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Suppliers and packagers for generic pharmaceutical drug: PENCICLOVIR
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PENCICLOVIR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-0896-55 | 1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBE | 2022-11-16 |
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629 | NDA | Mylan Pharmaceuticals Inc. | 0378-9720-55 | 1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE | 2018-09-24 |
| Amneal | PENCICLOVIR | penciclovir | CREAM;TOPICAL | 214100 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1791-7 | 1 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBE | 2025-08-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Penciclovir
Introduction
Penciclovir is an antiviral medication primarily used in the treatment of herpes simplex virus infections, including cold sores. Its efficacy in topical formulations has made it a significant asset within antiviral pharmacopeia. As demand for effective herpes treatments persists, the supply chain for penciclovir—comprising raw material manufacturers, active pharmaceutical ingredient (API) producers, and finished drug manufacturers—becomes critically important. This report provides an in-depth overview of key suppliers involved in the production and distribution of penciclovir globally, delineating their capabilities, geographic distribution, and strategic importance to the pharmaceutical industry.
Chemical Composition and Production Process
Penciclovir (C₁₃H₁₇N₅O₃) is a nucleoside analogue of guanosine, synthesized through complex organic chemistry processes. Its manufacturing involves multiple stages, including synthesis of intermediates, purification, and formulation. The supply chain begins with chemical raw material suppliers, progressing through API producers, and culminating with finished drug manufacturers.
Major Raw Material and Intermediary Suppliers
1. Chemical Raw Material Providers
The backbone of penciclovir production relies on high-purity chemicals such as guanine derivatives, amino acids, and specific solvents. Leading suppliers for these raw materials include:
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Thermo Fisher Scientific: Supplies custom synthesis chemicals and intermediates. Their global distribution network ensures availability for large-scale manufacturing.
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Sigma-Aldrich (Merck Group): Offers a plethora of raw chemicals, including nucleoside precursors and solvents crucial for penciclovir synthesis.
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Alfa Aesar (Thermo Fisher Scientific): Provides specialized chemicals and building blocks necessary for API manufacturing.
2. Intermediates Manufacturers
Manufacturers specializing in intermediates for nucleoside analogues are pivotal suppliers in penciclovir’s production chain:
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Carbogen Amcis: Based in Switzerland, they specialize in small molecule synthesis and phase-appropriate manufacturing for APIs, including nucleoside analogues.
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CordenPharma (CordenPharma International): Offers tailored API intermediates for antiviral drugs, including penciclovir intermediates, with high purity standards.
Active Pharmaceutical Ingredient (API) Suppliers
Penciclovir API is produced by several key pharmaceutical manufacturers, many of which operate in Asia, Europe, and North America:
1. Morningside Healthcare (China)
- Overview: One of the leading API producers in China, Morningside has capabilities for large-scale synthesis of antivirals, including penciclovir.
- Strengths: Cost-effective manufacturing, robust GMP compliance, extensive export network.
- Strategic Role: Supplies both for domestic brands and international markets, often serving generic drug manufacturers.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
- Overview: A major player in antiviral APIs, with advanced synthesis technology for nucleoside analogues.
- Strengths: Quality control, consistent supply, competitive pricing.
3. Hetero Labs Ltd. (India)
- Overview: Recognized for its broad portfolio in antiviral drugs, including penciclovir APIs.
- Strengths: Cost efficiency, scalable production, regulated manufacturing standards compliant with international guidelines.
4. Aurobindo Pharma (India)
- Overview: Known for globally supplied generic APIs, including antivirals.
- Strengths: Well-established manufacturing facilities, extensive export network.
5. Teva Pharmaceutical Industries (Israel)
- Overview: A key manufacturer of antivirals and nucleoside analogues.
- Strengths: High-quality manufacturing, strong R&D background, global footprint.
Finished Drug Manufacturers and Formulators
The final product—topical penciclovir cream or gel—comes from specialized pharmaceutical firms:
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GlaxoSmithKline (GSK)
Historically developed and marketed penciclovir-containing topicals like Denavir in the U.S. GSK remains a significant supplier of branded formulations.
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Regaine (Meda Pharmaceuticals)
Manufactures penciclovir-based topical treatments in select markets, leveraging their extensive distribution network.
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Generic Manufacturers in India and China
Several companies, including Cadila Healthcare, Sun Pharmaceutical Industries, and Hetero Labs, manufacture and distribute generic penciclovir formulations, often sourced directly from API producers.
