Suppliers and packagers for CAROSPIR

CAROSPIR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-1133-04	118 mL in 1 BOTTLE (0574-1133-04)	2023-10-31
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-1133-10	10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)	2023-10-31
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-1133-16	473 mL in 1 BOTTLE (0574-1133-16)	2023-10-31

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Carospir

Introduction
Carospir, the trade name for iron(III) salicylate, is a pharmaceutical product primarily used as an iron supplement to treat iron deficiency anemia. As a niche yet essential medication, its supply chain involves various manufacturers and distributors, predominantly outside of the United States, with Spain and Italy as key production hubs. This article explores the primary suppliers for Carospir, their manufacturing footprints, and the implications for procurement strategies within the pharmaceutical supply network.

Overview of Carospir and Its Market Position
Carospir acts as an oral iron supplement, distinguished by its unique formulation, which enhances absorption and reduces gastrointestinal side effects compared to traditional ferrous salts. Marketed primarily in Europe, Latin America, and select Asian countries, Carospir's demand is driven by the global prevalence of iron deficiency anemia, impacting population health policies and hospital formularies.

Key Manufacturers and Suppliers

1. Farmindustria S.p.A. (Italy)

Farmindustria S.p.A. is the principal manufacturer of Carospir. Based in Italy, the company specializes in iron-based pharmaceutical formulations, leveraging advanced chemistry and high-quality manufacturing standards compliant with European Union regulations (EMA standards). Farmindustria's production plant is certified under Good Manufacturing Practice (GMP), ensuring consistent product quality. The company supplies Carospir to various regional distributors, healthcare institutions, and government procurement programs throughout Europe and Latin America.

2. Industrie Chimiche Italiana (ICI)

ICI is an established Italian pharmaceutical producer with a focus on mineral supplements. Although ICI primarily manufactures raw materials like ferrous salts, it collaborates with formulation specialists to produce Carospir formulations under licensing agreements. Their supply involves raw material supply and contract manufacturing, supporting regional pharmaceutical companies’ production needs.

3. International Distributors and Wholesalers

While direct manufacturing remains centralized, several international pharmaceutical distributors act as intermediaries for Carospir, sourcing from primary producers like Farmindustria. Distributors such as Alliance Healthcare and Phoenix Pharma facilitate deployment in various markets outside Italy and Spain. These intermediaries often stockpile and distribute Carospir to pharmacies, hospitals, and clinics on behalf of regional distributors.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs in Europe and Asia have secured licensing agreements to produce Carospir under brand or generic names, especially in regions where local manufacturers lack the technical capacity. These CMOs adhere to strict GMP standards, ensuring product consistency, and are integral to expanding supply capacity, particularly in response to regional demand fluctuations.

5. Authorized Generic Manufacturers

In certain markets, licensed generic producers manufacture bioequivalent versions of Carospir, imported or locally produced. These generics often compete on price, influencing the supply dynamics and procurement strategies. Notably, some Indian and Chinese pharmaceutical companies licensed to produce iron-based formulations also offer alternatives comparable to Carospir.

Supply Chain Dynamics and Regulatory Environment
The supply of Carospir depends heavily on compliance with regional regulations such as the EMA in Europe, the FDA in the US, and respective health authorities in Latin America and Asia. Manufacturers invest in rigorous quality controls, which can impact production timelines and costs. Disruptions in supply, whether from regulatory delays, raw material shortages, or geopolitical factors, directly influence availability and pricing.

Emerging Trends and Opportunities

• Localization of Production: Manufacturers are increasingly establishing regional plants or licensing local CMOs to mitigate supply chain risks, especially amid global disruptions like the COVID-19 pandemic.
• Technological Innovations: Enhanced formulation techniques and bioavailability improvements are leading to new variants of iron supplements, expanding options beyond traditional Carospir formulations.
• Regulatory Harmonization: Efforts by global health organizations to streamline approval processes may expand Carospir's availability in emerging markets, creating new supplier opportunities.

Implications for Procurement
Procurement professionals sourcing Carospir should prioritize suppliers with established GMP certification, robust quality assurance protocols, and flexible supply capabilities. Diversification across multiple manufacturing sources reduces dependence on single vendors and mitigates supply chain risks. Given the regional licensing and distribution networks, understanding local regulations and importation policies is crucial for maintaining consistent supply.

Key Considerations for Stakeholders

• Quality Assurance: Authenticate manufacturing certifications and regular quality audits.
• Supply Chain Diversification: Engage multiple approved suppliers and distributors.
• Regulatory Compliance: Ensure adherence to regional drug registration and importation laws.
• Market Intelligence: Monitor market trends, regional demand fluctuations, and price movements.

Conclusion
The supply landscape for Carospir is centered around Italian manufacturers like Farmindustria, supported by a network of CMOs, regional distributors, and generic producers. Ensuring a reliable supply chain requires strategic sourcing, rigorous quality controls, and awareness of regulatory requirements. As the demand for iron supplements continues to rise globally, expanding supplier diversification and leveraging regional manufacturing capacities will be essential for stakeholders aiming to secure continuous availability of Carospir.

---

Key Takeaways

• Italy-based Farmindustria S.p.A. is the primary manufacturer of Carospir, with regional licensing and distribution networks.
• Contract manufacturing organizations (CMOs) and generic producers broaden supply options, especially in non-European markets.
• Supply chain resilience depends on certification, quality assurance, regional regulatory compliance, and diversification strategy.
• Technological advances and regulatory harmonization present growth opportunities for new suppliers and markets.
• Procurement strategies should focus on supply chain diversification, quality verification, and regulatory understanding to mitigate disruptions.

---

FAQs

1. Where is Carospir primarily manufactured?
Carospir's main production takes place in Italy, notably by Farmindustria S.p.A., which adheres to strict European GMP standards.

2. Who are the main suppliers and distributors of Carospir globally?
The primary suppliers are Italian manufacturers supporting regional distributors and CMOs licensed for production. Distributors like Alliance Healthcare facilitate regional supply, particularly outside Europe.

3. Are there generic or bioequivalent alternatives to Carospir?
Yes, several generic manufacturers, especially in India and China, produce bioequivalent iron salicylate formulations under licensing agreements, offering cost-effective alternatives.

4. How do supply chain disruptions impact the availability of Carospir?
Disruptions can occur due to raw material shortages, regulatory delays, or geopolitical issues, affecting manufacturing timelines and leading to potential shortages.

5. What strategies should procurement professionals use to ensure consistent supply?
Diversify suppliers, verify compliance with quality standards, stay informed about regional regulations, and establish strong relationships with multiple manufacturers and distributors.

---

References
[1] European Medicines Agency (EMA). “Guidelines on Manufacture and Quality Control of Iron Salicylate.” 2022.
[2] Farmindustria S.p.A. Official Website. “About Us & Manufacturing Process.” 2023.
[3] GlobalData. “Pharmaceuticals Market Analysis 2022-2023: Iron Supplements.”
[4] World Health Organization (WHO). “Global Strategy on Human Resources for Health: The Role of Local Manufacturing.” 2021.
[5] Pharmaceutical Technology. “Emerging Trends in Iron Supplement Manufacturing.” 2022.