Suppliers and packagers for generic pharmaceutical drug: PENICILLIN V POTASSIUM

PENICILLIN V POTASSIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva	PENICILLIN-VK	penicillin v potassium	FOR SOLUTION;ORAL	060456	ANDA	Teva Pharmaceuticals USA, Inc.	0093-4125-73	100 mL in 1 BOTTLE (0093-4125-73)	1990-09-30
Teva	PENICILLIN-VK	penicillin v potassium	FOR SOLUTION;ORAL	060456	ANDA	Teva Pharmaceuticals USA, Inc.	0093-4125-74	200 mL in 1 BOTTLE (0093-4125-74)	1990-09-30
Teva	PENICILLIN-VK	penicillin v potassium	FOR SOLUTION;ORAL	060456	ANDA	Teva Pharmaceuticals USA, Inc.	0093-4127-73	100 mL in 1 BOTTLE (0093-4127-73)	1990-09-30

Suppliers for the Pharmaceutical Drug: Penicillin V Potassium

Last updated: July 28, 2025

Introduction

Penicillin V potassium (phenoxymethylpenicillin) remains a cornerstone in antibiotic therapy, particularly for the treatment of mild to moderate bacterial infections. Its stability in oral formulations, broad-spectrum activity, and well-established safety profile underpin its sustained demand globally. Identifying reliable suppliers of Penicillin V potassium is crucial for pharmaceutical manufacturers, healthcare providers, and procurement professionals aiming to ensure drug availability, quality, and cost efficiency. This report offers a comprehensive overview of the leading suppliers, their market positioning, and strategic considerations for sourcing this essential antibiotic.

Global Overview of Penicillin V Potassium Suppliers

Major Pharmaceutical Manufacturers

The supply landscape of Penicillin V potassium is dominated by a relatively small cohort of multinational pharmaceutical companies and regional generics manufacturers. These organizations possess the manufacturing expertise, quality assurance systems, and regulatory approvals necessary to produce pharmaceutical-grade Penicillin V potassium.

• Pfizer Inc.
  As a pioneer in antibiotic development, Pfizer has historically been a key supplier of Penicillin V potassium formulations, particularly in regions where they maintain manufacturing plants. Their global distribution network ensures consistent access to quality-assured Penicillin V.

• Sandoz (a Novartis division)
  Known for its robust generics portfolio, Sandoz supplies Penicillin V potassium globally, especially in markets emphasizing affordable medication options. Their manufacturing facilities are compliant with Good Manufacturing Practices (GMP), ensuring high standards.

• Cipla Limited
  An Indian pharmaceutical giant, Cipla produces Penicillin V potassium extensively for both domestic and export markets. Their focus on generic antibiotics has positioned them as a major regional supplier, particularly in Asia and Africa.

• GSK (GlaxoSmithKline)
  While GSK’s focus has shifted away from some older antibiotics, they historically contributed to Penicillin V supply and continue to do so in specific markets through licensing agreements.

• Aventis (Sanofi)
  Sanofi produces Penicillin V formulations for certain markets and collaborates with regional manufacturers to extend reach.

Regional and Contract Manufacturers

In addition to these global giants, several regional pharmaceutical companies produce Penicillin V potassium, often under licensing agreements or as generic formulations. Notable among these are:

• Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. (China)
• Laboratorios LA FRANQUICIA (Colombia)
• APOTEX Inc. (Canada)
• FARMO S.r.l. (Italy)

These manufacturers fulfill demand in emerging markets, where cost sensitivity and comparable quality standards make them key suppliers.

Regulatory and Quality Considerations

Suppliers of Penicillin V potassium must meet rigorous regulatory standards, including approval from authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or World Health Organization (WHO) prequalification, depending on the target market.

• GMP Certification: Ensures manufacturing processes adhere to global quality standards.
• Stability and Bioavailability: Suppliers must provide evidence of drug stability, especially since Penicillin V potassium is sensitive to moisture and temperature.
• Traceability and Documentation: Suppliers are expected to supply Certificates of Analysis (CoA), Good Manufacturing Practice certifications, and batch release data.

