Share This Page
Suppliers and packagers for AMINOCAPROIC ACID IN PLASTIC CONTAINER
✉ Email this page to a colleague
AMINOCAPROIC ACID IN PLASTIC CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | AMINOCAPROIC ACID IN PLASTIC CONTAINER | aminocaproic acid | INJECTABLE;INJECTION | 070010 | ANDA | Henry Schein, Inc. | 0404-9812-20 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9812-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2021-10-26 |
| Hospira | AMINOCAPROIC ACID IN PLASTIC CONTAINER | aminocaproic acid | INJECTABLE;INJECTION | 070010 | ANDA | Hospira, Inc. | 0409-4346-73 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16) | 2010-05-12 |
| Hospira | AMINOCAPROIC ACID IN PLASTIC CONTAINER | aminocaproic acid | INJECTABLE;INJECTION | 070010 | ANDA | Medical Purchasing Solutions, LLC | 71872-7359-1 | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7359-1) / 20 mL in 1 VIAL, SINGLE-DOSE | 2010-05-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Aminocaproic Acid in Plastic Containers
Introduction
Aminocaproic acid, an antifibrinolytic agent used primarily to control bleeding in surgical and traumatic settings, commands a significant position in pharmaceutical markets worldwide. Its administration often involves plastic containers, which offer advantages in terms of sterility, ease of use, and logistics. This article explores leading suppliers adept at manufacturing and distributing aminocaproic acid in plastic containers, providing key insights for pharmaceutical companies, healthcare providers, and investors seeking reliable sourcing options.
Market Overview of Aminocaproic Acid
Aminocaproic acid, also known as epsilon-aminocaproic acid, acts by inhibiting plasminogen activation, thereby preventing fibrinolysis. Traditionally supplied in various formats—vials, ampoules, and bags—plastic containers are increasingly favored due to their durability, compatibility, and safety profile. The global demand for aminocaproic acid spans hospitals, clinics, and surgical centers, especially in regions with advanced healthcare infrastructure.
Major Suppliers and Manufacturers
1. Pfizer Inc.
Overview: Pfizer remains a leading global player in developing and distributing aminocaproic acid formulations. Its manufacturing facilities produce high-quality drugs in sterile plastic containers, often in the form of injectable solutions. An established distribution network ensures accessibility across multiple regions.
Product Range and Market Reach: Pfizer offers aminocaproic acid in plastic syringes and infusion bags, compliant with strict Good Manufacturing Practices (GMP). The company’s emphasis on quality and regulatory compliance makes it a preferred supplier for hospitals and healthcare providers worldwide.
Strategic Advantages: Pfizer’s robust global supply chain, extensive R&D capabilities, and adherence to international standards ensure a reliable supply of aminocaproic acid in plastic formats.
2. Teva Pharmaceutical Industries Ltd.
Overview: An Israel-based multinational, Teva specializes in generics, including antifibrinolytic agents like aminocaproic acid. Its manufacturing divisions cater extensively to global markets, producing in sterile plastic containers suitable for clinical use.
Product Portfolio: Teva supplies aminocaproic acid primarily in injectable forms within plastic vials and bags, designed for hospital settings. Its focus on affordability combined with compliance to quality standards positions Teva as a key supplier in emerging markets.
Supply Capabilities: With a widespread distribution network and emphasis on biosafety, Teva’s aminocaproic acid products are widely trusted for consistency and regulatory adherence.
3. Sagent Pharmaceuticals (Part of Moderna)
Overview: Sagent Pharmaceuticals specializes in sterile injectable pharmaceuticals, including aminocaproic acid. Recently acquired by Moderna, it expanded its portfolio to serve a broader global market.
Formulations: The company emphasizes pre-filled syringes and infusion bags made from high-grade plastics, ensuring stability and sterility during transportation and storage.
Operational Strengths: Sagent’s focus on innovative packaging, including ready-to-use plastic containers, enhances safety and convenience for end-users. Its adherence to strict regulatory standards enhances supply reliability.
4. LSK BioAnalysis / SAGE Labs
Overview: Based in South Korea, LSK BioAnalysis, and associated labs like SAGE, manufacture aminocaproic acid for export, including formulations in plastic vials and bags. They cater predominantly to Asian markets but are increasing their penetration into Europe and North America.
