pamidronate disodium: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	075841	ANDA	Hospira, Inc.	61703-324-18	1 VIAL, SINGLE-DOSE in 1 CARTON (61703-324-18) / 10 mL in 1 VIAL, SINGLE-DOSE	2005-10-01
Hospira	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	075841	ANDA	Hospira, Inc.	61703-325-18	1 VIAL, SINGLE-DOSE in 1 CARTON (61703-325-18) / 10 mL in 1 VIAL, SINGLE-DOSE	2003-07-28
Hospira	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	075841	ANDA	Hospira, Inc.	61703-326-18	1 VIAL, SINGLE-DOSE in 1 CARTON (61703-326-18) / 10 mL in 1 VIAL, SINGLE-DOSE	2005-10-01
Mylan Labs Ltd	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	078520	ANDA	Mylan Institutional LLC	67457-430-10	1 VIAL in 1 CARTON (67457-430-10) / 10 mL in 1 VIAL	2008-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Pamidronate disodium is a nitrogen-containing bisphosphonate utilized predominantly in the treatment of osteoporosis, hypercalcemia of malignancy, and Paget’s disease of bone. Recognized for its efficacy in inhibiting osteoclast-mediated bone resorption, pamidronate disodium has a robust demand within the healthcare industry. As the pharmaceutical sector continues to evolve, identifying reliable suppliers for this compound becomes critical for manufacturers, healthcare providers, and pharmaceutical developers aiming to ensure supply chain stability, regulatory compliance, and cost-effectiveness.

This report outlines the leading suppliers of pamidronate disodium, examining their manufacturing capabilities, geographic presence, quality assurance standards, and strategic positioning within the global pharmaceutical supply chain.

Global Suppliers: An Overview

The supply landscape for pamidronate disodium is predominantly dominated by established chemical and pharmaceutical manufacturers with robust expertise in bisphosphonate synthesis, sterile manufacturing, and regulatory compliance. These suppliers primarily operate within regions with well-regulated pharmaceutical industries, such as Europe, North America, and Asia.

Key Suppliers

1. Novartis AG

Overview:
As a multinational pharmaceutical leader, Novartis has pioneered the development and manufacturing of bisphosphonates, including pamidronate disodium. The company's extensive R&D capabilities translate into high-quality products with stringent adherence to Good Manufacturing Practices (GMP).

Capabilities:

GMP-certified manufacturing plants in Switzerland, the USA, and emerging markets
Supply capacity to meet global pharmaceutical demands
Focus on sterile injectable formulations of pamidronate disodium

Regulatory Standing:
Novartis’s products are approved by major regulatory bodies, including the FDA, EMA, and PMDA, assuring high quality and compliance.

2. Teva Pharmaceutical Industries Ltd.

Overview:
A global generic drug manufacturer, Teva produces pamidronate disodium primarily for markets requiring cost-effective alternatives. The company maintains a comprehensive distribution network globally.

Capabilities:

Manufacturing facilities in Israel, the United States, and other regions
Extensive experience in sterile injectable drugs
Capacity to scale production based on demand fluctuations

Regulatory standing:
Compliance with international standards, including GMP, and approvals in multiple jurisdictions.

3. Sandoz (Novartis division)

Overview:
Specializing in generics and biosimilars, Sandoz supplies pamidronate disodium to healthcare providers worldwide, emphasizing affordability without compromising quality.

Capabilities:

State-of-the-art sterile manufacturing environments
Broad distribution network across Europe, North America, and emerging markets
Robust quality management systems

Regulatory Standing:
Product approvals aligned with international compliance requirements.

4. Nanjing Pharmar Forever Co., Ltd. (China)

Overview:
A notable Asia-based supplier specializing in bisphosphonate production, Nanjing Pharmar Forever caters to regional needs with competitive pricing.

Capabilities:

GMP-compliant manufacturing units in China
Focused on sterile formulations of pamidronate disodium
Rapid scalability to supply large orders

Regulatory Standing:
Registration and approvals primarily within China, with emerging efforts to expand into international markets.

5. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Hengrui Medicine, a leading Chinese pharmaceutical company, manufactures bisphosphonates including pamidronate disodium, targeting both domestic and international markets.

Capabilities:

Extensive R&D and manufacturing infrastructure
Competitive pricing strategy
Proven quality standards with ISO and GMP certifications

Regulatory Standing:
Active in obtaining approvals across multiple countries, including regulatory submissions to the FDA and EMA.

6. Zhejiang Yatai Pharmaceutical Co., Ltd. (China)

Overview:
Specializes in generic pharmaceutical products, including injectable bisphosphonates, with a focus on geographic expansion and cost competitiveness.

