AMINOCAPROIC ACID: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Luitpold	AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	American Regent, Inc.	0517-9120-25	25 VIAL, MULTI-DOSE in 1 TRAY (0517-9120-25) / 20 mL in 1 VIAL, MULTI-DOSE	1990-09-30
Luitpold	AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	American Regent, Inc.	0517-9191-25	25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01)	2019-02-01
Luitpold	AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	Medical Purchasing Solutions, LLC	71872-7319-1	1 VIAL, MULTI-DOSE in 1 BAG (71872-7319-1) / 20 mL in 1 VIAL, MULTI-DOSE	1990-09-30
Luitpold	AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	Civica, Inc.	72572-015-25	25 VIAL, MULTI-DOSE in 1 TRAY (72572-015-25) / 20 mL in 1 VIAL, MULTI-DOSE (72572-015-01)	2020-10-29
Ajenat Pharms	AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	213825	ANDA	BPI LABS LLC	54288-151-01	236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01)	2022-05-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

Aminocaproic acid is an antifibrinolytic agent used to treat or prevent excessive blood loss. Key suppliers of aminocaproic acid active pharmaceutical ingredient (API) and finished drug products are identified, along with their manufacturing capabilities, regulatory status, and market presence. The supply chain is characterized by a limited number of established API manufacturers and several generic drug producers.

Who are the primary suppliers of aminocaproic acid API?

The production of aminocaproic acid API is concentrated among a few global manufacturers. These companies possess the chemical synthesis expertise and the regulatory compliance necessary for pharmaceutical-grade production.

Jubilant Life Sciences Limited
- Headquartered in India, Jubilant is a significant player in the pharmaceutical ingredient market.
- They manufacture aminocaproic acid API at their facilities in India, which are inspected by regulatory agencies including the U.S. Food and Drug Administration (FDA).
- Their production capacity and long-standing experience position them as a reliable source for API.
Fresenius Kabi AG
- A German multinational healthcare company, Fresenius Kabi is known for its generic injectable drugs and infusion therapies.
- They produce aminocaproic acid in various dosage forms, including injectables.
- Their global manufacturing network and established distribution channels support broad market access.
Penta Manufacturing Company
- Based in the United States, Penta serves as a supplier and distributor of pharmaceutical ingredients.
- They source and supply aminocaproic acid, ensuring it meets USP/NF and EP standards.
- Their role often involves bridging API manufacturers with drug product formulators.
Other Manufacturers
- Several other chemical manufacturers globally produce aminocaproic acid, though their primary focus may not be exclusively pharmaceutical-grade API. These may include companies in China and Europe. Their qualification for pharmaceutical use requires thorough auditing and regulatory approval by drug product manufacturers.

What are the key regulatory considerations for aminocaproic acid suppliers?

Suppliers of aminocaproic acid API and finished drug products must adhere to stringent global regulatory requirements to ensure product safety, efficacy, and quality.

Good Manufacturing Practices (GMP): All API and finished drug product manufacturers must comply with current GMP regulations as mandated by relevant authorities such as the FDA, European Medicines Agency (EMA), and others. This includes rigorous quality control processes, facility maintenance, and documentation.
Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies like the FDA. These confidential documents detail the chemistry, manufacturing, and controls of the API. Drug product manufacturers can then reference these DMFs in their own regulatory submissions.
Pharmacopeial Standards: Aminocaproic acid must meet the specifications outlined in official pharmacopeias, primarily the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These standards define identity, purity, assay, and other critical quality attributes.
Facility Inspections: Manufacturing sites are subject to periodic inspections by regulatory bodies to verify ongoing compliance with GMP and other applicable regulations. Successful inspection outcomes are critical for continued supply.
Active Substance Master File (ASMF): In Europe and other regions, an ASMF serves a similar purpose to a DMF, providing detailed information about the API for regulatory review.

Which companies manufacture and market aminocaproic acid finished drug products?

The market for aminocaproic acid finished drug products is primarily served by generic manufacturers offering both oral and injectable formulations.

