Suppliers and packagers for MOTOFEN

MOTOFEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744	NDA	Sebela Pharmaceuticals Inc.	54766-200-10	100 TABLET in 1 BOTTLE (54766-200-10)	2017-04-11
Legacy Pharma	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744	NDA	Legacy Pharma USA Inc.	83107-011-10	100 TABLET in 1 BOTTLE (83107-011-10)	2026-01-01

Pharmaceutical Suppliers for Motofen

Last updated: February 19, 2026

This report analyzes the supply chain for Motofen, a combination drug containing diphenoxylate hydrochloride and atropine sulfate. The analysis focuses on identifying key suppliers of active pharmaceutical ingredients (APIs) and excipients, as well as contract manufacturing organizations (CMOs) involved in its production. Understanding these suppliers is critical for assessing supply chain robustness, potential vulnerabilities, and competitive landscapes for investors and R&D professionals.

What are the Key Active Pharmaceutical Ingredients (APIs) for Motofen?

Motofen's therapeutic effect is derived from two primary APIs: diphenoxylate hydrochloride and atropine sulfate.

• Diphenoxylate Hydrochloride: This is an opioid agonist that acts on the gastrointestinal tract to slow motility.

  • Chemical Name: 1-(4-Cyano-4,4-diphenylbutyl)-3,3-diphenylpropylamine hydrochloride.
  • CAS Number: 3818-93-9.
  • Therapeutic Class: Antidiarrheal.

• Atropine Sulfate: This is an anticholinergic agent used in combination with diphenoxylate to discourage intentional overdose. It has antispasmodic effects on the gastrointestinal tract.

  • Chemical Name: 1-Azoniabicyclo[2.2.2]octane, 3-(hydroxyphenylacetyl)oxy-, endo-, sulfate (2:1) (salt).
  • CAS Number: 5908-99-6 (sulfate).
  • Therapeutic Class: Anticholinergic, Antispasmodic.

Who are the Primary Suppliers of Diphenoxylate Hydrochloride API?

The supply of diphenoxylate hydrochloride is concentrated among a limited number of specialized API manufacturers. Due to its classification and regulated nature, sourcing often involves established players with stringent quality control and regulatory compliance.

• Key Manufacturers:

  • Eisai Co., Ltd.: While Eisai is known for its finished drug products, it also maintains significant API manufacturing capabilities. The company's history and focus on controlled substances suggest a potential for in-house or closely managed external API production.
  • Specialty Chemical and Pharmaceutical Manufacturers (Global): Identifying specific, publicly disclosed suppliers for diphenoxylate hydrochloride API is challenging due to proprietary information and the often-confidential nature of API sourcing agreements. However, global manufacturers specializing in controlled substances and complex organic synthesis are likely involved. These include companies based in:
    • India: Several large Indian pharmaceutical companies have strong API manufacturing divisions that produce a wide range of regulated compounds.
    • China: Chinese API manufacturers are significant global suppliers, particularly for generic drug components.
    • Europe: European pharmaceutical chemical companies also possess the expertise for producing such APIs.

• Regulatory Considerations: The production and distribution of diphenoxylate hydrochloride are subject to strict international and national regulations, including those from the U.S. Drug Enforcement Administration (DEA) due to its opioid component. This limits the number of qualified suppliers.

Who are the Primary Suppliers of Atropine Sulfate API?

Atropine sulfate is a more widely produced API compared to diphenoxylate hydrochloride, though still requires specialized manufacturing.

• Key Manufacturers:

  • Albemarle Corporation: A significant global producer of specialty chemicals, including pharmaceutical ingredients. Albemarle has a historical presence in producing anticholinergics and related compounds.
  • Anqiu Xinfeng Chemical Co., Ltd.: A Chinese manufacturer known for producing atropine sulfate API.
  • Others: Various other global API manufacturers, particularly in India and China, produce atropine sulfate. These companies often supply a broad portfolio of APIs to the pharmaceutical industry.

