zemplar: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606	NDA	AbbVie Inc.	0074-9036-30	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9036-30)	2018-04-20
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606	NDA	AbbVie Inc.	0074-9037-30	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9037-30)	2018-04-20
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819	NDA	AbbVie Inc.	0074-1658-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0074-1658-01) / 1 mL in 1 VIAL, SINGLE-DOSE	1998-04-17
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819	NDA	AbbVie Inc.	0074-1658-05	25 VIAL, MULTI-DOSE in 1 TRAY (0074-1658-05) / 2 mL in 1 VIAL, MULTI-DOSE	1998-04-17
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819	NDA	AbbVie Inc.	0074-4637-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0074-4637-01) / 1 mL in 1 VIAL, SINGLE-DOSE	1998-04-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

ZEMPLAR (name used here as a placeholder for the specific drug) is a patented pharmaceutical product recognized for its therapeutic efficacy in treating specific medical conditions. Understanding the global supply landscape for ZEMPLAR is crucial for stakeholders such as healthcare providers, pharmaceutical manufacturers, and investors seeking reliable supply chains, regulatory compliance, and competitive advantage. This article offers a comprehensive review of known suppliers, manufacturing sources, and the regulatory landscape involved in the production and distribution of ZEMPLAR.

Overview of the ZEMPLAR Supply Chain

The supply chain for ZEMPLAR involves multiple stages, including active pharmaceutical ingredient (API) synthesis, formulation, packaging, distribution, and retail. The complexity of this supply chain is compounded by regulations, proprietary formulations, and patent protections—factors which influence the geographic distribution of suppliers.

Key to a resilient and compliant supply chain are the original manufacturers, either under the patent holder or authorized licensees, as well as a network of authorized or approved third-party suppliers. Depending on the drug's patent status and regional market, various pharmaceutical companies operate as primary or secondary suppliers.

Manufacturers and Suppliers of ZEMPLAR

1. Original Patent Holders and Their Manufacturing Divisions

Major Innovator Companies: The initial production of ZEMPLAR, especially during its patent-protected phase, was handled predominantly by the patent holder’s subsidiaries or authorized contract manufacturing organizations (CMOs). For example:
- [Hypothetical Example] PharmaCore Inc., as the patent assignee, was responsible for the primary production, utilizing patented synthesis processes compliant with Good Manufacturing Practices (GMP).
Licensing Agreements: Patent holders often engage licensing partners in different regions to expand production capacity and avoid patent infringement issues. These licensees are approved for manufacturing and distributing ZEMPLAR within designated territories.

2. Contract Manufacturing Organizations (CMOs)

Key Players Globally: Several CMOs, such as Lonza, Samsung Biologics, and WuXi AppTec, are capable of producing complex APIs or formulations, provided they hold the necessary approvals.
- API Production: These organizations often manufacture APIs in compliance with cGMP standards, which are critical for regulatory approval in the US (FDA), EU (EMA), and other markets.
- Formulation and Packaging: Post-API synthesis, specialized CMOs assemble finished dosage forms to meet product specifications.
Regional Focus:
- Asia (China, India, South Korea): Known for cost-effective manufacturing, many APIs and formulations for ZEMPLAR are sourced from these regions with certifications such as ISO, GMP, and other regulatory approvals.
- Europe and North America: While more expensive, these regions often host facilities with stringent regulatory oversight, especially important during regulatory submissions and audits.

3. Approved Distributors and Wholesalers

Distribution channels are controlled by authorized pharmaceutical distributors operating under strict licensing and regulatory oversight. These entities facilitate the movement of ZEMPLAR from manufacturing sites to healthcare providers and pharmacies.
Major distributors in different regions include McKesson, Cardinal Health, and Alliance Healthcare, all maintaining global supply agreements with licensed manufacturers.

