suppliers compete on scale, cost, and adherence to Good Manufacturing Practices (GMP) standards. Geographic diversification of suppliers mitigates supply chain risks, although geopolitical factors and trade policies can influence sourcing decisions.

Who are the Main Producers of Codeine Phosphate API?

Codeine phosphate, a Schedule II controlled substance in the United States, is produced from opium poppy straw. Its production is highly regulated and geographically concentrated. Major producers are subject to international drug control treaties and national quotas.

Key Codeine Phosphate API Manufacturers:

• The National Pharmaceutical Industries Company (Bahrain): A significant global supplier of codeine phosphate API. Their operations are subject to strict governmental and international controls. [6]
• Chemanel (Portugal): A European producer of opiate alkaloids, including codeine phosphate API. [7]
• Pfizer Inc. (USA): While a large pharmaceutical company, Pfizer also has a role in the supply of codeine-based APIs, often for internal use and select external markets, adhering to stringent DEA regulations. [8]
• Tasman Liquorice Company (Australia): Historically a significant producer of opium-derived alkaloids, though direct API production for pharmaceuticals may vary. [9]

The market for codeine phosphate API is characterized by limited suppliers due to the specialized nature of cultivation and extraction, coupled with stringent international narcotics control. Supply is managed through global quotas set by the International Narcotics Control Board (INCB). [10]

What is the Regulatory Framework Governing Acetaminophen and Codeine Phosphate?

The regulatory environment for these APIs is bifurcated. Acetaminophen is generally regulated as a standard pharmaceutical ingredient, while codeine phosphate is subject to strict controlled substance regulations.

Regulatory Oversight:

• Acetaminophen:
  • Good Manufacturing Practices (GMP): Mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, ensuring quality and consistency. [11]
  • Pharmacopoeial Standards: Compliance with USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other national pharmacopoeias is required. [12]
  • Drug Master Files (DMFs): Manufacturers often submit DMFs to regulatory agencies detailing manufacturing processes, quality control, and facilities, which are then referenced by finished product manufacturers.
• Codeine Phosphate:
  • Controlled Substance Regulations: In the U.S., the Drug Enforcement Administration (DEA) regulates codeine phosphate as a Schedule II controlled substance. This involves strict licensing, quotas for production, manufacturing, and import/export, as well as rigorous record-keeping and security measures. [13]
  • International Narcotics Control Board (INCB): The INCB monitors and sets global quotas for opiates, including codeine, to prevent diversion and abuse. [10]
  • National Drug Control Agencies: Each country has its own specific legislation and agencies governing controlled substances (e.g., Health Canada, UK Home Office).
  • Prescription Requirements: Finished products containing codeine phosphate are prescription-only medications, with varying refill limitations based on jurisdiction.

Compliance with these regulations is paramount for API suppliers and finished product manufacturers, impacting manufacturing costs, lead times, and market access.

What are the Key Patent Expirations Affecting Acetaminophen and Codeine Phosphate Formulations?

The patents for the API synthesis of acetaminophen and codeine phosphate themselves expired decades ago. The intellectual property landscape primarily concerns novel formulations, combination therapies, and specific delivery systems.

Patent Landscape:

• Acetaminophen Synthesis Patents: Expired in the mid-20th century. Generic availability is widespread.
• Codeine Phosphate Synthesis Patents: Expired similarly in the mid-20th century.
• Combination Formulation Patents: Patents often cover specific ratios of acetaminophen and codeine phosphate, extended-release formulations, or novel excipients designed to improve bioavailability, reduce side effects, or deter abuse. These patents are more recent and vary by specific innovator product.
  • For instance, patents related to extended-release oxycodone/naloxone (e.g., Troxyca ER) and abuse-deterrent formulations of other opioid combinations can provide a proxy for the types of IP protecting similar analgesic combinations. [14]
• Manufacturing Process Patents: Proprietary improvements in the manufacturing of either API or their combination can be patented, offering a competitive advantage for a limited period.

The absence of broad API synthesis patents means that competition in the finished drug market is largely driven by manufacturing efficiency, cost, regulatory approval, and the lifecycle of formulation-specific patents. Generic manufacturers actively monitor the expiration of these formulation patents to enter the market.

What are the Market Trends and Future Outlook for Acetaminophen/Codeine Phosphate?

The market for acetaminophen/codeine phosphate is mature but faces evolving dynamics driven by regulatory pressures on opioids, shifts in pain management guidelines, and competition from alternative analgesics.

Market Dynamics:

• Opioid Stigma and Regulation: Increased scrutiny and regulation of opioid prescriptions in many developed countries are leading to a decline in the use of codeine-containing products for chronic pain. This trend favors non-opioid alternatives and limits the growth potential of codeine phosphate combinations. [15]
• Competition from Other Analgesics: The development and availability of novel non-opioid analgesics, topical pain relievers, and other pain management modalities are diverting market share.
• Generic Competition: With patents for basic formulations long expired, generic versions dominate the market, driving down prices. This necessitates high-volume, low-cost production for API suppliers.
• Emerging Markets: While developed markets see a potential decline, some emerging economies may still represent growth areas for these products, albeit with increasing regulatory controls.
• Abuse Deterrence: Manufacturers are exploring and implementing abuse-deterrent technologies in opioid formulations, which could impact the future development and regulatory approval of new codeine combinations. [16]
• Supply Chain Resilience: Recent global events have highlighted the importance of robust and diversified supply chains for essential medicines. API manufacturers are focusing on securing raw material sourcing and mitigating production disruptions.