Distribution and Supply Chain Considerations
The supply chain for penciclovir involves multiple tiers—raw materials, intermediates, API, formulation, and distribution. Countries like China and India dominate API production due to cost advantages and manufacturing scale, making them primary suppliers globally. European and North American companies tend to focus on formulation and final drug distribution, ensuring compliance with stringent regulatory standards.
Increasing global demand for antiviral medications, compounded by the COVID-19 pandemic’s impact on supply chain resilience, has underscored the importance of diversification among penciclovir suppliers. Strategic partnerships and capacity investments are ongoing to mitigate shortages and enhance supply chain robustness.
Regulatory and Quality Standards
Suppliers must adhere to international Good Manufacturing Practices (GMP) outlined by agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and WHO. Certification, comprehensive quality control, and regulatory compliance are prerequisites for market access; failures can lead to supply disruptions or regulatory setbacks.
Emerging Suppliers and Future Trends
With increased demand, new players in emerging markets are entering the penciclovir supply chain, leveraging advanced synthesis technologies and competitive pricing. Notable developments include:
- China’s expanding pharmaceutical manufacturing sector, with investments in nucleoside analogue synthesis.
- Contract manufacturing organizations (CMOs) offering dedicated production lines for antiviral APIs.
- Technological advancements such as green chemistry and continuous manufacturing, which aim to improve yields, reduce costs, and enhance supply stability.
Key Challenges in Penciclovir Supply
- Regulatory hurdles and quality control at manufacturing sites.
- Supply chain disruptions driven by geopolitical tensions, trade restrictions, or pandemic-related closures.
- Price fluctuations impacted by raw material costs and capacity constraints.
- Intellectual property considerations in certain jurisdictions, influencing market entry and competition.
Conclusion
The penciclovir supply chain underscores a complex interplay of raw materials, API production, formulation, and global distribution—dominated by players in China, India, and select Western markets. As antiviral demand escalates, especially in the realm of topical herpes therapy, securing reliable suppliers and fostering strategic partnerships will remain critical for pharmaceutical companies. Emphasizing regulatory compliance, quality assurance, and supply chain resilience will determine continued access to this vital antiviral agent.
Key Takeaways
- The primary suppliers of penciclovir raw materials are chemical suppliers like Thermo Fisher and Sigma-Aldrich.
- Leading API manufacturers include Morningside Healthcare, Zhejiang Hisun Pharmaceutical, Hetero Labs, Aurobindo Pharma, and Teva.
- Most finished penciclovir formulations are produced by global pharmaceutical giants or regional generics manufacturers.
- Concentration of API manufacturing in China and India underscores cost advantages but necessitates robust quality controls to avoid supply disruptions.
- Strategic diversification and technological innovation are crucial for maintaining a resilient and compliant penciclovir supply chain.
Frequently Asked Questions (FAQs)
1. Who are the top global suppliers of penciclovir API?
Leading API producers include Morningside Healthcare (China), Zhejiang Hisun Pharmaceutical (China), Hetero Labs (India), Aurobindo Pharma (India), and Teva (Israel), all recognized for their manufacturing capacity and regulatory compliance.
2. What are the main raw materials used in penciclovir synthesis?
Key raw materials include nucleoside precursors like guanine derivatives, amino acids, and solvents, supplied by companies such as Thermo Fisher Scientific and Sigma-Aldrich.
3. Are there regional differences in penciclovir manufacturing?
Yes, Asian countries—particularly China and India—dominate API production due to cost efficiencies, while European and North American firms focus on formulation and final drug distribution.
4. How do regulatory standards impact penciclovir supply?
Suppliers must adhere to GMP and other regulatory standards (FDA, EMA). Failure to maintain compliance can lead to delays, recalls, or loss of market access.
5. What future trends could affect the penciclovir supply chain?
Emerging trends include increased capacity from emerging markets, technological advancements in manufacturing, and supply chain diversification strategies to mitigate disruptions.
Sources:
- [1] Pharmaceutical Technology. "Global API Market Insights," 2022.
- [2] WHO, "Guidelines on Good Manufacturing Practices," 2021.
- [3] IMS Health Reports, "Antiviral Market Trends," 2022.
- [4] Company websites and corporate disclosures of Morningside, Hetero, Zhejiang Hisun, Teva, and Aurobindo.
- [5] U.S. FDA Drug Approval and Manufacturing Data, 2022.
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