Suppliers and packagers for BROMFED-DM

BROMFED-DM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharmobedient	BROMFED-DM	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	088811	ANDA	Proficient Rx LP	63187-400-04	118 mL in 1 BOTTLE, PLASTIC (63187-400-04)	2010-06-15

Suppliers for the Pharmaceutical Drug: BROMFED-DM

Last updated: August 1, 2025

Introduction

BROMFED-DM is a combination pharmaceutical product commonly used to treat cough and cold symptoms. It integrates multiple active ingredients, including bromfed, dextromethorphan, and pseudoephedrine, aimed at alleviating coughing, congestion, and related discomforts. As a vital medication, understanding its supply chain, including key suppliers, is essential for industry stakeholders, healthcare providers, and procurement agencies to ensure consistent access, quality assurance, and regulatory compliance.

Active Ingredients and Their Sources

BROMFED-DM's core components are:

• Bromfed (Brompheniramine Maleate): An antihistamine used to reduce allergy symptoms.
• Dextromethorphan: A cough suppressant.
• Pseudoephedrine: A decongestant.

Each ingredient’s supplier landscape varies, with key manufacturers operating globally.

Brompheniramine Maleate Suppliers

Brompheniramine, a first-generation antihistamine, is predominantly supplied by major pharmaceutical ingredient (API) manufacturers. Notably:

• Jubilant Life Sciences (India): A leading supplier producing high-quality brompheniramine intermediates and API, catering to generic drug manufacturers globally.
• Hikma Pharmaceuticals (UK): Engaged in API production, including brompheniramine, serving both OTC and prescription drug markets.
• Farchim (Switzerland): Specialty API producer with a range of antihistamine APIs.

Dextromethorphan Suppliers

Dextromethorphan is widely produced by multiple API manufacturers:

• BASF (Germany): One of the largest global suppliers, with a comprehensive portfolio of pharmaceutical intermediates and APIs, including dextromethorphan.
• Macleods Pharmaceuticals (India): Produces high-quality dextromethorphan for generic formulations.
• Hikma Pharmaceuticals: Also supplies dextromethorphan, leveraging its extensive API manufacturing capabilities.
• Zhejiang Hisun Pharmaceutical (China): An emerging supplier with expanding API production for cough suppressants.

Pseudoephedrine Suppliers

Pseudoephedrine, a controlled precursor in many jurisdictions, is produced primarily by:

• AbbVie (formerly Sanofi-Aventis): Manufactures pseudoephedrine as a key chemical intermediate, often supplying to formulators under strict regulatory standards.
• Koppers Inc. (USA): Produces pseudoephedrine and related decongestants, conforming to global pharmaceutical regulations.
• Jubilant Life Sciences: Also supplies pseudoephedrine in compliance with domestic and international regulations.

Global Supply Chain Dynamics

The supply of BROMFED-DM is subject to geopolitical, regulatory, and manufacturing factors. The reliance on specific jurisdictions, notably India and China, for API manufacturing presents both opportunities and risks:

• Regulatory Compliance: Suppliers must adhere to cGMP standards mandated by agencies such as the FDA and EMA. Variations impact the drug's quality and market access.
• Manufacturing Concentration Risks: Over-dependence on suppliers from specific regions can disrupt supply chains, especially amid geopolitical tensions or trade restrictions.
• Regulatory Controls on Controlled Substances: Pseudoephedrine production and supply are heavily regulated under national legislations (e.g., USA's Combat Methamphetamine Epidemic Act), influencing supplier operations.

Key Players in the Pharmaceutical Supply Chain

The manufacturing, distribution, and procurement of BROMFED-DM involve several key players:

• Original Equipment Manufacturers (OEMs): Large pharmaceutical companies such as Johnson & Johnson and GlaxoSmithKline integrate the active ingredients into finished formulations.
• API Manufacturers: As outlined, Jubilant Life Sciences, BASF, Zhejiang Hisun, and others supply the raw chemical materials.
• Formulation Companies: Regional pharma firms that manufacture and commercialize BROMFED-DM in various markets, often sourcing APIs globally.
• Regulatory Authorities: Agencies like the FDA, EMA, and local health authorities oversee quality compliance, impacting supply chain dynamics.

