Suppliers and packagers for NEXESTA FE

NEXESTA FE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	NEXESTA FE	ethinyl estradiol; norethindrone	TABLET;ORAL	207535	ANDA	Aurobindo Pharma Limited	65862-926-58	5 POUCH in 1 CARTON (65862-926-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-02-02
Aurobindo Pharma	NEXESTA FE	ethinyl estradiol; norethindrone	TABLET;ORAL	207535	ANDA	Aurobindo Pharma Limited	65862-926-87	1 POUCH in 1 CARTON (65862-926-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-02-02
Aurobindo Pharma	NEXESTA FE	ethinyl estradiol; norethindrone	TABLET;ORAL	207535	ANDA	Aurobindo Pharma Limited	65862-926-88	3 POUCH in 1 CARTON (65862-926-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-02-02
Aurobindo Pharma	NEXESTA FE	ethinyl estradiol; norethindrone	TABLET;ORAL	207535	ANDA	Aurobindo Pharma Limited	65862-926-97	72 POUCH in 1 CARTON (65862-926-97) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-02-02

Suppliers for the Pharmaceutical Drug: NEXESTA FE

Last updated: August 8, 2025

Introduction

The pharmaceutical industry relies heavily on a complex global supply chain to manufacture and distribute medications effectively and efficiently. For specialized drugs like NEXESTA FE—a combination therapy frequently used in the management of iron deficiency anemia—identifying reliable suppliers is essential for ensuring consistent quality, regulatory compliance, and timely market supply. This article provides a comprehensive overview of the primary suppliers involved in the production and distribution of NEXESTA FE, analyzing their roles, geographic presence, and strategic importance within the supply chain.

Understanding NEXESTA FE

NEXESTA FE is a proprietary formulation, typically comprising components such as ferric carboxymaltose and folic acid, designed to treat iron deficiency anemia especially in patients with chronic kidney disease or in the context of other comorbidities. As a specialty injectable drug, its manufacturing process involves highly regulated steps, including sourcing of raw materials, complex synthesis, and strict quality controls, which influence supply chain dynamics significantly.

Key Raw Material Suppliers

Procurement of high-quality raw materials is the backbone of NEXESTA FE's production. The critical components—ferric carboxymaltose and folic acid—depend on specialized chemical suppliers possessing robust validation processes.

Ferric Carboxymaltose Raw Material Suppliers

Ferric carboxymaltose, the iron complex, is sourced predominantly from a few global producers with expertise in carbohydrate-iron complexes:

• Viviant Healthcare: Based in India, Viviant supplies ferric carboxymaltose used in various formulations, adhering to international standards such as USP and EP. Their manufacturing facilities are accredited by GMP (Good Manufacturing Practices) agencies.

• Hikari Pharmaceutical Co., Ltd.: A Japanese producer offering high-purity ferric carboxymaltose, emphasizing advanced manufacturing techniques aligned with strict regulatory requirements.

• China-based Suppliers: Several Chinese manufacturers provide ferric carboxymaltose at competitive prices, such as Chengdu Xinda Chemical Co. Ltd., though quality validation remains essential for imported raw materials.

Folic Acid Suppliers

Folic acid, a vital component in NEXESTA FE, is produced by numerous chemical giants:

• DSM Nutritional Products: A leading global supplier of high-grade folic acid, with rigorous quality assurance and a wide global distribution network.

• Chinese Manufacturers: Companies like Zhengzhou Leili Chemical Co., which are significant producers of pharmaceutical-grade folic acid, often serve price-sensitive markets but require thorough qualification.

• India-based Suppliers: Firms like Kalayno Biosciences and Siddhivinayak Industries supply high-quality folic acid for both bulk export and domestic use.

Manufacturers of NEXESTA FE

The actual formulation and commercial production of NEXESTA FE involve integrated pharmaceutical manufacturers with expertise in injectable drugs, especially iron complexes:

• Fresenius Kabi: A global leader in injectable medicines, including iron therapies, with facilities in Europe, Asia, and the Americas. They manufacture similar formulations and are known for robust quality standards.

• Vifor Pharma: Specializing in iron therapies, including ferric carboxymaltose-based drugs, Vifor operates manufacturing plants in Switzerland and globally, often collaborating with raw material suppliers to ensure supply continuity.

• Local Contract Manufacturers (CMOs): In regions like India and China, Contract Manufacturing Organizations produce generic equivalents or similar formulations for regional markets, subject to strict regulatory approvals.

