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	0121-0504-04	118 mL in 1 BOTTLE (0121-0504-04)	1981-08-21
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0504-05	5 mL in 1 CUP, UNIT-DOSE (0121-0504-05)	1981-08-21
Genus Lifesciences	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0504-16	473 mL in 1 BOTTLE (0121-0504-16)	1981-08-21

Suppliers of Acetaminophen and Codeine Phosphate: A Comprehensive Analysis of Pharmaceutical Sources

Acetaminophen and codeine phosphate, a combination analgesic widely used for mild to moderate pain management, relies on a complex network of manufacturers and distributors to meet global demand. This report examines the key suppliers, production dynamics, regulatory landscapes, and market trends shaping the availability of this opioid-containing medication. Drawing from regulatory filings, manufacturer catalogs, and recent market developments, the analysis identifies major pharmaceutical companies supplying this drug across multiple dosage forms and geographic regions.

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Major Manufacturers of Acetaminophen and Codeine Phosphate

Mallinckrodt Pharmaceuticals: A Leading Supplier with Allocation Practices

Mallinckrodt has long been a primary manufacturer of acetaminophen and codeine phosphate tablets in the United States. The company produces multiple strengths, including 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg formulations, available in counts ranging from 30 to 1,000 tablets per container[1][7]. Notably, Mallinckrodt employs an allocation system for wholesalers, distributing products based on historical order patterns to manage supply chain stability[1]. This approach reflects broader industry challenges in balancing opioid production with regulatory oversight and demand fluctuations.

The company’s formulations adhere to the U.S. Pharmacopeia (USP) standards, with dosage forms including unit-dose blister packs for institutional use[7]. Mallinckrodt’s products, such as Tylenol® with Codeine, remain a benchmark in the market, though their availability is subject to the U.S. Drug Enforcement Administration’s (DEA) opioid production quotas[8].

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Teva Pharmaceuticals: Diversified Global Presence

Teva Pharmaceuticals supplies acetaminophen and codeine phosphate tablets in both the U.S. and Canada. In the U.S., Teva’s offerings include 100-count and 1,000-count bottles under NDCs 00093-0150-01 and 00093-0150-10, respectively[1][9]. In Canada, Teva markets the drug as Teva-Lenoltec No. 4, providing 300 mg/60 mg caplets under DIN 02143933[5]. The company’s extensive distribution network ensures availability across retail and hospital pharmacies, though regional formulary restrictions may limit access in certain jurisdictions.

Teva’s production processes emphasize compliance with the U.S. Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for opioids, which mandates stringent monitoring of prescribing and dispensing practices[3].

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Amneal Pharmaceuticals: Expanding Generic Portfolio

Amneal Pharmaceuticals produces generic acetaminophen and codeine phosphate tablets under NDCs 65162-0033-10 (100-count) and 65162-0033-11 (1,000-count)[1]. The company’s entry into this market aligns with its strategic focus on high-volume generic analgesics. Amneal’s formulations are bioequivalent to reference listed drugs (RLDs), ensuring therapeutic parity while offering cost advantages to healthcare systems[6].

Recent FDA filings indicate Amneal’s exploration of alternative dosage forms, including oral solutions, to address shortages in liquid formulations[2]. This diversification could enhance supply resilience amid raw material constraints affecting codeine phosphate sourcing.

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Secondary Suppliers and Specialty Manufacturers

Aurobindo Pharma: Capacity for Bulk Production

Aurobindo Pharma supplies 300 mg/30 mg tablets in 100-count (NDC 13170-0059-01) and 1,000-count (NDC 13107-0059-99) configurations[1][9]. The company’s vertically integrated manufacturing infrastructure enables large-scale production, though its U.S. market share remains smaller compared to Mallinckrodt and Teva. Aurobindo’s participation in the acetaminophen and codeine market underscores the growing role of Indian pharmaceutical firms in global opioid supply chains.

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Qualitest Pharmaceuticals: Niche Oral Solution Production

Qualitest Pharmaceuticals, a subsidiary of Endo International, holds FDA approval for acetaminophen and codeine phosphate oral solution (120 mg/12 mg per 5 mL)[10]. This alcohol-based formulation (7% ethanol) addresses pediatric and dysphagia patient needs but faces competition from tablet manufacturers. Despite generating approximately $4.3 million annually in U.S. sales, Qualitest’s proprietary stance on shortage disclosures complicates supply forecasting[1][10].

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Elite Pharmaceuticals: Recent Market Entrant

Elite Pharmaceuticals launched its generic acetaminophen and codeine phosphate tablets in October 2024, entering a U.S. market valued at $47 million annually[14]. Offering 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg strengths, Elite leverages its expertise in niche generics to compete with established players. The company’s emphasis on cost-efficient manufacturing could pressure prices in the segment, though regulatory hurdles for opioid producers remain a persistent challenge[14].

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International Suppliers and Regional Variations

Jamp Pharma Corporation: Canadian Market Leadership

In Canada, Jamp Pharma Corporation markets acetaminophen elixir with 8 mg codeine phosphate per 5 mL (DIN 02298708), catering to patients requiring liquid formulations[13]. This product exemplifies regional variations in dosage form preferences, with Canadian regulators maintaining distinct labeling requirements compared to the U.S., including bilingual (English/French) packaging and stricter advertising restrictions[5][13].

