Bulk Pharmaceutical API Sources for HETACILLIN POTASSIUM

Bulk Pharmaceutical API Sources for HETACILLIN POTASSIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23677959
NovoSeek		23678597
AAA Chemistry		AR-1L1638
ABI Chem		AC1Q1U2K

Bulk Active Pharmaceutical Ingredient (API) Sources for: Hetacillin Potassium

Last updated: August 1, 2025

Introduction

Hetacillin potassium, a broad-spectrum penicillin derivative, functions as an antibiotic used predominantly to treat bacterial infections. As a semi-synthetic penicillin, its efficacy and safety profile rely heavily on the quality of its active pharmaceutical ingredient (API). Ensuring access to reliable bulk API sources is vital for pharmaceutical manufacturers, regulatory agencies, and healthcare providers aiming to maintain manufacturing continuity, comply with regulatory standards, and guarantee drug safety.

Overview of Hetacillin Potassium API

Hetacillin potassium is synthesized through fermentation processes involving penicillin-producing strains or by chemical modifications of penicillin nuclei. The API must meet stringent quality standards — including purity, potency, and stability — dictated by pharmacopeias such as USP, EP, or BP. Securing high-quality bulk API involves sourcing from approved manufacturers with validated processes, rigorous quality control, and compliance with GMP (Good Manufacturing Practice).

Global API Suppliers for Hetacillin Potassium

1. Major Manufacturers and Suppliers

a. Teva Pharmaceuticals

As a leading generic API producer, Teva manufactures a broad spectrum of antibiotics, including penicillin derivatives. Their facilities adhere to international GMP standards, ensuring consistent quality. Teva offers hetacillin potassium API for global distribution, primarily sourcing from its facilities in Israel and India. The company's integrated supply chain guarantees reliable delivery timelines and adherence to regulatory requirements.

b. Mylan (now part of Viatris)

Viatris maintains a robust portfolio of penicillin APIs, including hetacillin potassium. Their manufacturing plants in India and the United States uphold rigorous quality standards, validated through regular audits. Mylan’s global reach and strong regulatory track record make it a dependable source for bulk API supplies.

c. Zhaohui Pharmaceutical

Based in China, Zhaohui specializes in producing various antibiotics, including early-generation penicillin derivatives such as hetacillin potassium. Their API production complies with GMP and other international standards, and they supply to multinational pharmaceutical firms worldwide. Their competitive pricing and capacity make them an attractive option for large-volume procurement.

d. Chengdu Shengke Pharmaceutical Co., Ltd.

This Chinese API manufacturer emphasizes antibiotic APIs with GMP certification and adherent to international quality standards. Shengke offers hetacillin potassium API with comprehensive analytical documentation, suitable for generic pharmaceutical companies targeting emerging markets.

e. Aurobindo Pharma

An Indian pharmaceutical giant, Aurobindo offers a variety of antibiotic APIs, including penicillin derivatives. Their API manufacturing facilities in Hyderabad are GMP-certified, providing high-quality raw materials with proven bioequivalence and low impurity profiles.

2. Emerging and Regional Suppliers

Several Asian manufacturers, notably from India and China, continue expanding their API production capabilities. These facilities respond to regional demand, providing cost-competitive options. Examples include:

• Hetero Labs: Focused on antibiotics, with GMP-certified APIs approved for global markets.
• Shandong Fufeng Group: Specializes in fermentation-based APIs, including penicillin derivatives.
• Hunan Jushui Pharmaceutical Co., Ltd.: Emerging producer with increased capacity and quality assurances.

Regulatory Considerations and Certification

Securing APIs from established suppliers is essential for compliance with regulatory agencies like the FDA, EMA, and PMDA. Suppliers with current Good Manufacturing Practice (cGMP) certification, validated process documentation, and comprehensive analytical reports facilitate faster registration processes and minimize import/export delays. Suppliers should provide:

• Certificate of Analysis (CoA)
• Certificate of Good Manufacturing Practice (cGMP)
• Stability data
• Raw material traceability documentation

Supply Chain Challenges and Strategies

Supply chain disruptions, driven by global events (e.g., pandemics, geopolitics), can impact API availability. Diversification of sources and establishing long-term supplier agreements bolster supply security. Additionally, onsite quality audits and continuous communication with manufacturers decrease risks of quality deviations.

Emerging Trends in API Sourcing for Hetacillin Potassium

• Vertical Integration: Pharmaceutical companies are increasingly investing in or acquiring API manufacturing units to secure supply chains.
• Quality by Design (QbD): Emphasized during API development, ensures consistent quality and facilitates regulatory approval.
• Sustainable Manufacturing: Suppliers adopting eco-friendly processes are gaining favor due to regulatory and societal pressures.
• Digitalization: Use of data analytics and supply chain transparency improves traceability and efficiency.

Conclusion

The procurement of high-quality hetacillin potassium API involves selecting reputable suppliers with established GMP compliance and robust quality assurance systems. Globally, manufacturers such as Teva, Viatris (Mylan), Aurobindo, and Chinese API producers like Zhaohui and Shengke provide reliable sources. Regional suppliers in India and China respond to growing demand, often offering competitive prices. Ensuring regulatory compliance and supply chain resilience remain paramount for continuous manufacturing.

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Key Takeaways

• Reliable sourcing of hetacillin potassium API depends on choosing GMP-certified manufacturers with validated processes.
• Major global suppliers include Teva, Viatris, Aurobindo, and Chinese API producers like Zhaohui.
• Regional manufacturers in India and China provide cost-effective alternatives amid supply chain uncertainties.
• Emphasis on regulatory documentation, including CoA and cGMP certification, ensures smooth approval processes.
• Diversifying suppliers and maintaining strong supplier relationships mitigate risks associated with supply disruptions.

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FAQs

1. What are the primary regions supplying hetacillin potassium API?
Major suppliers operate mainly from North America, Europe, China, and India. China and India are prominent due to cost advantages and manufacturing capacity.

2. How do I verify the quality of a bulk API supplier?
Review their GMP certification, inspect batch records, request Certificates of Analysis, and perform supplier audits. Regulatory compliance and third-party certifications are crucial indicators.

3. Are there specific regulatory hurdles when importing hetacillin potassium API?
Yes. Importers must ensure suppliers comply with local and international regulations, provide necessary documentation, and adhere to stability and purity standards dictated by authorities like the FDA or EMA.

4. Is it feasible to develop in-house API manufacturing for hetacillin potassium?
While technically feasible, it is resource-intensive, requiring significant investment in R&D, GMP-compliant facilities, and rigorous regulatory approval—costly for most pharmaceutical companies.

5. What is the typical lead time for bulk API procurement?
Lead times vary between 8-20 weeks, depending on supplier location, regulatory clearance, and order volume. Advanced planning and long-term agreements improve supply stability.