Ensuring supplier compliance minimizes risks related to substandard quality or supply disruptions.

Supply Chain Dynamics and Strategic Sourcing

The supply chain for Penicillin V potassium is sensitive to factors like raw material availability, geopolitical stability, and regulatory shifts.

Raw Material Sourcing

Penicillin V potassium is derived through fermentation of Penicillium chrysogenum, with chemical synthesis steps involved in forming the potassium salt. Key raw materials include:

• Penicillin G precursors
• Potassium salts
• Fermentation substrates

Suppliers involved in raw material supply influence overall cost and product stability.

Manufacturing Capacity and Scalability

As antimicrobial resistance threats evolve, demand for Penicillin V potassium fluctuates. Suppliers with flexible manufacturing capacities and robust quality control are better positioned to meet surges.

Pricing and Contracting Strategies

Long-term contracts with established suppliers can secure supply stability and favorable pricing. Buyers should assess supply chain reliability, regulatory status, and quality assurances when negotiating.

Emerging Trends and Market Opportunities

• Generic proliferation: As patent protections expire, the proliferation of generic Penicillin V potassium offers opportunities for cost-effective procurement.
• Regional manufacturing growth: Increased manufacturing capacity in Asia and Eastern Europe enhances supply security and reduces costs.
• Quality assurance initiatives: WHO prequalification programs are fostering supplier credibility, especially in low-income countries.

Challenges and Risks

• Quality Variability: Market influx of unregulated or substandard producers poses risks to patient safety.
• Regulatory Compliance: Varying region-specific approval processes can complicate procurement strategies.
• Supply Disruptions: Raw material shortages, geopolitical tensions, or manufacturing disruptions can cause delays.

Conclusion

The suppliers for Penicillin V potassium encompass a mix of established multinational pharmaceutical companies and regional generic manufacturers. Ensuring access to high-quality, GMP-compliant suppliers is vital amid market dynamics, regulatory requirements, and global health needs. Strategic sourcing, thorough supplier evaluation, and ongoing regulatory due diligence are essential for maintaining a reliable supply chain.

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Key Takeaways

• Major global suppliers include Pfizer, Sandoz, Cipla, GSK, and Sanofi, with regional manufacturers expanding accessibility.
• Regulatory compliance (GMP approval and certifications) is a critical criterion for supplier selection.
• Market opportunities lie in the proliferation of generics and regional manufacturing, especially in low- and middle-income countries.
• Supply chain resilience depends on raw material availability, manufacturing capacity, and geopolitical stability.
• Due diligence on quality standards and assurance processes reduces risks associated with substandard products.

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Frequently Asked Questions

1. Who are the leading global suppliers of Penicillin V potassium?
Major international suppliers include Pfizer, Sandoz (Novartis), Cipla, GSK, and Sanofi, with regional manufacturers also playing significant roles in emerging markets.

2. What quality standards should suppliers of Penicillin V potassium meet?
Suppliers must comply with GMP, possess relevant certifications (e.g., EMA, FDA approval), and provide certifications of analysis and traceability to ensure product safety and efficacy.

3. How does regional manufacturing influence Penicillin V potassium supply?
Regional producers enhance local availability, reduce costs, and improve supply resilience, especially in regions where global manufacturers have limited presence.

4. What challenges are associated with sourcing Penicillin V potassium?
Potential challenges include raw material shortages, quality variability, regulatory compliance differences across markets, and supply chain disruptions.

5. How can healthcare organizations ensure the quality of Penicillin V potassium?
By choosing suppliers with proven GMP compliance, independent quality assurance verification, and adherence to international standards, organizations can secure high-quality procurement.

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References

1. World Health Organization. Prequalification of medicines. WHO; 2022.
2. U.S. Food and Drug Administration. Responsibilities of Pharmaceutical Manufacturers. FDA; 2021.
3. European Medicines Agency. GMP Guidelines. EMA; 2022.
4. MarketsandMarkets. Antibiotics Market by Product and Application. 2023.
5. GlobalData. Pharmaceutical Industry Reports. 2023.