amicar: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	AMICAR	aminocaproic acid	SOLUTION;ORAL	015230	NDA AUTHORIZED GENERIC	Hikma Pharmaceuticals USA Inc.	0054-1100-58	236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58)	2019-03-12
Hikma	AMICAR	aminocaproic acid	TABLET;ORAL	015197	NDA AUTHORIZED GENERIC	Hikma Pharmaceuticals USA Inc.	0054-1110-13	30 TABLET in 1 BOTTLE (0054-1110-13)	2019-03-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Amicar, the common trade name for aminocaproic acid, is an antifibrinolytic agent used to prevent excessive bleeding in various clinical settings such as surgery, trauma, and bleeding disorders. The global demand for Amicar has increased owing to its vital role in surgical hemostasis and trauma management. As a result, identifying reliable suppliers of aminocaproic acid and Amicar is crucial for healthcare providers, pharmaceutical companies, and distributors seeking to ensure drug availability, quality, and regulatory compliance.

This comprehensive analysis details the primary suppliers of Amicar, the manufacturing landscape, and the key considerations for procurement based on quality standards, geographic distribution, and regulatory approvals.

Global Supply Landscape for Amicar (Aminocaproic Acid)

The supply chain for Amicar predominantly comprises pharmaceutical manufacturers and active pharmaceutical ingredient (API) producers. Given its widespread medical utility, the market features both branded and generic suppliers.

Major Suppliers of Aminocaproic Acid API

1. Chinese Manufacturers

China is a pivotal contributor to the global aminocaproic acid supply, with numerous API producers offering both bulk API and finished dosage forms.

Shandong Xinhua Pharmaceutical Co., Ltd.
One of the largest Chinese API manufacturers, Xinhua Pharmaceutical supplies aminocaproic acid API globally. The company emphasizes quality compliance, FDA registration, and adherence to international Good Manufacturing Practices (GMP) [1].
Jiangxi Baicao Pharmaceutical Co., Ltd.
Recognized for producing high-quality APIs, Baicao supplies aminocaproic acid with certifications catering to both domestic and export markets [2].
Shenzhen Beimei Biotech Co., Ltd.
This company offers amino acid derivatives, including aminocaproic acid, targeting both bulk API markets and finished pharmaceuticals [3].

2. Indian Manufacturers

India hosts several API manufacturers specializing in hemostatic agents. Many produce aminocaproic acid due to the country’s robust pharmaceutical manufacturing infrastructure.

Siddharth Medicare Ltd.
Offers aminocaproic acid API, approved by regulatory agencies such as the Central Drugs Standard Control Organization (CDSCO) [4].
Aminocaproic Acid (Generic) Suppliers in India
Others include small to mid-scale manufacturers supplying aminocaproic acid API compliant with WHO GMP standards, serving both domestic and export markets [5].

3. European and U.S. Suppliers

While less prominent in API production, some companies in Europe and the U.S. license or distribute aminocaproic acid formulations.

Pfizer Inc.
Historically, Pfizer marketed Amicar as a branded product in the U.S. and Europe, but manufacturing of the API may be outsourced or discontinued depending on market shifts.
Roxane Laboratories (a subsidiary of Boehringer Ingelheim)
Supplies Amicar in finished dosage forms rather than API, sourcing APIs from global manufacturers.

Manufacturers of Finished Dosage Forms (Brand and Generic)

In addition to API suppliers, several pharmaceutical companies manufacture and market Amicar in various formulations, including:

Pfizer Inc.
Historically, Pfizer was the primary producer of the branded Amicar, with manufacturing primarily located in North America and Europe. The brand is now generic in many markets, with Pfizer focusing on distribution.
Viatris Inc. (formerly Mylan and Pfizer generics divisions)
Offers generic Amicar in multiple markets, often sourcing APIs from Asian manufacturers.
Sun Pharmaceutical Industries Ltd.
Produces generic aminocaproic acid formulations for the Indian and international markets.
GSK and Teva Pharmaceuticals
License or distribute aminocaproic acid products conforming to their regional approvals.

Quality and Regulatory Standards

Procurement of Amicar requires adherence to stringent quality standards. Suppliers must comply with:

GMP certification to ensure batch-to-batch consistency and safety.
FDA approval for API producers aiming for the US market.
EMA certification and compliance with European Pharmacopoeia standards.
WHO-GMP certification for supplying to emerging markets and international organizations.

