Suppliers and packagers for ALEVE PM

ALEVE PM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352	NDA	Bayer HealthCare LLC.	0280-1200-01	1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE	2014-09-09
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352	NDA	Bayer HealthCare LLC.	0280-1200-02	2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)	2014-09-09
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352	NDA	Bayer HealthCare LLC.	0280-1200-03	160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)	2014-09-09

Suppliers for the Pharmaceutical Drug: ALEVE PM

Last updated: August 6, 2025

Introduction

ALEVE PM, a combination analgesic medication, offers multi-symptom relief for occasional sleeplessness and pain. With a formula combining naproxen sodium and diphenhydramine hydrochloride, ALEVE PM targets both inflammatory pain and temporary insomnia. As the demand for OTC sleep aids and pain relief products surges globally, understanding the supply chain dynamics and primary suppliers involved in ALEVE PM production becomes essential for stakeholders aiming to ensure consistent availability and quality.

Overview of ALEVE PM Composition and Manufacturing

ALEVE PM is produced by Bayer HealthCare LLC, a subsidiary of Bayer AG, headquartered in Germany. The product typically sources active pharmaceutical ingredients (APIs)—naproxen sodium and diphenhydramine hydrochloride—from various global suppliers. The manufacturing process involves multiple stages, including sourcing raw materials, API synthesis, formulation, and packaging. Each stage relies on a network of component suppliers that ensure raw material quality, compliance, and consistent supply.

Key Suppliers for ALEVE PM Active Pharmaceutical Ingredients

Naproxen Sodium Suppliers

Naproxen sodium, the non-steroidal anti-inflammatory drug (NSAID) component, is manufactured by leading chemical and pharmaceutical ingredient producers. Prominent suppliers include:

• Huntsman Corporation: A major supplier of naproxen and related NSAIDs, Huntsman produces pharmaceutical-grade naproxen sodium with stringent quality controls aligning with pharmacopeial standards. Huntsman’s global manufacturing facilities in Missouri and Belgium enable large-scale supply.

• Prasco Laboratories: Specializes in finished-dose formulations but also sources high-purity APIs, including naproxen sodium, from certified suppliers for their generic and OTC products.

• BASF SE: As a top chemical producer with a broad portfolio, BASF supplies pharmaceutical intermediates, including naproxen sodium, manufactured at their facilities in Europe and the US, adhering to cGMP standards.

• Mitsubishi Chemical: Produces pharmaceutical-grade APIs including naproxen sodium, primarily for the Asian market but also for global distribution.

Diphenhydramine Hydrochloride Suppliers

Diphenhydramine hydrochloride, an antihistamine with sedative properties, is sourced from the following key suppliers:

• Sun Pharmaceutical Industries Ltd.: A leading producer of diphenhydramine hydrochloride, with manufacturing plants in India and the US that meet regulatory standards (e.g., US FDA cGMP compliance).

• Teva Pharmaceutical Industries: A major generic drug manufacturer offering pharmaceutical-grade diphenhydramine hydrochloride sourced from their global manufacturing network, largely based in Israel and Europe.

• Alkem Laboratories: Supplies high-purity diphenhydramine hydrochloride and other antihistamines to international markets, following strict quality controls.

• LKT Laboratories: A US-based API manufacturer known for high-quality syntheses of antihistamines, including diphenhydramine hydrochloride.

Manufacturers and Contract Manufacturing Organizations (CMOs)

Beyond API suppliers, Bayer and other pharmaceutical contract manufacturers often rely on CMOs to produce finished dosage forms, including the tablet and capsule formulations of ALEVE PM. These CMOs often source APIs locally or globally, depending on regional regulations, cost efficiencies, and supply chain logistics.

Major contract manufacturing players involved in ALEVE PM production include:

• Recipharm: A global CMO providing formulation, encapsulation, and packaging services, often sourcing APIs from multiple suppliers.

• Catalent: Specializes in oral solid dosage formulation and packaging, working with multiple API suppliers to meet high-volume demand.

• Famar (Famar Group): Offers comprehensive manufacturing services, including quality assurance aligned with regulatory standards, for OTC products like ALEVE PM.

Supply Chain Dependencies and Risks

The supply of ALEVE PM hinges upon stable supply lines for both APIs. Disruptions in raw material sourcing—due to geopolitical issues, regulatory changes, or pandemic-related constraints—can impact production continuity.

