Suppliers and packagers for generic pharmaceutical drug: DONEPEZIL HYDROCHLORIDE

DONEPEZIL 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
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119-01	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-01)	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119-04	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-04)	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119-08	1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08)	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119-51	3 BLISTER PACK in 1 CARTON (42658-119-51) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-120-01	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-120-01)	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-120-04	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-120-04)	2025-01-01
Hisun Pharm Hangzhou	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-120-08	1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-120-08)	2025-01-01

Suppliers for Donepezil Hydrochloride

Last updated: February 19, 2026

Which companies produce and supply donepezil hydrochloride internationally?

Donepezil hydrochloride, marketed primarily under the brand name Aricept, is a cholinesterase inhibitor used to treat Alzheimer's disease. Multiple suppliers offer bulk active pharmaceutical ingredients (APIs), intermediate commodities, or finished dosage forms.

Major API Suppliers of Donepezil Hydrochloride

1. Jiangsu Hengrui Medicine Co., Ltd.

• Location: China
• Product: Fully compliant with international standards, including USP and EP
• Capacity: Estimated at hundreds of kilograms annually
• Certifications: GMP, ISO 9001

2. Zhejiang Xianju Pharmaceutical Co., Ltd.

• Location: China
• Product: USP-grade donepezil hydrochloride
• Certifications: GMP, ISO 9001

3. Shanghai Synthealth Pharmaceuticals

• Location: China
• Product: Generic APIs including donepezil hydrochloride
• Status: Active on the Asian market

4. Jinan Zhongwei Pharmaceutical Co., Ltd.

• Location: China
• Product: GMP-certified API production
• Capacity & Certification: Details undisclosed but compliant with international standards

5. Hubei Haodong Pharmaceutical Co., Ltd.

• Location: China
• Product: Donepezil hydrochloride for bulk supply
• Certifications: GMP

Additional Suppliers and Synthetic Intermediates

• Many Chinese API manufacturers produce donepezil hydrochloride for export.
• European and Indian suppliers also manufacture intermediates used in synthesis but less often the final API.

Finished Dosage Form Manufacturers

• Several pharmaceutical companies globally produce donepezil in finished dosage forms, either under proprietary or generic labels.
• Notable companies include Mylan (now part of Viatris), Teva, and Sandoz.

Global Distribution & Market

Region	Main Suppliers	Estimated Market Share	Regulatory Certifications
China	Jiangsu Hengrui, Zhejiang Xianju	70%	GMP, ISO 9001
India	Sun Pharma, Cadila Healthcare	20%	WHO-GMP, DGCI approval
Europe/US	Mylan, Teva, Sandoz	10%	FDA, EMA approvals

Regulatory and Quality Considerations

• Most API suppliers in China hold GMP certificates recognized by the Chinese authority (CFDA).
• Exported APIs targeting North American and European markets require compliance with US FDA or EMA regulations.
• Quality standards include USP, EP, or JP monographs.

Supply Chain and Sourcing Risks

• Chinese suppliers dominate the API market, introducing risks related to regulatory changes and trade policies.
• Indian and European sources provide alternatives but at different scales and certification standards.
• Lead times for API production range from 4 to 12 weeks, depending on order size and certification compliance.

Summary

Most donepezil hydrochloride APIs originate from China, with a smaller but significant presence in India and Europe. Certified suppliers adhere to international GMP standards, essential for export and pharmaceutical manufacturing.

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Key Takeaways

• China supplies approximately 70% of global donepezil hydrochloride APIs, with major manufacturers including Jiangsu Hengrui and Zhejiang Xianju.
• GMP certification and regulatory compliance are critical for international supply acceptance.
• Supply stability depends on geopolitical factors, trade agreements, and regulatory oversight.
• Many alternatives exist in India and Europe, offering diversified sourcing options.
• Finished dosage forms are produced by several multinational pharmaceutical companies, with leading providers including Mylan, Teva, and Sandoz.

FAQs

1. Are there non-Chinese suppliers of donepezil hydrochloride?
   Yes, suppliers in India and Europe produce APIs, but their market share is smaller, and regulatory recognition varies.

2. What certifications should suppliers have for international distribution?
   GMP certification recognized by local authorities (FDA, EMA, CFDA) is essential alongside compliance with USP or EP standards.

3. What is the typical lead time for API orders?
   Lead times range from 4 to 12 weeks based on supplier capacity, order size, and certification process.

4. Can I source completed pharmaceutical products instead of APIs?
   Yes, several multinational firms produce finished donepezil hydrochloride tablets, which are available globally.

5. How do I assess API quality from suppliers?
   Review certification records, batch testing reports, and perform third-party testing if necessary, ensuring compliance with regulatory standards.

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References

[1] Chinese Pharmacopoeia. (2020). "Donepezil Hydrochloride." 12th Edition.
[2] US Food and Drug Administration. (2022). "API GMP Inspections."
[3] European Medicines Agency. (2022). "Quality standards for Active Ingredients."
[4] MarketWatch. (2023). "Global Donepezil Hydrochloride Market Analysis."
[5] IQVIA. (2022). "Active Pharmaceutical Ingredient Market Reports."