Failure to meet quality standards can result in regulatory non-compliance, product recalls, and safety concerns.

Regional Focus and Distribution Dynamics

North America:
Dominated by Pfizer, with API imported from Asian suppliers or manufactured in-house; compliance with U.S. FDA standards is mandatory.
Europe:
Suppliers tend to be European or licensed Asian manufacturers, with strict adherence to EMA standards.
Asia:
The primary source for raw API, with Chinese and Indian manufacturers providing cost-effective options for bulk procurement.
Emerging Markets:
Often rely on Asian API producers and domestic pharmaceutical companies producing generic formulations.

Supply Chain Challenges

Regulatory compliance: Ensuring API or finished product quality to meet global standards.
Manufacturing capacity constraints: Sudden surges in demand, such as during the COVID-19 pandemic, have highlighted supply vulnerabilities.
Pricing dynamics: Competition among Asian manufacturers offers competitive pricing but necessitates due diligence on quality assurance.
Geopolitical factors: Tariffs, export restrictions, or trade tensions can impact supply continuity.

Key Considerations for Procuring Amicar Suppliers

Quality Certifications: Confirm GMP, FDA, EMA, or WHO-GMP certifications.
Regulatory Approvals: Ensure the supplier’s API or finished formulation complies with local regulatory standards.
Supply Reliability: Verify the manufacturer’s production capacity, history of supply reliability, and logistical capabilities.
Pricing and Contract Terms: Balance cost-effectiveness with quality assurance and delivery timelines.
Traceability: Ensure transparency in sourcing, manufacturing, and quality testing reports.

Conclusion

The global supply of Amicar hinges predominantly on Asian API manufacturers complemented by regional and global pharmaceutical companies producing finished formulations. Successful procurement depends heavily on rigorous supplier qualification, regulatory compliance, and logistical reliability. As demand resurges in surgical and trauma care, relationships with accredited, quality-focused suppliers will be vital for uninterrupted supply chains.

Key Takeaways

Asian manufacturers, particularly from China and India, dominate aminocaproic acid API production, offering cost-effective and reliable sources.
European and U.S. markets rely on licensed manufacturers and distributors, often sourcing from Asian APIs.
Ensuring regulatory compliance (GMP, FDA, EMA, WHO) is critical for procurement success.
Supply chain resilience requires diversification, transparent sourcing, and robust quality assurance.
Market trends suggest a growing emphasis on capacity expansion and quality optimization among suppliers.

FAQs

1. Who are the leading suppliers of aminocaproic acid API globally?
Chinese companies such as Shandong Xinhua Pharmaceutical and Indian manufacturers like Siddharth Medicare are leading suppliers, offering high-quality APIs compliant with international standards.

2. Can I source Amicar from FDA-approved manufacturers?
Yes. Suppliers with FDA approval or certification compliant with cGMP standards are preferable for ensuring safety and regulatory compliance, especially for U.S. markets.

3. Are generic Amicar products of comparable quality to branded versions?
When sourced from certified manufacturers adhering to international GMP standards, generic Amicar products demonstrate comparable efficacy and safety to branded formulations.

4. What are the main risks associated with sourcing Amicar from Asian suppliers?
Potential risks include regulatory non-compliance, quality variability, supply disruptions, and logistical delays. Rigorous qualification and quality audits mitigate these risks.

5. How has the COVID-19 pandemic impacted Amicar supply chains?
The pandemic highlighted vulnerabilities in global supply chains, especially for APIs produced in Asia. It underscored the need for diversified sourcing and reliable quality assurance practices.

References

[1] Shandong Xinhua Pharmaceutical Co., Ltd., Product certifications and export data, 2023.

[2] Jiangxi Baicao Pharmaceutical Co., Ltd., Supplier profile, 2023.

[3] Shenzhen Beimei Biotech Co., Ltd., API portfolio and GMP standards, 2023.

[4] Central Drugs Standard Control Organization (CDSCO), Approved API manufacturers, 2023.

[5] WHO Prequalified APIs List, 2022.

Suppliers and packagers for amicar

amicar

Suppliers for the Pharmaceutical Drug: AMICAR