• Geographical Concentration: Many APIs, especially diphenhydramine hydrochloride, are primarily produced in India and China, making supply vulnerable to regional policies and regulations.

• Regulatory Compliance: Suppliers must meet rigorous standards, including cGMP (current Good Manufacturing Practice) compliance, to ensure API purity and consistency. Any lapses can delay supply or impact product quality.

• Raw Material Availability: Fluctuations in raw material costs, supplier bottlenecks, or shortages of precursor chemicals may result in delays or increased costs.

Recent Trends Affecting Suppliers

• COVID-19 Disruptions: Pandemic-related disruptions affected the pharmaceutical supply chain globally, causing delays in API production and transportation.

• Regulatory Pressures: Stricter international standards and recalls have prompted suppliers to upgrade manufacturing processes, possibly impacting supply timelines.

• Market Demand Fluctuations: Growing demand for OTC sleep aids and NSAIDs has driven API manufacturers to ramp up production, leading to extensive supply agreements.

Competitive Landscape and Supplier Selection

Bayer’s selection of API suppliers for ALEVE PM reflects a focus on quality, reliability, and cost efficiency. Long-term contracts with established suppliers such as BASF, Huntsman, and Sun Pharmaceutics ensure steady supply, while maintaining flexibility with secondary suppliers mitigates risks.

In addition, the trend toward strategic supplier relationships and vertical integration enhances supply chain resilience, especially amid uncertain global conditions.

Conclusion

Understanding the supplier landscape for ALEVE PM highlights the complexity of sourcing high-quality APIs such as naproxen sodium and diphenhydramine hydrochloride. Strategic supplier partnerships, adherence to regulatory standards, and robust supply chain management are critical to ensuring consistent product availability. Players across the pharmaceutical supply chain must continuously adapt to geopolitical, regulatory, and market forces to sustain the production of this popular OTC medication.

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Key Takeaways

• Primary API Suppliers include Huntsman Corporation and BASF for naproxen sodium, and Sun Pharmaceutical Industries and Teva for diphenhydramine hydrochloride.

• Supply Chain Risks stem from regional manufacturing concentrations, geopolitical issues, and pandemic-related disruptions.

• Quality Compliance remains paramount; suppliers must meet cGMP standards to deliver consistent, pharmaceutical-grade APIs.

• Strategic Partnerships and Contracts underpin supply stability, with manufacturers often relying on multiple suppliers to mitigate risks.

• Global Market Dynamics influence API sourcing, with trends favoring increased production capacity and diversified supply sources to meet rising demand.

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Frequently Asked Questions

Q1: What are the main active ingredients in ALEVE PM, and why are they significant?
A1: ALEVE PM contains naproxen sodium, an NSAID providing pain relief, and diphenhydramine hydrochloride, an antihistamine with sedative effects. Their combination addresses both pain and sleeplessness effectively.

Q2: Who are the leading suppliers of naproxen sodium used in ALEVE PM?
A2: Major suppliers include Huntsman Corporation, BASF SE, Mitsubishi Chemical, and Prasco Laboratories, all of which produce pharmaceutical-grade naproxen sodium at scale.

Q3: How does the supply chain ensure the quality of APIs for ALEVE PM?
A3: Suppliers adhere to international regulatory standards such as cGMP, undergo rigorous quality control, and are subject to audits by Bayer and regulatory agencies (e.g., FDA, EMA).

Q4: What risks could disrupt the supply of ALEVE PM's active ingredients?
A4: Risks include geopolitical tensions, raw material shortages, pandemic-induced delays, regulatory changes, and quality compliance issues.

Q5: What trends are influencing API sourcing for OTC drugs like ALEVE PM?
A5: Increasing demand, global production capacity expansion, supply chain diversification, and stricter quality standards shape the sourcing strategies globally.

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Sources:

1. Bayer AG Official Website. (2022). Product information and manufacturing standards.
2. Huntsman Corporation. (2022). API production capabilities.
3. BASF SE. (2022). Pharmaceutical intermediates and APIs.
4. Sun Pharmaceutical Industries Ltd. Reports. (2022). API manufacturing and quality standards.
5. Regulatory agencies. (2022). cGMP compliance and API regulations.