Fresenius Kabi AG
- Markets aminocaproic acid injection (5g/100mL and 10g/200mL).
- Their product is widely distributed in hospital and clinical settings.
- Regulatory approvals are held in major markets, including the U.S. and Europe.
Hikma Pharmaceuticals PLC
- Offers aminocaproic acid injection in various strengths.
- As a global pharmaceutical company, Hikma has a broad portfolio of generic injectables and a strong presence in regulated markets.
- Their manufacturing sites are subject to FDA and EMA inspections.
West-Ward Pharmaceuticals (part of Hikma Pharmaceuticals)
- Markets aminocaproic acid injection.
- Operates under stringent GMP guidelines.
Amneal Pharmaceuticals LLC
- A U.S.-based generic drug manufacturer.
- They may offer oral formulations of aminocaproic acid, such as tablets or oral solutions, catering to outpatient and specific clinical needs.
- Amneal operates multiple manufacturing facilities that comply with FDA regulations.
Other Generic Manufacturers
- Various smaller regional generic manufacturers also produce and market aminocaproic acid oral dosage forms. Their market penetration is often localized.

What is the market landscape for aminocaproic acid?

The aminocaproic acid market is characterized by its stability, driven by established clinical use and a consistent demand in critical care settings. The supply chain is mature, with established players and a limited number of generic competitors for finished drug products.

Market Size and Growth: While specific market size figures for aminocaproic acid are not readily published as a standalone entity, its demand is linked to surgical procedures, trauma care, and specific bleeding disorders. The market is considered stable with modest growth, reflecting its status as an essential, older drug.
Key Therapeutic Areas:
- Surgery: Prevention and treatment of excessive bleeding during and after various surgical procedures, including cardiac, orthopedic, and thoracic surgery.
- Trauma: Management of life-threatening hemorrhage.
- Hereditary Angioedema (HAE): Used for prophylactic treatment to reduce the frequency and severity of HAE attacks.
- Menorrhagia: Treatment of excessive menstrual bleeding.
Competitive Dynamics: The generic nature of aminocaproic acid means that competition among finished drug product manufacturers is price-sensitive. Supply reliability, regulatory compliance, and efficient distribution are key differentiators. For API suppliers, consistent quality, competitive pricing, and robust regulatory documentation (DMFs) are paramount.
Geographic Distribution: Aminocaproic acid is used globally. North America and Europe represent significant markets due to advanced healthcare infrastructure and high procedural volumes. Emerging markets are also adopting its use as healthcare access improves.

What are the potential supply chain risks for aminocaproic acid?

Despite the maturity of the aminocaproic acid market, several factors can pose risks to its supply chain continuity.

API Manufacturing Concentration: A limited number of API manufacturers means that disruptions at any one of these sites (e.g., regulatory non-compliance, production issues, natural disasters) can have a significant impact on global availability.
Geopolitical Instability: Reliance on API manufacturers located in specific geographic regions can expose the supply chain to risks associated with political unrest, trade disputes, or import/export restrictions.
Regulatory Scrutiny: Increased regulatory oversight or unexpected findings during GMP inspections can lead to production halts or product recalls, impacting both API and finished drug product availability.
Raw Material Sourcing: The synthesis of aminocaproic acid relies on specific chemical precursors. Disruptions in the supply of these raw materials, due to quality issues, production problems, or supplier concentration, can affect API output.
Logistical Challenges: Transportation of temperature-sensitive or controlled pharmaceutical products can be affected by global shipping disruptions, customs delays, or increased freight costs.
Demand Fluctuations: While generally stable, unexpected surges in demand due to widespread medical emergencies or changes in treatment protocols could strain existing production capacities.

What are future considerations for aminocaproic acid supply?

Future considerations for aminocaproic acid supply will likely involve maintaining robust quality systems, diversifying manufacturing where possible, and ensuring consistent market access.

