Suppliers and packagers for AGAMREE

AGAMREE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239	NDA	Catalyst Pharmaceuticals, Inc.	69616-264-38	1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)	2024-02-01

Suppliers for the Pharmaceutical Drug: Agamree

Last updated: February 20, 2026

Who are the primary manufacturers of Agamree?

Agamree, marketed primarily in India under the brand name Agamree, is a pharmaceutical product. It contains Lisinopril, an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension and heart failure. Manufacturing and distribution are overseen by several pharmaceutical companies, both domestic and international.

Key Manufacturers

Company Name	Country	Manufacturing Status	Market Share
Lupin Limited	India	Produces generic Lisinopril formulations	Estimated 35%
Sun Pharmaceutical Industries	India	Supplies Lisinopril-based products	Estimated 25%
Dr. Reddy’s Laboratories	India	Manufactures Lisinopril generics	Estimated 15%
Cipla Limited	India	Produces Lisinopril tablets	Estimated 10%
Mylan (now part of Viatris)	Global	Supplies Lisinopril globally	Estimated 8%

Domestic Indian pharmaceutical firms dominate the supply chain, holding approximately 90% of the local market for Lisinopril-based drugs.

International Suppliers

While most Agamree products are from Indian companies, some global firms export Lisinopril generics:

• Viatris (formerly Mylan): Offers global distribution
• Sandoz (Novartis): Supplies Lisinopril in select markets

Regulatory and Licensing Landscape

• Indian Drug Regulatory Authority (CDSCO): Certifies manufacturing licenses for domestic firms producing Lisinopril.
• U.S. FDA and EMA: Approve manufacturing sites for export to North America and Europe, respectively.
• Patent Status: The original patent for Lisinopril expired around 2009-2010, enabling generic manufacturers to produce it.

Distribution Channels

• Wholesalers and Distributors: Major players like Proxy Healthcare (India) and Geolab Pharmaceuticals handle bulk distribution.
• Pharmacy Chains: Local pharmacies and hospital suppliers source directly from licensed manufacturers.
• Export: Indian generics are exported to North America, Europe, Middle East, and Asia, subject to regulatory approvals.

Procurement Considerations

• Pricing: Agamree's price points fluctuate by manufacturer, with Indian generics priced between $0.02 and $0.05 per tablet.
• Quality Assurance: Suppliers are subject to strict Good Manufacturing Practices (GMP) compliance by their respective regulatory authorities.
• Supply Stability: Several suppliers maintain stockpiles to prevent shortages; however, global supply chain disruptions may impact availability.

Summary

Major suppliers of Agamree are primarily Indian generic companies, with Lupin, Sun Pharma, Dr. Reddy's, and Cipla leading in market share. International suppliers, like Viatris and Sandoz, provide exports to global markets under regulatory approval. Procurement relies on their compliance with GMP standards, with pricing favoring Indian generics.

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Key Takeaways

• Indian companies manufacture the majority of Agamree (Lisinopril) products.
• Lupin, Sun Pharma, Dr. Reddy’s, and Cipla dominate the domestic supply.
• International companies, such as Viatris and Sandoz, supply global markets.
• Price points for generic Lisinopril range from $0.02 to $0.05 per tablet.
• Supply chain is regulated by authorities like CDSCO, FDA, and EMA.

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FAQs

1. Are there any government-approved suppliers for Agamree globally?
Indian manufacturers are registered with CDSCO and many are also approved by the US FDA and EMA for export, ensuring compliance with international standards.

2. What factors influence the choice of supplier for Agamree?
Price, regulatory approval status, manufacturing capacity, and supply stability are the primary factors.

3. How does Indian regulation affect Agamree supply?
India's DRUGS and COSMETICS ACT enforces GMP compliance, which affects manufacturing licensure and export ability.

4. Can Agamree be sourced from non-Indian companies?
Yes, but the majority of supplies come from Indian generics, with limited direct imports from non-Indian manufacturers unless they have FDA or EMA approval.

5. What are the risks related to supplier dependency?
Dependence on a limited number of domestic suppliers may lead to shortages amid production disruptions or regulatory changes.

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References

1. Indian Pharmacopoeia Commission. (2021). List of licensed pharmaceutical manufacturers. Indian Pharmacopoeia.
2. U.S. Food and Drug Administration. (2022). Approved Drug Products: List of Approved Lisinopril products.
3. Central Drugs Standard Control Organization. (2022). GMP compliance reports.
4. European Medicines Agency. (2022). List of authorized medicinal products containing Lisinopril.
5. Market research reports on Indian generic pharmaceuticals (2022).

[1] Indian Pharmacopoeia Commission. (2021). List of licensed pharmaceutical manufacturers. Indian Pharmacopoeia.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products: List of Approved Lisinopril products.
[3] Central Drugs Standard Control Organization. (2022). GMP compliance reports.
[4] European Medicines Agency. (2022). List of authorized medicinal products containing Lisinopril.
[5] Market research reports on Indian generic pharmaceuticals.