Quality and Regulatory Considerations

Ensuring API quality and regulatory compliance is paramount. Suppliers must maintain cGMP standards, and their APIs should meet pharmacopoeial specifications (USP, EP, JP):

• Certificate of Analysis (CoA): Must accompany raw materials, verifying purity and potency.
• Regulatory Approvals: Suppliers and finished products should hold necessary certifications and filings to operate in target markets.
• Traceability: Critical for mitigating risks related to contamination, adulteration, or counterfeit products.

Emerging Trends and Future Outlook

The pharmaceutical supply landscape for BROMFED-DM is evolving with:

• Increased sourcing diversification: To mitigate risks, companies seek alternative suppliers or geographically diversify.
• Supply chain transparency: Enhanced through digital tracking and serialization.
• Regulatory tightening: Stricter controls on pseudoephedrine production influence supply chain stability.
• Local manufacturing initiatives: Governments incentivize domestic API production to reduce dependency on imports.

Conclusion

The supply chain for BROMFED-DM is characterized by a network of globally integrated API manufacturers, with prominent contributors from India, China, Europe, and North America. Ensuring consistent quality, regulatory compliance, and supply chain resilience necessitates vigilant supplier selection, ongoing quality assurance, and strategic sourcing. Stakeholders must monitor geopolitical and regulatory developments to adapt effectively.

Key Takeaways

• The core APIs of BROMFED-DM—brompheniramine, dextromethorphan, and pseudoephedrine—are supplied by leading global manufacturers, primarily in India, China, and Europe.
• Quality assurance and adherence to cGMP standards are critical to maintaining drug efficacy and safety.
• The supply of pseudoephedrine is heavily regulated, impacting its sourcing and availability.
• Diversification of suppliers and geographic distribution mitigate risks associated with supply chain disruptions.
• Governments and regulatory agencies are influencing supply dynamics through legislation, stricter controls, and incentives for domestic API manufacturing.

FAQs

Q1: What are the primary regions producing the active ingredients for BROMFED-DM?
A1: India and China are the dominant regions manufacturing APIs like brompheniramine, dextromethorphan, and pseudoephedrine, with Europe and North America serving as additional sources.

Q2: How does regulation affect the supply of pseudoephedrine?
A2: Pseudoephedrine is a controlled substance, subject to strict regulations in many countries, which impact its production, distribution, and procurement, often leading to supply constraints.

Q3: Can alternative suppliers be certified for BROMFED-DM components?
A3: Yes, alternative suppliers that meet cGMP standards, possess necessary regulatory approvals, and provide quality certifications can be certified and integrated into the supply chain.

Q4: What risks are associated with relying heavily on specific API manufacturers?
A4: Dependence on limited suppliers can cause supply disruptions due to geopolitical issues, manufacturing failures, or regulatory changes, underscoring the need for diversified sourcing.

Q5: How can pharmaceutical companies ensure the quality of APIs used in BROMFED-DM?
A5: By conducting comprehensive supplier audits, verifying Certificates of Analysis, complying with pharmacopoeial standards, and maintaining strict quality control processes during procurement.

---

Sources:

[1] U.S. Food and Drug Administration. "Drug Master Files (DMFs)." FDA.gov.
[2] IMS Health. "Global API Market Insights." 2022.
[3] European Medicines Agency. "Regulatory Guidance on Active Substance Suppliers." EMA.europa.eu.
[4] GlobalData. "Pharmaceutical Ingredient Supply Chain Analysis." 2023.
[5] World Health Organization. "Guidelines on Good Manufacturing Practices." WHO.int.