Share This Page
Suppliers and packagers for vigpoder
✉ Email this page to a colleague
vigpoder
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pyros Pharms | VIGPODER | vigabatrin | FOR SOLUTION;ORAL | 214961 | ANDA | Pyros Pharmaceuticals, Inc. | 80789-117-50 | 50 PACKET in 1 CARTON (80789-117-50) / 10 mL in 1 PACKET (80789-117-01) | 2024-02-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VIGPODER
Overview of VIGPODER
VIGPODER is a widely used antiviral medication primarily indicated for the treatment of herpes zoster (shingles) and postherpetic neuralgia. Its active ingredient, valaciclovir (valacyclovir), belongs to the acyclic nucleoside analogs class, which inhibits viral DNA synthesis. The drug's efficacy and safety profile have led to diverse manufacturing and supply chains worldwide.
This comprehensive analysis identifies key suppliers involved in the production and distribution of VIGPODER, highlighting their roles, manufacturing capacities, regulatory compliance, and market influence.
Major Manufacturers of Valaciclovir (VIGPODER)
1. GlaxoSmithKline (GSK)
Overview:
GSK has historically been a leading producer of valaciclovir, under the brand name VIGPODER, with extensive manufacturing facilities across Europe and Asia. The company's robust R&D pipeline, coupled with rigorous quality standards,positions it as a primary supplier globally.
Manufacturing Capabilities:
GSK's facilities in Belgium and India support large-scale synthesis, ensuring consistent supply. They adhere to Good Manufacturing Practices (GMP) and are licensed by regulatory bodies such as the FDA and EMA.
Market Influence:
Given GSK's brand recognition and extensive distribution networks, it remains the dominant supplier for VIGPODER, especially in Western markets.
2. Hetero Labs Ltd.
Overview:
Hetero, an Indian pharmaceutical giant, produces generic versions of valaciclovir, including formulations similar to VIGPODER. Their focus on cost-effective manufacturing caters to emerging markets.
Manufacturing Capabilities:
Hetero's facilities in Hyderabad and other locations hold approvals from USFDA, EUGMP, and DCGI, supporting global export commitments.
Market Influence:
Hetero's products compete on price and availability, acting as a significant supplier, especially in South Asia and Africa.
3. Mylan (now part of Viatris)
Overview:
Mylan, incorporated into Viatris, has been a key player in producing generic antiviral drugs. They manufacture valaciclovir formulations supplied to multiple countries under various brand labels.
Manufacturing Capabilities:
Their facilities in the Philippines and the United States enable high-volume production, with certifications covering multiple regulatory agencies.
Market Influence:
Viatris' extensive distribution allows Mylan’s formulations to be integrated into a broad supply chain for VIGPODER equivalents.
4. CIPLA Limited
Overview:
CIPLA is renowned for affordable generics in antiviral medications. They produce valaciclovir formulations that meet international standards.
Manufacturing Capabilities:
CIPLA's formulations are manufactured in India, with export licenses to over 100 countries, including stringent markets like the US and Europe.
Market Influence:
As a major supplier of generic valaciclovir, CIPLA greatly influences availability in emerging markets.
5. Dr. Reddy’s Laboratories
Overview:
Dr. Reddy’s manufactures and supplies valaciclovir under various brand names, emphasizing quality and affordability.
Manufacturing Capabilities:
Their facilities in India and abroad comply with global GMP standards and possess USFDA and EMA approvals.
Market Influence:
Their role in the supply chain supports generic options comparable to VIGPODER in multiple regions.
Regulatory and Quality Considerations
The supply chain for VIGPODER depends heavily on regulatory compliance. Manufacturers must obtain approvals from health authorities like FDA (United States), EMA (European Union), PMDA (Japan), and DCGI (India). These approvals verify manufacturing quality, safety, and efficacy.
In particular, Indian manufacturers such as CIPLA, Dr. Reddy’s, and Hetero have successfully secured multiple international licenses, facilitating global distribution. Additionally, compliance with GMP and ISO standards ensures ongoing production quality.
Supply Chain Dynamics and Market Trends
-
Generic Expansion: The proliferation of generic manufacturers in India and China has increased the supply options for VIGPODER, fostering price competition and improved accessibility.
-
Patent Expiry and Entry of Generics: As patents on the original valaciclovir formulations expire, new entrants have emerged, amplifying the global customer base.
-
Regional Variability: While GSK remains dominant in Western markets, regional suppliers like Hetero and CIPLA primarily serve developing economies.
-
Manufacturing Scale-Up: Advances in recombinant DNA technology and process optimization have enabled manufacturers to scale production, reducing costs and meeting global demand, especially during health crises.
Challenges in the VIGPODER Supply Chain
- Regulatory Barriers: Differences in licensing, quality standards, and patent laws can delay market entry.
- Supply Disruptions: Raw material shortages, geopolitical issues, or manufacturing problems can create shortages.
- Price Pressures: The shift toward generics exerts downward pressure on pricing but demands cost-efficient scaling.
Conclusion
The supply of VIGPODER predominantly revolves around a core group of manufacturers—GSK, Hetero, Mylan/Viatris, CIPLA, and Dr. Reddy’s—each contributing through diverse manufacturing capacities and geographic reach. The generics market's fragmentation and regulatory alignments facilitate broader availability but require ongoing vigilance regarding quality assurance and supply stability.
Business professionals should monitor these players' regulatory statuses, capacity expansions, and regional market strategies to anticipate supply trends.
Key Takeaways
- GSK remains the principal supplier of VIGPODER, maintaining a strong patent-protected presence in global markets.
- Indian manufacturers such as Hetero, CIPLA, and Dr. Reddy’s are critical contributors to the generic supply chain, especially in emerging markets.
- Regulatory compliance, GMP adherence, and patent statuses heavily influence manufacturing and supply stability.
- The ongoing growth of generics due to patent expirations continues to diversify suppliers and lower prices.
- Strategic supply chain management requires monitoring manufacturing capacities, regulatory approvals, and geopolitical factors affecting raw material access.
FAQs
1. Who are the leading global suppliers of VIGPODER?
GSK is the primary manufacturer, with significant contributions from Indian generics manufacturers like Hetero, CIPLA, and Dr. Reddy’s.
2. How do regulatory approvals impact supply stability?
Regulatory certifications like USFDA, EMA, and DCGI ensure manufacturing quality, enabling products to reach international markets and preventing supply disruptions.
3. Are there regional differences in VIGPODER supply?
Yes. Western markets predominantly rely on GSK, while Asian and African markets depend more on Indian generics manufacturers for cost-effective options.
4. What role do patent laws play in the supply chain?
Patent expirations facilitate entry for generics, increasing competition, expanding supply, and reducing prices. Patent enforcement in various jurisdictions influences the timing and extent of generic manufacturing.
5. What are potential risks to VIGPODER supply continuity?
Risks include raw material shortages, regulatory delays, geopolitical issues, manufacturing capacity constraints, and quality compliance failures.
References
[1] GSK’s official website and product disclosures.
[2] Indian pharmaceutical industry reports (e.g., Pharamceutical Export Promotion Council).
[3] USFDA and EMA approvals for key manufacturing sites.
[4] Industry analysis reports on antiviral drug markets.
More… ↓
