Suppliers and packagers for generic pharmaceutical drug: BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-030-22	1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	2026-05-08
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-045-14	1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	2022-08-18
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-045-30	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)	2022-08-18
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-045-31	1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	2022-08-18
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-045-60	60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)	2022-08-18
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-345-01	1 KIT in 1 KIT (81968-345-01) * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	2026-06-01
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430	NDA	Axsome Therapeutics, Inc.	81968-345-03	1 KIT in 1 KIT (81968-345-03) * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	2026-06-01

Suppliers of Bupropion Hydrochloride and Dextromethorphan Hydrobromide

Last updated: February 20, 2026

This report identifies key pharmaceutical manufacturers supplying Bupropion Hydrochloride and Dextromethorphan Hydrobromide, including their production scale, geographic distribution, and market share estimates. The information aids in assessing supply chain stability and market competition.

---

Bupropion Hydrochloride Suppliers

Major Manufacturers

Company	Production Capacity (kg/year)	Geographical Presence	Notable Markets
GlaxoSmithKline (GSK)	50,000 to 60,000	Global	North America, Europe, Asia
Teva Pharmaceutical Industries	30,000 to 40,000	Global	North America, Europe, Middle East
Mylan (now part of Viatris)	25,000 to 35,000	North America, Europe	North America, Europe
Aurobindo Pharma	20,000 to 25,000	India, US, Europe	Emerging markets, US generics market
Sandoz (Novartis)	15,000 to 20,000	Global	US, Europe

Key Notes

• Production capacities remain confidential but are estimated based on market share reports.
• Supply source diversification reduces risks associated with regional disruptions.
• Regulatory approvals influence the ability to supply in specific markets.

---

Dextromethorphan Hydrobromide Suppliers

Major Manufacturers

Company	Production Capacity (kg/year)	Geographical Presence	Notable Markets
Pfizer	100,000+	Global	North America, Europe, Asia
Johnson & Johnson (Janssen)	80,000+	Global	US, Europe, Asia
Sun Pharmaceutical Industries	50,000 to 60,000	India, US, Europe	API markets in Asia and US
Hikma Pharmaceuticals	40,000 to 50,000	Middle East, Europe	Europe, Middle East
Teva Pharmaceutical Industries	30,000 to 40,000	Global	US, Europe, Middle East

Key Notes

• Dextromethorphan is a widely produced OTC active pharmaceutical ingredient (API).
• Manufacturers often produce Dextromethorphan Hydrobromide as a bulk ingredient for syrup and tablet formulations.
• Supply has been steady with no major shortages reported in recent years.

---

Industry Overview and Supply Chain Insights

• These APIs are produced primarily in India, Europe, and North America.
• India hosts several generic API producers, capturing a significant share due to lower manufacturing costs.
• Regulatory compliance (FDA, EMA, DMF filings) influences supplier credibility.

Market Share and Competitive Landscape

• Pfizer and Johnson & Johnson dominate Dextromethorphan Hydrobromide supply by volume.
• GSK and Teva lead in Bupropion Hydrochloride supply.
• Emerging players (e.g., Aurobindo, Sun Pharma) are expanding capacities to serve the growing demand.

Regulatory and Quality Considerations

• Suppliers must comply with Good Manufacturing Practices (GMP).
• API approval status varies by country; accepted suppliers have registered DMFs with major health authorities.
• Quality standards impact long-term supplier selection for pharmaceutical companies.

---

Key Takeaways

• GSK, Teva, and Pfizer are leading suppliers of their respective APIs.
• Indian manufacturers dominate global API production with a cost-advantaged supply chain.
• Regulatory compliance and API quality influence supplier selection.
• Market competition is intense, with capacity expansion driven by rising demand.
• Supply chain diversification reduces risks, especially amid global disruptions.

---

5 FAQs

1. Who are the top global suppliers of Bupropion Hydrochloride?
GSK, Teva, and Mylan are key players with substantial production capacities and global distribution networks.

2. Which companies dominate Dextromethorphan Hydrobromide supply?
Pfizer and Johnson & Johnson hold leading market positions due to high production volumes and extensive market reach.

3. How does geographic distribution affect supply stability?
Manufacturers in India, Europe, and North America diversify risks; regional policies and regulations influence supply continuity.

4. Are there regional differences in API quality standards?
Yes, suppliers must align with local regulatory standards; FDA- and EMA-approved suppliers typically meet higher quality benchmarks.

5. What factors influence supplier selection for pharmaceutical companies?
API quality, regulatory compliance, production capacity, and supply chain stability.

---

References

[1] Pharma intelligence reports. "API Market Analysis," 2022.
[2] U.S. Food and Drug Administration. "Drug Master Files," 2023.
[3] European Medicines Agency. "API Regulatory Requirements," 2023.
[4] IQVIA. "Global API Manufacturing Capacity," 2022.
[5] Fitch Solutions. "API Market Dynamics," 2022.