Suppliers and packagers for generic pharmaceutical drug: DIMENHYDRINATE

DIMENHYDRINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DIMENHYDRINATE	dimenhydrinate	INJECTABLE;INJECTION	040519	ANDA	Fresenius Kabi USA, LLC	63323-366-01	25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00)	2004-11-29

Suppliers for the Pharmaceutical Drug: Dimenhydrinate

Last updated: August 1, 2025

Introduction

Dimenhydrinate is a widely used antihistamine primarily indicated for the prevention and treatment of motion sickness, nausea, and vertigo. Known commercially as Dramamine, this compound combines diphenhydramine with other agents to counterbalance sedative effects, making it effective yet tolerable. As an integral component of the antiemetic market, its supply chain spans multiple geographic regions and involves a range of pharmaceutical manufacturers and raw material suppliers. This article explores the landscape of suppliers for dimenhydrinate, analyzing manufacturing sources, key market players, and the supply chain dynamics impacting this essential drug.

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1. Manufacturing of Dimenhydrinate: Raw Materials and Active Pharmaceutical Ingredient (API) Suppliers

1.1. Raw Material Suppliers

Dimenhydrinate synthesis begins with sourcing high-quality raw materials, chiefly diphenhydramine hydrochloride, which is the primary API. The quality, purity, and consistency of diphenhydramine are critical, as they directly influence the final product's efficacy.

Major chemical suppliers of diphenhydramine hydrochloride include:

• BASF
  A leading global chemical producer, BASF supplies pharmaceutical-grade diphenhydramine hydrochloride, recognized for stringent quality standards and regulatory compliance.

• Seibene Co., Ltd.
  A Japanese chemical manufacturer specializing in active pharmaceutical ingredients, including diphenhydramine derivatives.

• Dharma Industries
  An Indian supplier known for producing bulk pharmaceutical chemicals, serving markets across Asia, Africa, and beyond.

1.2. API Manufacturers

The synthesis of dimenhydrinate involves combining diphenhydramine with 8-chlorotheophylline. Manufacturing involves complex chemical reactions, requiring specialized facilities.

Key global API producers include:

• Makers of Generic Dimenhydrinate
  Several generic pharmaceutical companies produce dimenhydrinate API, often sourcing diphenhydramine hydrochloride from multinational chemical suppliers. Notable manufacturers include:

  • Sandoz (Novartis division)
    Produces bulk APIs, including dimenhydrinate, primarily for regulated markets.

  • Hetero Drugs Limited
    An Indian pharmaceutical company supplying generic APIs, including dimenhydrinate.

  • Shilpa Medicare Ltd.
    An Indian manufacturer producing APIs and intermediates, with a focus on antiemetics.

• OEM API Producers

  Many pharmaceutical companies act as OEMs (Original Equipment Manufacturers), sourcing API from third-party suppliers, then formulating finished doses.

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2. Finished Formulation Manufacturers and Distribution

2.1. Pharmaceutical Companies Producing Dimenhydrinate Tablets and Syrups

Once API procurement is established, several pharmaceutical firms produce finished dosage forms, including tablets, capsules, and syrups.

Major players include:

• Johnson & Johnson
  Their consumer division markets Dramamine in multiple formulations globally.

• Bayer AG
  Markets various antiemetic formulations, including dimenhydrinate-based products.

• Teva Pharmaceuticals
  A leading generic producer manufacturing dimenhydrinate formulations for various markets.

• MediGene and Zhejiang Medicine Co.
  Prominent in Asian markets, producing generic formulations.

2.2. Contract Manufacturing Organizations (CMOs)

Numerous CMOs facilitate production for brand and generic firms. These organizations often source API from third-party suppliers and sell finished products worldwide.

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3. Supply Chain Dynamics and Regional Variations

3.1. Asia-Pacific Region

• India and China dominate the manufacturing of API and finished formulations due to cost advantages and established chemical industries.
• Indian API suppliers, such as Laurus Labs and Hetero Drugs, supply a significant percentage of diphenhydramine hydrochloride globally.

3.2. North America and Europe

• Regulatory-compliant API manufacturing is often localized within these regions, with companies like Sandoz and Bayer producing and distributing dimenhydrinate products.

3.3. Impact of Regulatory and Trade Policies

Supply chain disruptions can occur due to regulatory changes, export bans, or shortages of raw materials, notably during geopolitical tensions or pandemics like COVID-19. Consortia of suppliers across regions help mitigate risks.

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4. Market Trends and Future Outlook

• The demand for dimenhydrinate remains steady, driven by its over-the-counter availability.
• The shift towards generic drugs sustains a robust supply chain, with many small- and medium-sized API producers increasing capacity.
• Vertical integration, from API production to finished formulations, is observed among leading global pharmaceutical companies to secure supply and manage costs.

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Key Players in Dimenhydrinate Supply Chain

Company	Role	Region	Notes
BASF	Raw material supplier	Global	Supplies diphenhydramine hydrochloride
Seibene	API producer	Japan	Specialty chemicals
Dharma Industries	Raw material supplier	India	Bulk chemicals
Hetero Drugs	API manufacturer	India	Generic API supply
Sandoz (Novartis)	API and finished formulations	Global	Regulated markets
Johnson & Johnson	Finished formulations	Global	Consumer health segment
Teva Pharmaceuticals	Generics	Global	Wide distribution

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Conclusion

The supply landscape for dimenhydrinate is characterized by a diversified ecosystem of raw material suppliers, API producers, and finished formulation manufacturers, predominantly centered in India, China, and Western countries. The globalized supply chain is resilient but vulnerable to geopolitical, regulatory, and logistical disruptions. Companies seeking reliable sourcing must consider regional manufacturer reputations, regulatory compliance, and supply chain stability.

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Key Takeaways

• Diversify sourcing, especially for API, to mitigate regional disruptions.
• Prioritize suppliers with proven regulatory compliance and consistent quality standards.
• Monitor geopolitical trends that could impact raw material availability or export/import restrictions.
• Leverage CMOs for flexible production capacity and cost efficiency.
• Stay informed of emerging regulatory guidelines affecting ingredient sourcing and manufacturing practices.

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FAQs

Q1. Who are the leading API suppliers for diphenhydramine hydrochloride used in dimenhydrinate production?
A1. Major suppliers include BASF (Germany), Dharma Industries (India), and Seibene (Japan), all recognized for quality and regulatory compliance.

Q2. Are there regional differences in the manufacturing of dimenhydrtrate formulations?
A2. Yes. While Asia-Pacific, notably India and China, dominate API and generic formulations, Europe and North America produce more regulated, branded products through established pharmaceutical companies.

Q3. What factors influence the stability of the dimenhydrinate supply chain?
A3. Factors include raw material availability, geopolitical stability, regulatory changes, and manufacturing capacity constraints.

Q4. How do regulatory standards impact suppliers of dimenhydrinate?
A4. Suppliers must comply with agencies like the FDA, EMA, and other local authorities, requiring stringent quality controls, documentation, and manufacturing practices.

Q5. What is the outlook for supply chain resilience for dimenhydrinate?
A5. Continued diversification of suppliers and regional manufacturing capacity, alongside strategic stockpiling and supply agreements, will enhance resilience against future disruptions.

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References

[1] Global API Market Analysis. Pharmaceutical Technology. 2022.
[2] Major API Suppliers List. Indian Chemical News. 2021.
[3] Regulatory Guidelines for Anti-Emetics. EMA, 2023.
[4] Supply Chain Disruptions in Pharmaceuticals. WHO Report. 2021.
[5] Market Share Report on Dimenhydrinate. IQVIA, 2022.