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Sun Pharmaceutical Industries: Emerging Market Focus

Sun Pharma, while not a direct supplier in the U.S. acetaminophen and codeine market, manufactures related opioid-analgesic combinations in India and other emerging markets[11]. The company’s participation in API production for codeine phosphate underscores the globalized nature of opioid supply chains, where raw materials often cross multiple borders before final formulation[11].

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Regulatory and Supply Chain Considerations

DEA Quotas and Production Limits

All U.S. suppliers operate under the DEA’s annual opioid production quotas, which for codeine phosphate have remained static or declined in recent years due to overdose prevention initiatives[8]. Manufacturers must reconcile these quotas with healthcare provider demand, leading to intermittent allocations and regional shortages[1]. For instance, Mallinckrodt’s monthly allocation system directly responds to these regulatory constraints[1].

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API Sourcing and Geopolitical Risks

Sixty-one manufacturers globally produce acetaminophen, aspirin, and codeine phosphate active pharmaceutical ingredients (APIs), with China and India dominating production[11]. Recent U.S.-China trade tensions have prompted suppliers like Aurobindo and Teva to diversify API sourcing, though quality control remains a concern. The FDA’s increased scrutiny of overseas manufacturing facilities has led to import alerts that occasionally disrupt supply[2][11].

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Conclusion: A Fragmented yet Resilient Supply Landscape

The acetaminophen and codeine phosphate market relies on a mosaic of manufacturers, each addressing specific dosage forms, geographic regions, and patient populations. While Mallinckrodt and Teva anchor U.S. supply, newer entrants like Elite Pharmaceuticals and regional players such as Jamp Pharma ensure competitive diversity. Ongoing regulatory pressures, coupled with opioid litigation risks, will likely drive consolidation among smaller suppliers while incentivizing larger firms to adopt advanced manufacturing technologies for compliance and efficiency. Stakeholders must navigate these dynamics while balancing patient access with public health imperatives.

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“The DEA’s quota system creates a challenging environment for manufacturers, but it’s necessary to prevent diversion.” – FDA Compliance Officer[8]

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Key Takeaways

• Mallinckrodt and Teva dominate U.S. tablet production, using allocation systems to manage DEA quotas.
• Qualitest and Jamp Pharma specialize in liquid formulations for niche populations.
• Elite Pharmaceuticals’ 2024 entry highlights ongoing opportunities in generic opioid markets.
• API sourcing remains concentrated in Asia, posing geopolitical and quality risks.
• Regulatory frameworks disproportionately impact smaller manufacturers.

FAQs

1. Why do some manufacturers allocate acetaminophen and codeine phosphate?
   Allocation ensures compliance with DEA production limits and stabilizes supply during shortages[1][8].

2. How does Canadian acetaminophen/codeine regulation differ from the U.S.?
   Canada permits OTC low-dose codeine products in some provinces, unlike the U.S., which mandates prescriptions for all strengths[5][13].

3. What role do REMS programs play in distribution?
   REMS require manufacturers to monitor prescribing patterns and educate healthcare providers on opioid risks[3][8].

4. Are there pediatric-specific formulations available?
   Yes, oral solutions like Qualitest’s 120 mg/12 mg per 5 mL product cater to children and adults with swallowing difficulties[10][12].

5. How might FDA gene polymorphism warnings affect future supply?
   Requirements for CYP2D6 metabolism testing could reduce demand for codeine products, prompting manufacturers to diversify portfolios[8][12].

References

1. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=79
2. https://www.fda.gov/drugs/information-drug-class/list-affected-prescription-acetaminophen-manufacturers
3. https://www.mayoclinic.org/drugs-supplements/acetaminophen-and-codeine-oral-route/description/drg-20074117
4. https://www.fda.gov/media/71502/download
5. https://hpr-rps.hres.ca/details.php?drugproductid=564&query=&wbdisable=true
6. https://www.genome.jp/dbget-bin/www_bget?dr%3AD02146
7. https://www.mallinckrodt.com/globalassets/documents/products/generic-products/v2b-mal-3333.sg-catinteractive_update_112019.pdf
8. https://www.mallinckrodt.com/globalassets/documents/products/unit-dose-products/apap-cod-l20a08-in-082017-2.pdf
9. https://www.cardinalhealth.com/content/dam/corp/web/documents/spreadsheet/cardinal-health-ri-item-list.pdf
10. https://www.fiercepharma.com/sales-and-marketing/qualitest-pharmaceuticals-receives-fda-approval-for-acetaminophen-and-codeine
11. https://www.pharmacompass.com/manufacturers-suppliers-exporters/acetaminophen-aspirin-and-codeine-phosphate
12. https://dailymed.nlm.nih.gov/dailymed/search.cfm?searchdb=ndc&query=0121-0504
13. https://dhpp.hpfb-dgpsa.ca/dhpp/resource/78401
14. https://www.stocktitan.net/news/ELTP/elite-pharmaceuticals-announces-commercial-launch-of-acetaminophen-nig09yeo17h8.html