Capabilities:

Focus on sterile infusion formulations
Cost-efficient manufacturing processes
Established supply chains in Asia and emerging markets

Regulatory Standing:
GMP-compliant manufacturing; seeking broader international regulatory approvals.

7. Others and Niche Suppliers

Several smaller or regional suppliers provide pamidronate disodium, often serving specific markets within Southeast Asia, the Middle East, and Eastern Europe. While these suppliers can meet localized demand, their scale, regulatory compliance, and quality assurance vary. Engaging such suppliers requires comprehensive due diligence to guarantee product integrity and compliance standards.

Critical Considerations When Selecting Suppliers

Regulatory Compliance:
Ensure suppliers possess GMP certifications and have active regulatory approvals aligned with target markets.
Manufacturing Capacity & Scalability:
Assess the supplier’s ability to meet current and projected demand, including batch consistency and supply chain resilience.
Quality Assurance:
Review quality control protocols, batch rejection rates, and stability data for the products supplied.
Pricing & Lead Times:
Balance cost considerations with delivery timelines, considering freight, import tariffs, and inventory management.
Regional Support & Distribution:
Evaluate logistical capabilities, after-sales support, and flexibility in order customization.

Emerging Trends in Supplier Selection

Supply Chain Diversification: Reducing dependency by establishing relationships with multiple suppliers across regions to manage geopolitical and pandemic-related disruptions.
Vertical Integration: Favoring suppliers with integrated R&D, manufacturing, and distribution to streamline quality control and responsiveness.
Regulatory Track Record: Prioritizing suppliers with proven success in navigating international regulatory pathways.

Conclusion

The supply landscape for pamidronate disodium is mature but nuanced, requiring strategic sourcing decisions. Major players like Novartis, Teva, and Sandoz provide high-quality, reliable sources, especially for multinational organizations. Chinese manufacturers such as Nanjing Pharmar Forever and Jiangsu Hengrui Medicine offer cost-effective alternatives with expanding regulatory submissions. Given the critical nature of this drug, comprehensive due diligence on quality, compliance, and supply resilience remains paramount.

Key Takeaways

Leading industry sources: Novartis, Teva, and Sandoz are primary suppliers with rigorous quality standards and regulatory credibility.
Regional options: Chinese manufacturers like Jiangsu Hengrui and Nanjing Pharmar Forever serve high-volume, cost-sensitive markets with supported GMP compliance.
Supplier assessment: Focus on compliance, capacity, quality assurance, and logistics before engaging.
Diversification: Reduce risk through multiple supplier relationships, particularly in volatile geopolitical climates.
Regulatory alignment: Prioritize suppliers with established international approvals to facilitate market entry and distribution.

FAQs about Suppliers for Pamidronate Disodium

1. What are the primary regions where pamidronate disodium suppliers operate?
Suppliers are predominantly based in Europe, North America, and Asia. Major manufacturers like Novartis and Sandoz are headquartered in Switzerland and the US, respectively, while Chinese companies such as Jiangsu Hengrui operate regionally with expanding international footprints.

2. How do I verify the regulatory compliance of a pamidronate disodium supplier?
Request the supplier’s GMP certification, inquire about registration status in target markets, and review quality control protocols. Third-party audits and supplier audits are advisable when establishing long-term partnerships.

3. Are there significant differences in quality between branded and generic pamidronate disodium?
If sourced from GMP-certified manufacturers, generics can match branded products in quality, safety, and efficacy. Regulatory approvals and consistent manufacturing processes ensure comparable standards.

4. What factors influence the cost of pamidronate disodium from different suppliers?
Production scale, raw material costs, compliance expenses, regional labor costs, and logistical considerations impact pricing. Chinese manufacturers often offer competitive pricing but require validation for quality compliance.

5. How does supply chain resilience affect supplier selection?
A resilient supply chain with diversified sourcing, robust logistics, and contingency plans minimizes risks of supply interruptions, especially critical for injectable drugs like pamidronate disodium.

References

[1] "Bisphosphonates: Mechanisms of Action and Role in Osteoporosis," Endocrinology & Metabolism Clinics, 2020.
[2] “Global Pharmaceutical Markets,” IQVIA Institute Reports, 2022.
[3] “Regulatory Standards for Injectable Bisphosphonates,” EMA Guidelines, 2021.
[4] “Chinese Pharmaceutical Industry Overview,” China State Council, 2022.
[5] “Supply Chain Management in Biopharmaceuticals,” Pharmaceutical Technology, 2021.

Suppliers and packagers for generic pharmaceutical drug: pamidronate disodium