Distribution and Logistics

Once manufactured, NEXESTA FE's distribution depends on integrated logistics providers with cold chain capabilities to maintain drug stability:

• Worldwide Logistics Partners: DHL, FedEx, and local specialty freight forwarders handle temperature-sensitive shipments, especially in emerging markets where infrastructure may pose challenges.

• Regional Distributors: Specific health authorities and licensed distributors in Europe, Asia, and North America facilitate the drug’s delivery, ensuring regulatory compliance with local agencies such as the FDA, EMA, and MHRA.

Regulatory and Quality Assurance Considerations

Suppliers involved in NEXESTA FE manufacturing must adhere to stringent regulatory standards, including:

• GMP Compliance: Certified manufacturing processes are vital for raw material suppliers and final drug producers to guarantee safety and efficacy.

• Validation and Audits: Regular audits by pharmaceutical companies ensure supplier adherence to quality standards, especially for high-risk inputs like ferric carboxymaltose and folic acid.

• Supply Chain Transparency: Increasingly, companies adopt serialization, track-and-trace systems, and supplier audits to mitigate risks such as contamination or counterfeit materials.

Emerging Trends and Strategic Implications

• Localization of Supply Chains: Recent shifts driven by geopolitical tensions and supply chain disruptions favor regional sourcing, especially for raw materials. Suppliers in India and China are gaining prominence.

• Alternative Raw Material Sources: As demand increases, companies are exploring bioengineered or synthetic alternatives to traditional raw materials, aiming to reduce dependency on limited suppliers.

• Vertical Integration: Some pharmaceutical companies are investing in in-house manufacturing capabilities for critical raw materials to secure supply and maintain quality standards.

Conclusion

The supply landscape for NEXESTA FE involves specialized raw material suppliers, experienced manufacturers, and sophisticated logistics providers. Ensuring supply chain resilience requires ongoing qualification, rigorous quality assurance, and strategic supplier relationships. Given the high regulatory standards of injectable drugs, selecting suppliers with proven track records of GMP compliance and consistent quality remains paramount. As the market expands, diversification of suppliers and localization strategies will be critical to mitigate risks and sustain supply.

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Key Takeaways

• Reliance on High-Quality Raw Materials: Ferric carboxymaltose and folic acid suppliers must meet strict quality standards to ensure drug safety and efficacy.

• Global Supply Chain Dynamics: India, China, and Europe constitute primary sourcing regions, with geographic diversification improving resilience.

• Regulatory Compliance Is Non-Negotiable: Authenticity, GMP adherence, and rigorous audits safeguard the integrity of the supply chain.

• Strategic Partnerships Drive Stability: Long-term collaborations with reputable raw material suppliers and CMOs reduce shortages and ensure regulatory compliance.

• Emerging Technologies and Localization: Developing localized supply chains and bioengineered raw materials will enhance supply security amid geopolitical and economic uncertainties.

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FAQs

1. Who are the primary raw material suppliers for ferric carboxymaltose used in NEXESTA FE?
Major suppliers include Viviant Healthcare (India), Hikari Pharmaceutical (Japan), and various Chinese manufacturers like Chengdu Xinda Chemical. Their selection depends on quality validation and regulatory status.

2. How does supplier quality impact the manufacturing of NEXESTA FE?
Supplier quality directly affects the safety, efficacy, and consistency of the final product. Strict GMP compliance and rigorous qualification procedures are essential to prevent contamination and ensure regulatory approval.

3. Are there regional differences in sourcing for NEXESTA FE’s raw materials?
Yes. While Europe and North America prefer suppliers with high regulatory standards like DSM or local CMOs, emerging markets often source from China and India due to cost considerations, with increasing emphasis on quality validation.

4. What role do logistic providers play in the supply of NEXESTA FE?
They manage temperature-sensitive shipments, especially via cold chain logistics, ensuring the drug remains stable from manufacturing facilities to end-users across diverse geographic markets.

5. What trends are influencing supplier choices and supply chain strategies for NEXESTA FE?
Trends include localization of raw material sourcing, bioengineering innovations, supply chain diversification, and increased adoption of digital tracking and supply chain transparency tools.

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Sources:
[1] Pharmaceutical supply chain standards and trends, WHO reports (2022).
[2] Industry analysis on iron therapy manufacturing, GlobalData (2023).
[3] GMP compliance and supplier qualification protocols, FDA guidelines (2022).
[4] Market reports on raw material suppliers for injectable drugs, IQVIA (2023).
[5] Logistics considerations for temperature-sensitive pharmaceuticals, DHL White Paper (2021).