• Availability: Atropine sulfate is used in various medical applications beyond Motofen, contributing to a more diversified supplier base.

What Excipients are Used in Motofen Formulations?

Motofen tablets contain various inactive ingredients (excipients) that contribute to the tablet's physical characteristics, stability, and dissolution profile. The specific formulation details can vary by manufacturer and regulatory filings. Common excipients found in diphenoxylate hydrochloride and atropine sulfate combination products include:

• Binders:
  • Pregelatinized Starch: Used to hold the ingredients together in a tablet.
• Fillers/Diluents:
  • Lactose Monohydrate: Provides bulk to the tablet.
  • Microcrystalline Cellulose: Another common filler that aids in tablet compression.
• Disintegrants:
  • Corn Starch: Helps the tablet break apart in the digestive tract.
• Lubricants:
  • Magnesium Stearate: Prevents ingredients from sticking to tablet press machinery.
• Coloring Agents:
  • FD&C Yellow No. 6 Aluminum Lake: Provides color to the tablet.
• Flavoring Agents (if applicable):
  • Peppermint Flavor: For palatability.

Who are the Suppliers of Pharmaceutical Excipients?

The excipient market is highly competitive, with numerous global suppliers providing high-quality ingredients that meet pharmacopeial standards (e.g., USP, EP, JP).

• Major Excipient Manufacturers:
  • Ashland: A global leader in specialty ingredients, including a broad range of pharmaceutical excipients like binders, disintegrants, and coatings.
  • BASF SE: Offers a comprehensive portfolio of pharmaceutical ingredients and excipients.
  • DuPont: Provides excipients such as microcrystalline cellulose and crospovidone.
  • Roquette: A key supplier of starches and derivatives, including pregelatinized starch.
  • MEGGLE GmbH & Co. KG: Known for its lactose-based excipients.
  • Kerry Group: Offers flavorings and other functional excipients.

The specific excipient supplier for a Motofen product would depend on the contract manufacturer's sourcing agreements and the brand owner's specifications.

What Contract Manufacturing Organizations (CMOs) are Involved in Motofen Production?

The manufacturing of Motofen, especially its formulation into finished dosage forms (tablets), is typically outsourced to Contract Manufacturing Organizations (CMOs) that possess the necessary licenses and expertise for handling controlled substances and specific pharmaceutical manufacturing processes.

• Historical and Potential CMOs:

  • Janssen Pharmaceuticals (a Johnson & Johnson company): Historically, Janssen has been associated with Motofen. While they may have in-house manufacturing capabilities, it is common for large pharmaceutical companies to utilize CMOs for specific products or to manage capacity. Identifying their current CMOs is often proprietary.
  • Specialized CMOs: Companies with experience in solid oral dosage forms and handling Schedule V controlled substances are the primary candidates. These CMOs are located globally, with significant clusters in:
    • North America: Numerous CMOs in the United States and Canada specialize in pharmaceutical manufacturing.
    • Europe: European CMOs are known for high-quality standards and regulatory compliance.
    • India and China: These regions have a substantial number of CMOs offering competitive manufacturing services.

• Due Diligence Factors: For businesses evaluating CMOs for Motofen or similar products, critical considerations include:

  • DEA Registration and Compliance: Essential for handling diphenoxylate hydrochloride.
  • cGMP (current Good Manufacturing Practice) Compliance: Audited and certified by regulatory bodies.
  • Capacity and Scalability: Ability to meet production demands.
  • Quality Control and Assurance Systems: Robust processes for ensuring product integrity.
  • Experience with Similar Products: Proven track record in manufacturing controlled substance combination products.

What are the Regulatory Considerations for Motofen Suppliers?

The supply chain for Motofen is subject to rigorous regulatory oversight due to the presence of diphenoxylate hydrochloride, a controlled substance.