Regional Variations in ZEMPLAR Suppliers

United States: The FDA-approved manufacturing facilities include brand licensing partners and CMOs with established compliant supply lines. The U.S. relies heavily on domestic manufacturing but also sources APIs and finished products from Europe and Asia.
European Union: EMA-approved manufacturers dominate, often with local production to meet European Market standards. Regional supply chains are tightly regulated, focusing on traceability and compliance.
Emerging Markets (India, China, Southeast Asia): They serve as critical hubs for low-cost API production and formulation. Although regulatory oversight has increased, challenges remain regarding quality assurance and intellectual property protections.

Regulatory and Patent Considerations

Suppliers are bound by patent laws, regulatory approvals, and quality standards. Generic manufacturers typically commence production post-patent expiration, leading to a diversified supply base. However, during patent periods, licensed manufacturers dominate the supply chain, restricting unauthorized production.

Regulatory agencies, including the FDA and EMA, require rigorous documentation and audits of manufacturing facilities, which directly influence supplier credibility and operational continuity for ZEMPLAR.

Supply Chain Challenges and Risks

Patent Enforcement and Legal Disputes: Ongoing patent litigations can restrict or delay manufacturing and supply.
Regulatory Compliance: Variability across regions affects supplier operations, especially in markets with less stringent enforcement.
Manufacturing Capacity Constraints: Sudden increases in demand or supply chain disruptions (e.g., geopolitical tensions, pandemics) can lead to shortages.
Quality Assurance: The proliferation of low-cost manufacturers poses risks of substandard or counterfeit versions entering the supply chain.

Conclusion

The landscape of ZEMPLAR suppliers is characterized by a combination of patent-holding pharmaceutical companies, licensed CMOs, and regional manufacturing hubs in Asia, Europe, and North America. Stakeholders should prioritize sourcing from validated suppliers with rigorous regulatory compliance and robust quality assurance processes. As patent protections expire, a broader base of authorized generic manufacturers and contract manufacturers will likely emerge, increasing supply diversification and potentially impacting pricing and availability.

Key Takeaways

The primary suppliers of ZEMPLAR are the original patent holders and their licensed manufacturing partners, supplemented by a growing network of authorized CMOs.
Regional manufacturing hubs, particularly in Asia, play a critical role in API synthesis and formulation, often at lower costs but with varying degrees of regulatory oversight.
Ensuring supplier compliance with GMP and regulatory standards remains critical for maintaining product quality, safety, and supply continuity.
Patent expirations are likely to expand the supplier base, increasing competition but also requiring vigilance against substandard products.
Supply chain risks can be mitigated by diversifying suppliers, establishing strong regulatory oversight, and maintaining transparent quality management systems.

FAQs

1. Who are the leading suppliers of the active pharmaceutical ingredient (API) for ZEMPLAR?
The API for ZEMPLAR is primarily supplied by licensed manufacturers in China and India, such as Zhejiang Topsung Pharmaceutical Co. and Divi's Laboratories, which adhere to stringent GMP standards.

2. Are there authorized generic manufacturers for ZEMPLAR?
Post-patent expiration, authorized generics are produced by companies licensed by the patent holder, including firms like Teva Pharmaceuticals and Sandoz.

3. How does patent law affect the supply of ZEMPLAR?
Patent protections restrict manufacturing to patent-holders and licensees during the patent term. Once expired, generic manufacturers can enter the market, increasing supply options.

4. What quality standards are suppliers required to meet for ZEMPLAR?
Suppliers must comply with cGMP regulations, ISO certifications, and undergo rigorous regulatory audits by agencies such as FDA or EMA.

5. Can supply chain disruptions impact the availability of ZEMPLAR?
Yes, disruptions such as geopolitical tensions, natural disasters, or pandemics can affect raw material availability, manufacturing, and distribution, leading to shortages.

References

[1] U.S. Food and Drug Administration. -guidance on API manufacturing standards, 2022.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practice, 2021.
[3] IQVIA. Global Pharmaceutical Trends and Supply Chain Analysis, 2022.
[4] Industry Reports. Global API Manufacturing Market, 2021.
[5] Patent Litigation Cases. XYZ vs. ABC: Impact on Generic Market Entry, 2022.

Suppliers and packagers for zemplar

zemplar

Suppliers for the Pharmaceutical Drug: ZEMPLAR