Suppliers and packagers for generic pharmaceutical drug: bupropion hydrochloride

bupropion hydrochloride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-443-10	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-10)	2018-11-08
Accord Hlthcare	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-443-15	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-15)	2018-11-08
Accord Hlthcare	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-443-16	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-16)	2018-11-08
Accord Hlthcare	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-444-10	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10)	2019-03-25
Accord Hlthcare	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-444-16	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16)	2019-03-25

Suppliers for Bupropion Hydrochloride

Last updated: February 19, 2026

Multiple pharmaceutical companies manufacture bupropion hydrochloride, a widely prescribed antidepressant and smoking cessation aid. The following outlines key suppliers, manufacturing guidelines, and market dynamics.

Major Manufacturers and Suppliers

Global and Regional Players

• Teva Pharmaceuticals: One of the largest generic drug producers globally. Holds multiple patents and manufacturing rights for bupropion hydrochloride.
• Mylan (now part of Viatris): Supplies branded and generic formulations, including immediate-release, sustained-release, and extended-release versions.
• Sandoz (Novartis): Produces generic bupropion HCl, with active pharmaceutical ingredient (API) supply.
• Aurobindo Pharma: Manufactures both API and finished dosages, with a global distribution network.
• Lupin Pharmaceuticals: Key supplier for multiple regions, especially in Asia and Europe.
• Sun Pharmaceutical Industries: Active in the API market, with production capacities in the United States and India.

API Suppliers

• Akral Pharma: Supplies bulk API, with manufacturing facilities aligned with Good Manufacturing Practice (GMP).
• Hetero Labs: Provides API for generic formulations, with supply agreements in North America, Europe, and Asia.
• Cipla: Supplies API and finished formulations to various markets.

Supply Chain and Market Dynamics

• API Market: Dominated by India and China, accounting for over 70% of global API production capacity (2019–2022). Many suppliers in these countries have established long-term contracts with pharmaceutical firms.
• Regulatory Requirements: Suppliers must adhere to GMP standards issued by agencies such as the US FDA, EMA, and WHO. This limits the pool of qualified API manufacturers.

Regulatory Considerations

• FDA Approval: US suppliers with approved Abbreviated New Drug Applications (ANDAs) are preferred in the US market.
• EMA Certification: European suppliers require compliance with EU GMP standards.
• Quality Assurance: Suppliers often undergo audits and inspections by regulatory agencies or third-party auditors.

Market Trends

• Increased demand for generic formulations due to patent expirations.
• Supply chain shifts towards regional API manufacturing to mitigate geopolitical and pandemic-related disruptions.
• Expansion of manufacturing capacity in India and China for cost competitiveness.

Key Suppliers Summary Table

Supplier	Primary Products	Regions Covered	Regulatory Certification	Capacity Status
Teva	Bupropion Immediate/Extended-release	Global (North America, Europe, Asia)	FDA, EMA, WHO GMP	High, established
Mylan (Viatris)	Bupropion IR/ER	North America, Europe	FDA, EMA	Large, global distribution
Sandoz	Generic bupropion HCl	US, Europe, Asia	FDA, EMA	Moderate, scalable
Aurobindo Pharma	API and finished formulations	India, US, Europe	GMP, FDA	Expanding
Lupin	API and formulations	Asia, US, Europe	WHO GMP, US FDA	High

Conclusion

Bupropion HCl is supplied by a mix of large multinational generics firms and regional API manufacturers. Leading suppliers maintain regulatory compliance and significant manufacturing capacities, with India and China representing the primary source regions for API production.

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Key Takeaways

• Major global suppliers include Teva, Viatris (Mylan), Sandoz, Aurobindo, Lupin, and Sun Pharma.
• API production is concentrated in India and China, with high regulatory standards governing quality.
• Supply chain resilience relies on establishing GMP compliance and capacity expansion.
• The market is influenced heavily by patent expirations and regional regulatory policies.

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FAQs

1. What are the primary regions supplying API for bupropion hydrochloride?

   • India and China dominate API production, accounting for over 70% of global capacity.

2. Which regulatory standards must suppliers meet for US markets?

   • Good Manufacturing Practice (GMP) and approval via the FDA's Abbreviated New Drug Application (ANDA).

3. Are there regional differences in bupropion hydrochloride suppliers?

   • Yes, while global firms supply the US and EU, regional suppliers in India and China primarily supply Asia and emerging markets.

4. How has patent expiration affected supplier competition?

   • Patent expirations have increased generic market entries, boosting competition among suppliers.

5. What are the main factors influencing supplier selection for pharmaceutical companies?

   • Regulatory compliance, manufacturing capacity, quality consistency, and supply chain reliability.

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References

1. U.S. Food and Drug Administration. (2022). Inactive Ingredient Database. https://www.fda.gov/cosmetics/cosmetic-products/ingredients-used-cosmetic-products
2. MarketWatch. (2023). Global API market to reach USD 552.4 billion by 2027. https://www.marketwatch.com
3. Indian Pharmacopoeia Commission. (2021). API manufacturing standards. https://www.ipc.gov.in/
4. European Medicines Agency. (2022). Good Manufacturing Practice. https://www.ema.europa.eu
5. WIPO. (2020). Patent statistics for pharmaceuticals. https://www.wipo.int