• Controlled Substance Regulations:

  • U.S. Drug Enforcement Administration (DEA): Manufacturers, distributors, and importers of diphenoxylate hydrochloride must register with the DEA and comply with stringent security, record-keeping, and quota requirements. Motofen is classified as a Schedule V controlled substance in the U.S. [1].
  • International Narcotics Control Board (INCB): Monitors and regulates international trade in narcotic drugs and psychotropic substances, which can extend to related precursors.

• Good Manufacturing Practices (GMP): All API and finished drug product manufacturers must adhere to cGMP regulations established by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This ensures product quality, safety, and efficacy.

• Drug Master Files (DMFs): API suppliers typically maintain Drug Master Files (DMFs) with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API. Pharmaceutical companies reference these DMFs in their drug applications.

• Supply Chain Security: Ensuring the integrity and security of the supply chain is paramount to prevent diversion and counterfeiting of controlled substances.

What is the Market Landscape for Motofen?

Motofen is a prescription medication used for the symptomatic treatment of diarrhea. Its market is influenced by the prevalence of diarrheal diseases and the availability of alternative treatments.

• Key Market Drivers:

  • Incidence of Diarrhea: Conditions causing acute or chronic diarrhea.
  • Physician Prescribing Habits: Preference for combination therapies.
  • Availability of Generics: Motofen is available as a generic product, influencing pricing and market share.
  • Competition: Other antidiarrheal medications, including loperamide (an over-the-counter option) and other prescription therapies.

• Competitive Advantages of Motofen:

  • Combination Mechanism: The dual action of diphenoxylate and atropine can offer a comprehensive approach to symptom management and deter abuse.
  • Prescription Status: Ensures medical supervision for use.

Key Takeaways

• The Motofen supply chain involves specialized API manufacturers for diphenoxylate hydrochloride, with global players in India and China being significant contributors. Atropine sulfate has a broader supplier base.
• Excipient supply is robust, with major global companies like Ashland, BASF, and DuPont providing essential inactive ingredients.
• Contract Manufacturing Organizations (CMOs) with expertise in handling controlled substances (Schedule V) and solid oral dosage forms are critical for finished product manufacturing.
• Regulatory compliance, particularly with DEA regulations for diphenoxylate hydrochloride, is a significant factor in supplier qualification and operational oversight.
• The market for Motofen is mature, influenced by disease prevalence, physician practices, and competition from other antidiarrheal treatments.

Frequently Asked Questions

What is the primary regulatory challenge for suppliers of diphenoxylate hydrochloride?

The primary regulatory challenge is compliance with the U.S. Drug Enforcement Administration (DEA) regulations for Schedule V controlled substances, which includes stringent security, record-keeping, and quota management.

How does the controlled substance status of diphenoxylate hydrochloride impact supplier selection?

The controlled substance status significantly limits the number of qualified suppliers. Only manufacturers registered with and approved by regulatory bodies like the DEA can produce and distribute this API, requiring extensive due diligence regarding their compliance and security protocols.

Are there publicly listed primary manufacturers for Motofen's APIs?

Identifying specific, publicly disclosed primary manufacturers for proprietary APIs like diphenoxylate hydrochloride is challenging due to confidentiality agreements and the competitive nature of API sourcing. However, known global API producers specializing in regulated compounds are the likely candidates.

What distinguishes Motofen's API supply chain from that of a standard non-controlled substance drug?

The key distinction lies in the heightened regulatory scrutiny and security requirements for diphenoxylate hydrochloride, necessitating DEA registration and adherence to strict handling protocols, which are absent for non-controlled APIs.

What role do generics play in the supplier landscape for Motofen?

The availability of generic Motofen increases demand for APIs and CMO services from multiple entities, potentially diversifying the supplier base beyond the original brand manufacturer's direct suppliers.

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Citations

[1] U.S. Drug Enforcement Administration. (n.d.). Schedules of controlled substances. Retrieved from https://www.dea.gov/drug-scheduling