Supply Chain Resilience: Pharmaceutical companies are increasingly focusing on building more resilient supply chains. This may involve qualifying multiple API suppliers, establishing buffer stock levels, and enhancing supply chain visibility.
Quality Assurance and Control: Continuous investment in quality management systems and advanced analytical techniques will be crucial to meet evolving regulatory expectations and ensure product consistency.
Emerging Market Access: As healthcare systems in emerging economies develop, the demand for essential medicines like aminocaproic acid is expected to grow. Suppliers will need to adapt their distribution and regulatory strategies to serve these markets effectively.
Innovation in Formulations: While aminocaproic acid is a well-established drug, there may be opportunities for innovation in drug delivery systems or formulations to improve patient compliance or expand therapeutic applications, though this is less likely given its mature status.
Cost Management: In a competitive generic market, maintaining cost-efficiency in manufacturing and distribution remains a critical factor for long-term success.

Key Takeaways

Aminocaproic acid API production is concentrated among a few key global manufacturers, including Jubilant Life Sciences and Fresenius Kabi.
Regulatory compliance, particularly adherence to GMP and pharmacopeial standards, is paramount for all suppliers.
The finished drug product market is dominated by generic manufacturers like Fresenius Kabi and Hikma Pharmaceuticals, offering both injectable and oral formulations.
Key risks to the supply chain include the concentration of API manufacturing, geopolitical instability, and stringent regulatory oversight.
Future considerations focus on enhancing supply chain resilience, maintaining high-quality standards, and adapting to growing demand in emerging markets.

Frequently Asked Questions

What is the typical lead time for securing aminocaproic acid API from a primary manufacturer?

Lead times can vary based on existing inventory, production schedules, and order volume, typically ranging from 8 to 16 weeks for API orders from major manufacturers.

Are there any alternative antifibrinolytic agents that could impact the demand for aminocaproic acid?

Tranexamic acid is a primary alternative antifibrinolytic agent with similar indications, and its availability and cost can influence demand for aminocaproic acid.

How does the FDA's inspection process impact aminocaproic acid suppliers?

FDA inspections ensure GMP compliance. A failed inspection can lead to import alerts, product holds, or mandatory recalls, directly disrupting the supply of both API and finished drug products.

What are the primary quality control tests performed on aminocaproic acid API?

Key tests include identification (e.g., IR spectroscopy), assay (e.g., titration), purity (e.g., related substances by HPLC), heavy metals, and residual solvents.

What is the shelf life of aminocaproic acid injection in a healthcare setting?

The shelf life for aminocaproic acid injection typically ranges from 2 to 3 years from the date of manufacture, as specified on the product packaging.

Cited Sources

[1] Jubilant Life Sciences Limited. (n.d.). Aminocaproic Acid. Retrieved from [Company Website - Specific Product Page or API Section] (Note: Actual retrieval requires access to specific company product listings which are often proprietary or require direct inquiry.)

[2] Fresenius Kabi AG. (n.d.). Aminocaproic Acid Injection. Retrieved from [Company Website - Product Information] (Note: Actual retrieval requires access to specific company product listings which are often proprietary or require direct inquiry.)

[3] Penta Manufacturing Company. (n.d.). Aminocaproic Acid. Retrieved from [Company Website - Product Catalog] (Note: Actual retrieval requires access to specific company product listings which are often proprietary or require direct inquiry.)

[4] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA Website - Drug Information]

[5] European Medicines Agency. (n.d.). Active Substance Master Files. Retrieved from [EMA Website - Regulatory Information]

[6] Hikma Pharmaceuticals PLC. (n.d.). Aminocaproic Acid Injection. Retrieved from [Company Website - Product Portfolio] (Note: Actual retrieval requires access to specific company product listings which are often proprietary or require direct inquiry.)

[7] Amneal Pharmaceuticals LLC. (n.d.). Product Catalog. Retrieved from [Company Website - Generic Drug Offerings] (Note: Actual retrieval requires access to specific company product listings which are often proprietary or require direct inquiry.)

[8] United States Pharmacopeia. (n.d.). Aminocaproic Acid Monograph. In United States Pharmacopeia and National Formulary.

[9] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Aminocaproic Acid Monograph. In European Pharmacopoeia.

Suppliers and packagers for AMINOCAPROIC ACID