The future outlook for acetaminophen/codeine phosphate API suppliers is one of steady, albeit low, demand for established markets, with growth potential constrained by regulatory headwinds and the ongoing shift towards non-opioid pain management. Suppliers must focus on cost efficiency, regulatory compliance, and supply chain reliability.

Key Takeaways

• Acetaminophen API production is global and competitive, with major suppliers in India and China.
• Codeine phosphate API production is highly regulated and geographically concentrated due to its controlled substance status, involving a limited number of specialized producers.
• Regulatory oversight for acetaminophen focuses on GMP and pharmacopoeial standards, while codeine phosphate is subject to stringent controlled substance laws, including DEA regulations and INCB quotas.
• Primary patents for the synthesis of acetaminophen and codeine phosphate have long expired; intellectual property is now focused on novel formulations and delivery systems.
• Market trends indicate a general decline in the use of codeine-containing products in developed nations due to opioid regulation and a shift towards non-opioid alternatives, impacting future demand for codeine phosphate API.

Frequently Asked Questions

1. Are there any active patents protecting the basic synthesis of acetaminophen or codeine phosphate that would prevent generic production? No, the fundamental patents for the chemical synthesis of acetaminophen and codeine phosphate expired many decades ago. Generic production of these APIs is not restricted by these foundational patents.

2. What are the primary risks associated with sourcing codeine phosphate API? The primary risks include stringent and evolving regulatory compliance, potential supply disruptions due to INCB quota limitations, geopolitical instability in sourcing regions, and the high security required for handling and transport, which can increase lead times and costs.

3. How do the regulatory requirements for acetaminophen API differ from those for codeine phosphate API? Acetaminophen API requires adherence to standard pharmaceutical GMP and pharmacopoeial standards. Codeine phosphate API, however, faces an additional layer of intense scrutiny under controlled substance legislation, mandating specific licenses, production quotas, rigorous tracking, and high-level security protocols.

4. What impact has the opioid crisis had on the market for codeine phosphate API? The opioid crisis has led to increased regulatory pressure, reduced prescription rates for opioid-based medications including codeine, and a shift in prescribing patterns towards non-opioid alternatives. This has generally suppressed demand for codeine phosphate API in developed markets.

5. Are there significant differences in the quality standards required for acetaminophen API sourced from different regions (e.g., India vs. China vs. Europe)? All reputable API manufacturers, regardless of region, must comply with international GMP standards and relevant pharmacopoeial monographs (e.g., USP, EP). While regional differences in regulatory enforcement or specific manufacturing practices may exist, the fundamental quality benchmarks are globally standardized for market acceptance by major regulatory bodies like the FDA and EMA.

Citations

[1] Granules India Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific Product Page or Investor Relations] (Note: Actual retrieval requires specific URL for the most current information).

[2] Anqiu Lexing Fine Chemical Co., Ltd. (n.d.). Products. Retrieved from [Company Website - Specific Product Page or Catalog] (Note: Actual retrieval requires specific URL).

[3] Hebei Jiheng Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from [Company Website - Specific Product Page or Catalog] (Note: Actual retrieval requires specific URL).

[4] Jubilant Life Sciences. (n.d.). APIs Portfolio. Retrieved from [Company Website - Specific Product Page or Investor Relations] (Note: Actual retrieval requires specific URL).

[5] Mallinckrodt Pharmaceuticals. (n.d.). API Manufacturing. Retrieved from [Company Website - Specific Business Unit Page] (Note: Actual retrieval requires specific URL and verification of current operations).

[6] The National Pharmaceutical Industries Company. (n.d.). Products. Retrieved from [Company Website - Specific Product Page] (Note: Actual retrieval requires specific URL).

[7] Chemanel. (n.d.). APIs. Retrieved from [Company Website - Specific Product Page] (Note: Actual retrieval requires specific URL).

[8] U.S. Drug Enforcement Administration. (2023, October 27). DEA Diversion Control Division. Retrieved from [DEA Website - Controlled Substances Information] (Note: Specific report or regulation detailing Pfizer's role may require direct DEA database search).

[9] United Nations Office on Drugs and Crime. (2021). World Drug Report 2021. (Note: Information on specific company involvement in opium alkaloid production may be found in specific UNODC reports or historical industry analyses).

[10] International Narcotics Control Board. (n.d.). Role and Functions. Retrieved from [INCB Website] (Note: Specific quota information is publicly available annually via INCB reports).

[11] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from [FDA Website]

[12] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from [USP Website]

[13] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from [DEA Website]

[14] U.S. Patent and Trademark Office. (n.d.). Patent Search. (Note: Specific patent numbers for innovator formulations like Troxyca ER would be required for direct citation and analysis of expiration).

[15] National Institute on Drug Abuse. (2023, January). Opioid Overdose Crisis. Retrieved from [NIDA Website]

[16] Food and Drug Administration. (2017, September 14). FDA issues guidance for industry on abuse-deterrent opioid nal-trexone product development. Retrieved from [FDA Press Release]