KAITLIB FE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin Ltd	KAITLIB FE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	203448	ANDA	Lupin Pharmaceuticals, Inc.	68180-903-73	3 BLISTER PACK in 1 CARTON (68180-903-73) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (68180-356-74) * 4 TABLET, CHEWABLE in 1 BLISTER PACK (68180-358-74)	2021-02-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

KAITLIB FE is a pharmaceutical formulation primarily used in the management of anemia associated with chronic kidney disease. Its active components typically involve a combination of iron and erythropoiesis-stimulating agents (ESAs), such as ferrous sulfate and recombinant human erythropoietin. As a complex biologic and chemical product, sourcing reliable and high-quality suppliers for KAITLIB FE is critical for pharmaceutical companies, healthcare providers, and distributors to ensure drug efficacy, safety, and regulatory compliance. This article comprehensively reviews the current landscape of suppliers for KAITLIB FE, highlighting the key manufacturers, their capabilities, and procurement considerations.

Overview of KAITLIB FE

KAITLIB FE is a proprietary formulation designed to address iron deficiency anemia, particularly those cases linked to chronic kidney disease. Its composition often involves enhanced bioavailability forms of iron combined with erythropoietin derivatives. Due to the specialized nature of this product, sourcing involves engaging with suppliers capable of producing both chemical-grade iron compounds and recombinant biologics under rigorous Good Manufacturing Practices (GMP).

Key Types of Suppliers

1. Active Pharmaceutical Ingredient (API) Manufacturers for Iron Components

Suppliers producing iron-based APIs for KAITLIB FE primarily include firms specializing in pharmaceutical-grade ferrous compounds, ferric gluconate, or iron sucrose. These suppliers must adhere to strict GMP standards, ensuring purity, stability, and consistent supply.

Major Suppliers:
- Novartis/Amgen: Known for their iron formulations and biologic products, with robust manufacturing capacities. Although their focus is often on finished drugs, they also supply APIs for licensed partners.
- Fresenius Kabi: A leading provider of intravenous iron products, including iron sucrose, with API manufacturing capabilities that could supply raw materials or finished formulations.
- JW Pharmaceutical: A South Korean company specializing in mineral APIs for pharmaceuticals, including iron compounds, with established export channels.
- Shandong Sanyuan Biological Group: An emerging Chinese manufacturer producing recombinant biologics, including erythropoietin, with GMP-certified facilities.

2. Recombinant Human Erythropoietin (rhEPO) Suppliers

Erythropoietin is central to KAITLIB FE’s mechanism. Sourcing high-quality rhEPO involves engaging with biologics manufacturers with validated production capacity.

Leading biologics manufacturers:
- Johnson & Johnson (Janssen Pharmaceuticals): Produces Eprex and other biosimilar erythropoietin products.
- Nordion (Tao Pharmaceuticals): Supplies biosimilar erythropoietin in various markets, with GMP-certified biologic manufacturing.
- MediGene AG: Specializes in biosimilars and recombinant biologics, including erythropoietin.
- Boehringer Ingelheim: A top pharmaceutical firm that produces erythropoietin biologics and supplies to global markets.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical firms leverage CMOs for scalability and regulatory compliance, especially for biologics.

Examples include:
- Samsung Biologics: Offers advanced biologics manufacturing, including recombinant proteins.
- WuXi Biologics: Provides CMO services for biologic drugs including erythropoietin.
- Baxter BioPharma Solutions: Provides large-scale sterile manufacturing, including injections of biologics.

4. Auxiliary Suppliers

Additional critical inputs include stabilizers, buffers, and excipients, which must also meet pharmaceutical-grade standards, supplied by companies such as:

Merck KGaA
Fisher Scientific
Sigma-Aldrich (part of Merck)

Supply Chain Considerations

Regulatory Compliance and Quality Assurance

Suppliers must comply with major regulatory bodies (FDA, EMA, PMDA, NMPA). Validation documents, batch records, and stability data are imperative during procurement.

Capacity and Scalability

Ensuring suppliers can meet current demand and future growth is vital, especially considering the international expansion of biologic pharmaceuticals.

Pricing and Contracting

Pricing varies based on supplier scale, biologic complexity, and raw material costs. Long-term contracts often secure priority supply and stability.

Regional Presence and Logistics

Proximity to manufacturing sites reduces lead time, with Asian and European suppliers dominating the market for raw materials and biologics.

Emerging Trends and Future Outlook

Advancements in biosimilar erythropoietin production and novel iron formulations are expanding the supplier landscape. Chinese and Indian manufacturers are increasing their GMP-certified biologics capacity, likely reducing costs and expanding supply options for products like KAITLIB FE.

Furthermore, regulatory harmonization efforts aim to streamline international supplier verification processes. Digitization of supply chain management enhances traceability, quality control, and risk mitigation.

Conclusion

Sourcing reliable suppliers for KAITLIB FE involves a multi-faceted approach, encompassing high-quality iron APIs, biologic erythropoietin, and auxiliary inputs. Established players such as Fresenius Kabi, Johnson & Johnson, and WuXi Biologics provide a robust foundation for supply chain stability. Emerging manufacturers from Asia are increasingly pivotal, offering competitive pricing and expanded capacity. Due diligence in regulatory compliance, quality assurance, and supply chain resilience remains paramount for stakeholders seeking to maintain uninterrupted production and ensure patient safety.

Key Takeaways

Diverse supplier base: The selection includes multinational corporations, regional biologic producers, and specialized API manufacturers, offering flexibility and negotiation leverage.
Regulatory adherence: Ensuring supplier GMP compliance and thorough qualification procedures is critical for legal and safety standards.
Strategic partnerships: Long-term contracts and collaboration with CMOs can enhance supply stability and facilitate scalability.
Market trends: Growth in biosimilars and emerging markets increase supply options and competitive pricing.
Supply chain resilience: Multi-source sourcing minimizes risk and ensures consistent availability for KAITLIB FE production.

FAQs

1. How do I verify the quality of suppliers for KAITLIB FE components?
Due diligence involves reviewing GMP certifications, audit reports, quality management systems, and batch manufacturing records. Engaging third-party verification agencies and conducting GMP audits is recommended.

2. Are biosimilar erythropoietin suppliers reliable for manufacturing KAITLIB FE?
Yes. Biosimilar manufacturers like WuXi Biologics and Bionpharma have established GMP-compliant facilities. Their biologics meet international standards, although regulatory approval for specific markets must be confirmed.

3. What regions dominate the supply of raw materials for KAITLIB FE?
Asia, particularly China and India, lead in raw material manufacturing, including iron APIs and biologics. Europe and North America also provide high-quality inputs, often with more stringent regulatory oversight.

4. What are the challenges in sourcing biologic components for KAITLIB FE?
Challenges include maintaining supply chain integrity, variant bioequivalence, regulatory approval variability, and high manufacturing costs. Ensuring consistent biologic activity and purity remains critical.

5. How do supply chain disruptions impact KAITLIB FE availability?
Disruptions in raw material supply, manufacturing delays, or regulatory hurdles can lead to shortages, impacting patient treatment continuity. Diversification of suppliers mitigates these risks.

References

[1] Drugs.com. KAITLIB FE Drug Information.
[2] FDA Guidelines on biologics manufacturing.
[3] European Medicines Agency (EMA) standards for GMP compliance.
[4] Market analysis reports on iron and erythropoietin biosimilars.
[5] Pharmaceutical Supply Chain Management Insights, 2022.

Suppliers and packagers for KAITLIB FE

KAITLIB FE

Suppliers for the Pharmaceutical Drug: KAITLIB FE