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Suppliers and packagers for generic pharmaceutical drug: ADEFOVIR DIPIVOXIL
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ADEFOVIR DIPIVOXIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Apotex | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 205459 | ANDA | Apotex Corp. | 60505-3947-3 | 1 BOTTLE in 1 CARTON (60505-3947-3) / 30 TABLET in 1 BOTTLE | 2018-09-25 |
| Sigmapharm Labs Llc | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 202051 | ANDA | Sigmapharm Laboratories, LLC | 42794-003-08 | 1 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLE | 2013-09-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Adefovir Dipivoxil
Overview of Adefovir Dipivoxil as a Pharmaceutical Agent
Adefovir dipivoxil is an antiviral prodrug primarily used in the treatment of chronic hepatitis B virus (HBV) infections. Marketed under trade names such as Hepsera, it inhibits HBV DNA polymerase, reducing viral replication. Since its approval by the FDA in 2002, adefovir dipivoxil has been a critical component in antiviral therapy, with multiple generic manufacturers entering the market post-patent expiration. The drug’s global demand hinges on its availability from reputable suppliers adhering to stringent regulatory standards.
Global Supply Chain and Major Manufacturers
The supply of adefovir dipivoxil is concentrated among several key pharmaceutical companies globally, spanning from originators to generic manufacturers. These suppliers differ in terms of manufacturing capacity, geographic reach, regulatory compliance, and quality assurance systems.
Original Developers and Patent Holders
The origin of adefovir dipivoxil was attributed to Gilead Sciences, Inc., which developed and marketed the drug under its branded formulation Hepsera. Gilead holds the original patent rights, although patent expiry has facilitated the proliferation of generic versions.
Generic Manufacturers and Suppliers
Once patent protections expired, multiple generic pharmaceutical firms began manufacturing and distributing adefovir dipivoxil. These manufacturers are located in regions with robust pharmaceutical production capabilities, including India, China, and other emerging markets, as well as established regulatory jurisdictions such as the European Union and the United States.
Leading Suppliers and Market Participants
1. Hetero Drugs Ltd. (India):
Hetero is among the prominent global producers of adefovir dipivoxil, offering high-quality generic versions approved by various international regulatory bodies. The company has a comprehensive manufacturing facility compliant with WHO-GMP standards. Their product portfolio includes both bulk active pharmaceutical ingredient (API) and finished dosage forms.
2. Natco Pharma Ltd. (India):
A key player in antiviral APIs, Natco supplies adefovir dipivoxil with certifications for global distribution. Their API manufacturing process emphasizes purity, potency, and consistent supply, with active engagement in multinational supply chains.
3. Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
Hisun Pharma produces adefovir dipivoxil API and finished formulations, catering to both domestic and international markets. The company emphasizes quality control and regulatory compliance, including approval for various markets such as the EU and India.
4. Dr. Reddy’s Laboratories (India):
Dr. Reddy’s develops and supplies adefovir dipivoxil, ensuring adherence to regulatory standards. Their global supply network enhances availability through robust distribution channels.
5. Sun Pharmaceutical Industries Ltd. (India):
Sun Pharma offers adefovir dipivoxil API and finished forms, emphasizing affordability without compromising quality. They maintain GMP-certified facilities compliant with international standards.
6. Other Notable Suppliers:
Additional suppliers include Cipla, Mylan, and Amneal Pharmaceuticals, each contributing to the diversified supply landscape.
Factors Influencing Supplier Selection
- Regulatory Compliance: Suppliers must meet standards such as FDA, EMA, or WHO-GMP certifications to ensure quality and safety.
- Manufacturing Capacity: Sufficient production capacity is crucial to meet global demand, especially during surges or shortages.
- Pricing and Cost Competitiveness: Pricing strategies influence procurement decisions, especially in markets with price-sensitive healthcare systems.
- Supply Stability: Long-term supply agreements and diversified sourcing mitigate risk of shortages.
- Quality Assurance: Consistent quality control, stability data, and compliance with pharmacopeial standards are non-negotiable.
Regulatory and Quality Certification
Suppliers for adefovir dipivoxil must possess appropriate regulatory authorizations, including:
- US FDA approval or clearance for production facilities
- EU Good Manufacturing Practice (GMP) certification
- WHO-GMP certification for broader international acceptance
- ISO certifications focusing on quality management systems
Ongoing compliance ensures uninterrupted supply and minimizes the risk of counterfeit or substandard products entering the supply chain.
Supply Chain Challenges and Market Dynamics
The global supply chain for adefovir dipivoxil faces challenges such as:
- Regulatory hurdles in certain jurisdictions, delaying approval and distribution.
- Price sensitivity and competition among generic manufacturers leading to narrow profit margins.
- Manufacturing disruptions due to quality issues, geopolitical factors, or raw material shortages.
- Patent litigations or legal barriers may impact availability in certain markets.
Despite these challenges, a resilient supply of adefovir dipivoxil persists, largely driven by India’s burgeoning generic pharmaceutical industry and China's significant manufacturing base.
Future Outlook and Market Trends
Continued patent expirations and the adoption of biosimilars and generics are expected to further expand supplier options. Innovations in manufacturing processes and quality control technology bolster supply stability. Increasing regulatory harmonization and global trade agreements will facilitate smoother procurement pathways for healthcare providers.
Moreover, partnerships between originator firms and generic manufacturers can shape supply dynamics, influencing pricing and availability. Ensuring supply chain security remains vital amid growing demand from regions with high HBV prevalence.
Key Takeaways
- The supply landscape for adefovir dipivoxil is primarily composed of Indian and Chinese manufacturing firms, backed by rigorous regulatory certifications.
- Major suppliers such as Hetero, Natco, Zhejiang Hisun, Dr. Reddy’s, and Sun Pharma dominate the global market.
- Regulatory compliance, quality standards, manufacturing capacity, and supply stability are critical factors influencing purchasing decisions.
- Market challenges include regulatory delays, price competition, manufacturing disruptions, and legal barriers.
- The future of the adefovir dipivoxil supply chain will likely benefit from increased generic proliferation, technological advancements, and global regulatory harmonization.
FAQs
1. Is adefovir dipivoxil available as a generic product worldwide?
Yes. Post-patent expiration, numerous generic manufacturers, particularly in India and China, supply adefovir dipivoxil globally, adhering to international quality standards.
2. What are the primary regions sourcing adefovir dipivoxil?
Major sourcing regions include India, China, and other emerging markets, with Europe and North America primarily relying on imported generics.
3. How do I verify the authenticity and quality of adefovir dipivoxil suppliers?
Verify suppliers’ regulatory certifications such as FDA, EMA, or WHO-GMP, and request quality assurance documentation, batch testing reports, and validation certificates.
4. Are there any quality risks associated with sourcing from Indian or Chinese manufacturers?
While some concerns exist, reputable suppliers with verified certifications maintain rigorous quality controls. Due diligence and regular audits are essential.
5. What should healthcare providers consider when establishing supply agreements for adefovir dipivoxil?
Prioritize suppliers with consistent regulatory compliance, robust manufacturing capacity, reliable supply history, and competitive pricing.
Sources
[1] Gilead Sciences, Inc. - Hepsera product information.
[2] WHO guidelines on pharmaceutical quality standards.
[3] Market intelligence reports on antiviral drug manufacturing.
[4] Company websites and official certifications of Indian and Chinese pharmaceutical firms.
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