Share This Page
Suppliers and packagers for generic pharmaceutical drug: IDARUBICIN HYDROCHLORIDE
✉ Email this page to a colleague
IDARUBICIN HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | IDAMYCIN PFS | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2576-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 1997-02-17 |
| Pfizer | IDAMYCIN PFS | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2576-91 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-91) / 5 mL in 1 VIAL, SINGLE-DOSE | 1997-02-17 |
| Pfizer | IDAMYCIN PFS | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2586-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2586-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 1997-02-17 |
| Pfizer | IDAMYCIN PFS | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2586-91 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2586-91) / 10 mL in 1 VIAL, SINGLE-DOSE | 1997-02-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Idarubicin Hydrochloride
Introduction
Idarubicin Hydrochloride is a potent anthracycline antibiotic used primarily in chemotherapy treatments for acute myeloid leukemia (AML) and certain other cancers. Its efficacy depends heavily on reliable sourcing from qualified pharmaceutical suppliers, given the strict regulatory standards and manufacturing complexities involved. This article provides an in-depth overview of leading suppliers for Idarubicin Hydrochloride, highlighting their market positions, manufacturing capabilities, regulatory compliance, and regional presence.
Market Overview
As a specialized chemotherapeutic agent, Idarubicin Hydrochloride is produced by a limited number of pharmaceutical manufacturers globally. Due to the drug's chemical complexity and the necessity for high purity standards, suppliers often operate under stringent Good Manufacturing Practice (GMP) guidelines, with their products subject to rigorous quality control measures.
The global demand for Idarubicin Hydrochloride is driven by healthcare providers' need for effective AML treatment options. Typically, suppliers cater to regional markets spanning North America, Europe, Asia-Pacific, and emerging markets across Africa and Latin America.
Key Suppliers of Idarubicin Hydrochloride
1. Pfizer Inc.
Profile:
Pfizer, a global leader in pharmaceuticals, is a prominent supplier of chemotherapy agents, including Idarubicin Hydrochloride. The company benefits from an extensive R&D pipeline and robust manufacturing infrastructure.
Manufacturing & Supply Capabilities:
Pfizer manufactures Idarubicin Hydrochloride under strict GMP conditions, ensuring batch consistency and high purity. Its facilities adhere to international standards, allowing for reliable supply chains across multiple regions.
Regulatory Approvals & Compliance:
Pfizer’s products are approved by key regulatory agencies such as the U.S. FDA, EMA, and PMDA. Their global distribution network ensures compliance with regional standards.
Regional Presence:
Pfizer supplies Idarubicin Hydrochloride predominantly in North America and Europe, with regional warehouses to facilitate quick distribution.
2. Sun Pharmaceutical Industries Ltd.
Profile:
Sun Pharma, India-based and one of the world’s largest generic pharmaceutical manufacturers, produces a broad portfolio of chemotherapy agents, including Idarubicin Hydrochloride.
Manufacturing & Supply Capabilities:
Sun Pharma’s manufacturing plants are GMP-certified, complying with international standards, with a focus on affordability and availability in emerging markets.
Regulatory Approvals & Compliance:
Their products are approved in multiple jurisdictions, including the US, Europe, and India. The company's investment in quality control ensures product safety and efficacy.
Regional Presence:
Sun Pharma supplies Idarubicin Hydrochloride primarily across Asia-Pacific but also exports to Latin America, Africa, and select European markets.
3. Celltrion, Inc.
Profile:
South Korea-based Celltrion is known for biopharmaceuticals and biosimilars but also manufactures cytotoxic agents, including Idarubicin Hydrochloride, for regional use.
Manufacturing & Supply Capabilities:
With a focus on high-quality cytotoxic agents, Celltrion operates GMP-certified facilities with capabilities for large-scale production.
Regulatory Approvals & Compliance:
Celltrion’s drugs are approved by South Korea’s Ministry of Food and Drug Safety and are increasingly gaining approval in Southeast Asia and other regions.
Regional Presence:
Primarily serving Asian markets, with growing outreach into Europe.
4. Teva Pharmaceutical Industries Ltd.
Profile:
Israeli-based Teva is one of the world’s largest generic drug manufacturers, offering a range of oncology drugs, including Idarubicin Hydrochloride.
Manufacturing & Supply Capabilities:
Teva maintains GMP-certified manufacturing sites and emphasizes affordability and scalability.
Regulatory Approvals & Compliance:
Their products are broadly approved by major agencies, with a focus on ensuring consistent product quality.
Regional Presence:
Teva’s extensive distribution networks across North America, Europe, and emerging markets enable broad access to their chemotherapy agents.
5. Hospira (a Pfizer company)
Profile:
Specializing in hospital-based pharmaceuticals, Hospira offers Idarubicin Hydrochloride as part of its oncology range.
