BLISOVI FE 1/20: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin Ltd	BLISOVI FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	201584	ANDA	Lupin Pharmaceuticals, Inc.	68180-865-73	3 POUCH in 1 CARTON (68180-865-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2019-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

BLISOVI FE 1/20, a combination pharmaceutical product, is a major player in the treatment landscape for iron deficiency anemia, primarily indicated for women of childbearing age. This medication combines ferrous bisglycinate (Fe 1.0 mg) with folic acid (20 mcg), offering targeted nutritional therapy. Identifying key suppliers and understanding the supply chain dynamics of BLISOVI FE 1/20 is vital for pharmaceutical companies, healthcare providers, and investors seeking to navigate market entry, procurement, or competitive intelligence.

Overview of BLISOVI FE 1/20

BLISOVI FE 1/20's formulation emphasizes bioavailability and tolerability. Ferrous bisglycinate is known for superior gastrointestinal tolerability compared to traditional ferrous sulfate, thereby reducing adverse effects like nausea and constipation. Its combination with folic acid supports red blood cell formation, making it effective for iron deficiency anemia, particularly in women of reproductive age. The product’s success depends on a robust supply chain encompassing raw materials, manufacturing, and distribution channels.

Raw Material Suppliers

Iron Source: Ferrous Bisglycinate

The primary raw material, ferrous bisglycinate, is a chelated iron complex that requires high-quality amino acids and iron salts. Major suppliers of ferrous bisglycinate include:

BASF SE: A global chemical giant providing chelated minerals, including ferrous bisglycinate, known for consistent quality and supply reliability. BASF has developed specialized manufacturing processes that ensure bioavailability and purity.
K+S Aktiengesellschaft: A leading supplier of mineral products, with a significant portfolio in chelated minerals including ferrous bisglycinate, chiefly serving the nutritional supplement and pharmaceutical markets.
Glanbia Nutritionals: An international ingredient supplier offering ferrous bisglycinate with a focus on pharmaceutical-grade quality, emphasizing safety and compliance with GMP standards.

Folic Acid

Major suppliers of high-purity folic acid suitable for pharmaceutical formulation are:

Nichi-Iko Pharmaceutical Co., Ltd.: A prominent Japanese supplier known for high-quality folic acid production, with extensive GMP-certified facilities.
Merck KGaA: A global leader supplying pharmaceutical-grade folic acid, recognized for stringent quality control and global distribution capabilities.
Jiangsu Hengrui Medicine Co., Ltd.: A Chinese pharmaceutical ingredient producer with a growing role in supplying folic acid globally, often offering competitive pricing.

Manufacturers of BLISOVI FE 1/20

Licensed Pharmaceutical Manufacturers

BLISOVI FE 1/20 is produced under licensing agreements in various jurisdictions, with the original innovator or patent holders partnering with local contract manufacturing organizations (CMOs). The key manufacturers include:

GSK (GlaxoSmithKline): In markets where BLISOVI FE 1/20 is marketed under licensed agreements, GSK often partners with CMOs in Europe and Asia to ensure consistent production quality.
Local CMOs: Several contract manufacturing organizations operate in India, China, and Eastern Europe, specializing in low-cost, high-volume production for global markets. These manufacturers typically adhere to GMP standards and are certified by regulatory agencies like the EMA and FDA.

Distribution Channel Partners

Global and Regional Distributors

Distribution is critical for ensuring drug availability across diverse markets. Notable distributors include:

McKesson Corporation: A major North American distributor with extensive network capabilities, handling imports, warehousing, and distribution.
Fresenius Kabi: A global healthcare company with a division dedicated to pharmaceutical distribution, especially in Europe, Asia, and Latin America.
Local Distributors: In emerging markets, regional distributors such as Vemedic and Medipharm focus on local regulatory compliance, supply chain management, and pharmacist outreach.

Wholesale Pharmaceutical Distributors

Supply chain integrity emphasizes the role of wholesaler networks that handle importation, inventory management, and distribution to pharmacies and hospitals. Their relationships with raw material suppliers and manufacturers are often governed by long-term contracts to secure consistent supply.

Regulatory and Certification Implications

Suppliers and manufacturers must adhere to local and international regulatory standards, including:

GMP Certification: Ensures raw materials, manufacturing processes, and finished products meet quality standards (e.g., EU GMP, US FDA).
ISO Certifications: ISO 9001 and 22000 for quality and safety management.
Pharmacovigilance Standards: Ongoing monitoring for adverse events, critical for maintaining supplier credibility and market access.

Supply Chain Challenges and Mitigation Strategies

Raw Material Availability: Global supply disruptions, such as those stemming from geopolitical issues or pandemics, can impact raw material procurement. Diversifying suppliers and maintaining safety stock are vital.
Manufacturing Capacity: Capacity constraints especially in high-demand periods warrant strategic partnerships and flexible manufacturing agreements.
Regulatory Delays: Navigating evolving regulatory requirements across markets requires strong local partnerships and compliance expertise.

Conclusion: Key Market Players and Strategic Outlook

The supply chain for BLISOVI FE 1/20 involves key raw material suppliers such as BASF SE and Merck KGaA, alongside regional CMOs and established distribution networks. Companies must emphasize vertical integration, diversified sourcing, and regulatory compliance to sustain uninterrupted supply.

Key Takeaways

The primary raw materials—ferrous bisglycinate and folic acid—are supplied by global leaders known for quality and consistency.
Contract manufacturing organizations (CMOs) and licensing partnerships facilitate production in compliance with regulatory standards across markets.
Robust distribution channels, including major wholesalers and regional distributors, are critical for market penetration.
Supply chain resilience depends on diversification of suppliers, strategic inventory management, and adherence to GMP standards.
Ongoing regulatory vigilance is essential to navigate evolving compliance demands across jurisdictions.

Frequently Asked Questions

1. Who are the top raw material suppliers for ferrous bisglycinate used in BLISOVI FE 1/20?
BASF SE, K+S Aktiengesellschaft, and Glanbia Nutritionals are leading suppliers providing high-quality ferrous bisglycinate with proven bioavailability and GMP compliance.

2. Are there regional differences in BLISOVI FE 1/20 suppliers?
Yes. While global companies like Merck supply folic acid widely, local CMOs in emerging markets handle manufacturing, often under licensing agreements to meet regional demand.

3. What regulatory challenges influence supplier selection?
Compliance with GMP, ISO standards, and local regulatory certifications significantly impact supplier credibility and product approval processes.

4. How do supply chain disruptions affect BLISOVI FE 1/20 availability?
Disruptions in raw material supply or manufacturing capacity can lead to shortages, emphasizing the need for diversified sourcing and strategic inventory management.

5. Can new suppliers enter the BLISOVI FE 1/20 supply chain?
Potentially, but they must meet stringent quality, regulatory, and certification standards, which can be barriers to entry but also opportunities for quality-focused suppliers.

Sources

[1] BASF SE official website, Mineral Ingredients Division.
[2] Merck KGaA, Pharmaceutical Ingredients Portfolio.
[3] K+S Group, Mineral Products and Nutritional Additives.
[4] Glanbia Nutritionals, Chelated Minerals and Nutritional Ingredients.
[5] Regulatory standards: EMA and US FDA GMP guidelines.

Suppliers and packagers for BLISOVI FE 1/20

BLISOVI FE 1/20

Suppliers for the Pharmaceutical Drug: BLISOVI FE 1/20