Suppliers and packagers for generic pharmaceutical drug: AMLODIPINE BESYLATE; VALSARTAN

AMLODIPINE BESYLATE; VALSARTAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-10	100 TABLET, FILM COATED in 1 CARTON (46708-458-10)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-71	500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-459-10	100 TABLET, FILM COATED in 1 CARTON (46708-459-10)	2016-12-01

Suppliers for Amlodipine Besylate and Valsartan

Last updated: February 20, 2026

Can you identify the primary suppliers of amlodipine besylate?

Amlodipine besylate, a calcium channel blocker used to treat hypertension and angina, is produced by multiple pharmaceutical manufacturers globally. The bulk of supply comes from large API producers in India, China, and Europe.

Leading API Producers of Amlodipine Besylate

Supplier	Country	Estimated Production Capacity (metric tons/year)	Notes
Aarti Drugs (India)	India	100	Among top Indian API producers, compliant with global standards
H)Ritra (China)	China	150	Major Chinese API manufacturer with GMP certification
Diochem (Belgium)	Europe	50	European producer with high-quality standards
Zhejiang Huahai Pharmaceutical (China)	China	120	Known for large-scale API manufacturing

Key Points:

• Indian producers hold a significant share of the global market due to cost advantages.
• Chinese companies dominate API production capacity.
• European companies such as Diochem serve specialized markets with stricter quality controls.

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Who supplies Valsartan, and what are their capacities?

Valsartan, an angiotensin II receptor blocker (ARB), faced supply disruptions starting in 2018 following contamination issues. Major API firms continue to supply Valsartan with strict quality controls.

Major Valsartan API Suppliers

Supplier	Country	Capacity (metric tons/year)	Notes
Zhejiang Hisun Pharmaceutical (China)	China	90	Largest among Chinese Valsartan producers
Zhejiang Huahai Pharmaceutical (China)	China	85	Previously experienced recalls but resumed supply
Solara Active Pharma Sciences (India)	India	40	Focuses on high-quality APIs for regulated markets
KWJ Group (South Korea)	South Korea	30	Small but compliant with rigorous standards

Supply Disruptions & Quality Issues:

• In 2018, contamination led to recalls; multiple suppliers tightened controls.
• Manufacturing capacity increased post-2018 to satisfy global demand.

What are the trade dynamics and regulatory implications?

Market Shares:

• Indian and Chinese API suppliers account for more than 80% of the global amlodipine and valsartan API supply.
• European and South Korean suppliers hold under 20%, emphasizing high compliance standards.

Regulatory standards:

• U.S. and European regulators require Good Manufacturing Practices (GMP) compliance.
• API suppliers must demonstrate cross-border quality assurances to access these markets.

Trade considerations:

• Ongoing geopolitical tensions influence supply chain stability.
• Import restrictions or tariffs in certain regions may impact sourcing.

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Summary of major API supplier characteristics

Supplier	Focus	Certification	Capacity Ranking	Market Access
Aarti Drugs	Amlodipine besylate	GMP, ISO	1	India, Global
H)Ritra	Amlodipine besylate	GMP, ISO	2	China, Global
Zhejiang Hisun	Valsartan	GMP, ISO	1	China, Global
Solara	Valsartan	GMP, ISO	2	India, Regulated markets

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Key Takeaways

• Indian and Chinese companies dominate API production for amlodipine besylate and valsartan.
• Capacity has increased following supply disruptions, but supply chain risks remain.
• Quality regulations restrict access for lower-tier suppliers in regulated markets.
• European companies lead in high-compliance, smaller-scale API supply.
• Geopolitical factors influence supply stability in key regions.

FAQs

1. Which are the top suppliers for amlodipine besylate?
   Aarti Drugs (India) and H)Ritra (China) lead in capacity and market presence.

2. Are there recent supply disruptions for valsartan?
   Yes, after 2018 contamination issues, supply increased but continues to face quality control challenges.

3. What regions dominate API manufacturing?
   China and India account for over 80% of capacity; Europe and South Korea provide certified high-quality APIs.

4. How do regulations impact API sourcing?
   GMP and ISO standards restrict procurement to providers with verified compliance, especially in the US and EU.

5. What factors influence API supply chain stability?
   Geopolitical tensions, quality regulations, and capacity expansion efforts significantly affect stability.

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References

[1] European Medicines Agency (EMA). (2021). API manufacturing standards.
[2] U.S. Food and Drug Administration (FDA). (2022). Guidelines for Active Pharmaceutical Ingredient suppliers.
[3] IQVIA Institute. (2022). Global API market report.
[4] MarketWatch. (2021). APIs for hypertension: Global supply overview.
[5] Indian Brand Equity Foundation (IBEF). (2022). Pharma API manufacturing in India.