Product Specifications: Their aminocaproic acid solutions are packaged in medical-grade plastics, meeting international sterility and compatibility standards.
Competitive Edge: Competitive pricing and reliable supply chains make them an attractive option, especially for markets seeking cost-effective solutions.
5. Local and Regional Manufacturers
In addition to global giants, several regional manufacturers supply aminocaproic acid in plastic containers. These include companies within China, India, and Eastern Europe that produce generic formulations aligned with local regulatory norms. For example:
- Sun Pharmaceutical Industries Ltd. (India)
- Hunan Yuhua Pharmaceutical Co., Ltd. (China)
- KRKA, d.d., Novo Mesto (Slovenia)
These manufacturers often offer competitively priced products in plastic bottles and syringes, meeting domestic and some international standards.
Regulatory and Certification Considerations
Suppliers must hold certifications such as GMP, ISO 13485 for medical devices, and US FDA approval or EMA compliance for export markets. This ensures their aminocaproic acid products in plastic containers are fit for clinical use and meet quality control standards. Buyers should verify regulatory documentation, stability data, and batch testing protocols before procurement.
Emerging Trends and Opportunities
- Pre-Filled Plastic Containers: Increasing demand for pre-filled syringes or infusion bags reduces preparation time and contamination risks. Suppliers investing in advanced plastic-formulation technologies are gaining a competitive edge.
- Regional Manufacturing Hubs: Countries like India and China focus on large-scale manufacturing with cost advantages, positioning themselves as critical suppliers in the global supply chain.
- Supply Chain Resilience: COVID-19 underscored the importance of diverse sourcing strategies; suppliers with multiple manufacturing sites and robust logistics are preferred partners.
Conclusion
Global sourcing of aminocaproic acid in plastic containers involves a mix of multinational corporations, regional players, and generic manufacturers. Pfizer and Teva currently lead in innovation, regulatory compliance, and distribution capabilities. Emerging regional manufacturers provide cost-effective options but require careful validation regarding quality assurance. Strategic procurement should consider supplier reliability, compliance standards, and flexibility to adapt to market demands.
Key Takeaways
- Leading global suppliers of aminocaproic acid in plastic containers include Pfizer, Teva, and Sagent Pharmaceuticals, with extensive distribution networks and adherence to international standards.
- Regional manufacturers from China, India, and Eastern Europe offer cost-effective alternatives but necessitate thorough quality validation.
- Pre-filled plastic syringes and infusion bags are increasingly preferred formats due to safety and convenience benefits.
- Compliance with GMP, ISO, and other regulatory certifications is critical to ensure product quality and patient safety.
- Diversifying supply sources and prioritizing suppliers with resilient logistics enhances procurement security amid global disruptions.
FAQs
1. What are the primary formats of aminocaproic acid supplied in plastic containers?
Aminocaproic acid is predominantly supplied as injectable solutions in vials, pre-filled syringes, and infusion bags made of high-grade plastics designed for sterile medical applications.
2. How can buyers verify the quality of aminocaproic acid in plastic containers from regional manufacturers?
Buyers should request certification documents, including GMP compliance certificates, stability testing data, and third-party quality assessment reports. Performing audits or audits via certified third-party inspectors can further validate quality.
3. Are there specific regulatory considerations when sourcing aminocaproic acid in plastic formats?
Yes. Suppliers must demonstrate compliance with regional regulations such as the US FDA, EMA, or PMDA. Product documentation should include registration certificates, expiration data, and stability studies aligned with the intended market's standards.
4. Which suppliers are best suited for urgent or high-volume procurement?
Pfizer, Teva, and Sagent have extensive manufacturing capacities and global distribution networks capable of fulfilling high-volume orders promptly. Regional manufacturers may offer faster turnaround times for local markets.
5. What emerging trends should buyers monitor in this segment?
Key trends include the development of pre-filled plastic syringes, regional manufacturing expansion, and adoption of digital supply chain management tools to enhance transparency and resilience.
References
[1] U.S. Food and Drug Administration (FDA). Drug Approvals and Regulatory Information.
[2] Pfizer Inc. Product Catalog and Regulatory Compliance Data.
[3] Teva Pharmaceuticals Annual Report 2022.
[4] Sagent Pharmaceuticals Corporate Overview.
[5] LSK BioAnalysis and SAGE Labs Product Data Sheets.
More… ↓