Manufacturing & Supply Capabilities:
Hospira emphasizes sterile manufacturing processes and rigorous quality controls aligned with global standards.
Regulatory Approvals & Compliance:
As a Pfizer subsidiary, Hospira's products meet all necessary regulatory standards globally.
Regional Presence:
Hospira’s focus is on hospital supplies, with distribution primarily in North America and Europe.
Additional Notable Suppliers
-
Mylan (now part of Viatris): Offers generic chemotherapies including Idarubicin Hydrochloride, mainly serving North American and European markets.
-
Qilu Pharmaceutical: A Chinese manufacturer with a growing portfolio of cytotoxic agents, including Idarubicin Hydrochloride, aiming at domestic and Asian export markets.
-
Indo American Biotech: An Indian manufacturer catering largely to regional and emerging markets.
Challenges and Considerations in Supplier Selection
Regulatory Compliance:
Given the critical nature of chemotherapeutic agents, procurement necessitates verifying suppliers’ adherence to GMP and obtaining necessary regulatory approvals (e.g., FDA, EMA, others).
Quality Assurance:
Strict quality control processes are essential to ensure batch-to-batch consistency, impurity profiles, and stability.
Supply Chain Reliability:
Considering global disruptions, suppliers with diversified manufacturing sites and robust logistics chains are preferred.
Pricing and Accessibility:
Balancing cost-efficiency with compliance standards is crucial, especially when sourcing for large-volume or hospital procurement.
Regional Regulatory Restrictions:
Some jurisdictions may require local manufacturing or approvals, affecting sourcing options.
Emerging Trends and Future Outlook
The global focus on biosimilars and generic oncology drugs is expanding supplier options for Idarubicin Hydrochloride. Regionally focused manufacturers are increasingly gaining approvals, boosting competition and accessibility. Additionally, advancements in manufacturing processes, such as continuous flow chemistry, promise improved yields, quality, and supply chain stability.
Pharmaceutical companies are also investing heavily in quality assurance to meet international standards, which may influence supplier relationships moving forward. Partnerships with contract manufacturing organizations (CMOs) offer flexibility and broaden the global supplier base.
Conclusion
Securing a reliable supplier of Idarubicin Hydrochloride requires careful evaluation of manufacturing standards, regulatory compliance, regional availability, and supply chain robustness. Leading manufacturers such as Pfizer, Sun Pharma, Celltrion, Teva, and Hospira represent the top-tier options, each with distinct strengths tailored to different markets.
Key considerations include verifying GMP certification, regulatory approvals, manufacturing capacity, and logistical capabilities to ensure uninterrupted supply of this critical chemotherapeutic agent.
Key Takeaways
- Global Leaders: Major pharmaceutical companies like Pfizer, Sun Pharma, and Teva dominate the supply landscape for Idarubicin Hydrochloride, offering high-quality products with extensive regulatory approvals.
- Regional Players: Manufacturers from Asia, such as Celltrion and Qilu Pharmaceutical, are expanding their roles, especially in emerging markets, offering cost-effective options.
- Regulatory Vigilance: Ensuring compliance with GMP standards and regional approvals is paramount to safeguard patient safety and legal conformity.
- Supply Chain Resilience: Due to the complexity of manufacturing chemotherapy drugs, suppliers with diversified production sites reduce procurement risks.
- Future Directions: Investment in biosimilars and innovative manufacturing processes will likely broaden supplier options and improve global access.
FAQs
1. What regulatory considerations should I prioritize when selecting a supplier for Idarubicin Hydrochloride?
Ensure the supplier has GMP certification, and that their products are approved by relevant regional regulatory agencies such as the FDA or EMA, to guarantee safety, efficacy, and compliance.
2. Are there cost-effective alternatives to brand-name suppliers for Idarubicin Hydrochloride?
Yes, generic manufacturers like Sun Pharma and Teva offer cost-effective options while adhering to international quality standards, suitable for regions with budget constraints.
3. How can I verify the quality of Idarubicin Hydrochloride sourced from international suppliers?
Request Certificates of Analysis (CoA), compliance documentation, and conduct independent analytical testing if necessary to verify purity, potency, and impurity levels.
4. Which regions have the highest supply reliability for Idarubicin Hydrochloride?
North America and Europe generally provide the most reliable supply chains due to strict regulatory oversight and established manufacturing infrastructures. Emerging markets are expanding access through regional manufacturers.
5. How might future developments impact suppliers of Idarubicin Hydrochloride?
Advancements in manufacturing technology, increased focus on biosimilar and generic oncology drugs, and regulatory harmonization are likely to diversify and strengthen the global supplier landscape.
Sources:
- Pfizer Annual Reports and Regulatory Filings
- Sun Pharma Official Website and Regulatory Approvals
- Celltrion Corporate Publications
- Teva Pharmaceutical Products Information
- Hospira Product Portfolio and Regulatory Certifications
More… ↓
