Suppliers and packagers for pitocin

pitocin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261	NDA	Endo USA, Inc.	42023-116-73	25 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL	2023-12-22
Ph Health	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261	NDA	Endo USA, Inc.	42023-116-83	25 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL	2023-12-22
Ph Health	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261	NDA	Endo USA, Inc.	42023-116-93	25 VIAL in 1 CARTON (42023-116-93) / 10 mL in 1 VIAL	2023-12-22

Suppliers for the Pharmaceutical Drug: PITOCIN

Last updated: July 27, 2025

Introduction

PITOCIN, a well-known brand name for the hormone oxytocin, is a critical pharmaceutical used primarily in obstetrics to induce or augment labor, control postpartum bleeding, and manage other gynecological conditions. As a peptide drug, oxytocin's production and supply chain involve a complex network of manufacturers, distributors, and regulatory authorities worldwide. This article explores key suppliers of PITOCIN, examining manufacturing sources, the global distribution framework, and the implications for stakeholders in pharmaceutical procurement and healthcare delivery.

Manufacturers of Pitocin (Oxytocin)

1. Ferring Pharmaceuticals

Ferring is a leading global biopharmaceutical company headquartered in Switzerland with a significant stake in manufacturing oxytocin. The company produces high-quality Pitocin formulations, supplying numerous countries under strict compliance with local regulatory standards. Its manufacturing facilities in Denmark and other regions adhere to Good Manufacturing Practices (GMP) standards, ensuring drug integrity and consistency.

2. Eli Lilly and Company

Historically, Eli Lilly was a pioneer in synthesizing oxytocin, with some formulations still available through licensing agreements. Although Eli Lilly has divested some of its vaccine and hormone portfolios, its previous contributions to oxytocin production have paved the way for continued manufacturing and innovation by other pharmaceutical firms.

3. Novartis / Sandoz (Now part of Novartis)

As a key producer of various peptide hormones, Sandoz's (a Novartis division) manufacturing facilities have historically supplied oxytocin products to several markets. Their focus on biosimilars and generics positions them as crucial suppliers, especially in regions where branded formulations face pricing or availability barriers.

4. Biotech and Generic Manufacturers

Numerous regional generic manufacturers actively produce oxytocin formulations to meet local demand, particularly in low- and middle-income countries (LMICs). These manufacturers often obtain licenses or generic rights through partnerships with original patent holders or via government procurement programs.

Regulatory and Quality Considerations

Due to their biological nature, oxytocin formulations must meet rigorous quality standards. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) oversee the approval and quality compliance of suppliers. WHO prequalification programs often include assessments of manufacturing facilities to ensure global supply of quality-assured Pitocin.

Global Distribution Framework

1. Distribution Networks

Pharmaceutical distributors and wholesalers, such as McKesson, Cardinal Health, and regional entities, facilitate the global dissemination of Pitocin. These networks ensure timely availability in hospitals, clinics, and pharmacies. In LMICs, UNICEF and the Pan American Health Organization (PAHO) often play pivotal roles in procurement and supply.

2. Public-Private Partnerships

Global health initiatives and government procurement agencies frequently partner with manufacturers to ensure affordable access. For instance, WHO maintains a prequalified list of oxytocin producers, guiding procurement in developing countries.

3. Supply Chain Challenges

Issues such as cold chain requirements, regulatory discrepancies among countries, and regional shortages impact the availability of Pitocin. Suppliers with robust logistics capabilities and regulatory compliance are better positioned to mitigate these challenges.

Market Dynamics and Competition

The oxytocin market demonstrates moderate competition, driven by patent expirations and the rise of biosimilars. Market entry barriers such as manufacturing complexity, quality assurance, and regulatory approval processes influence supplier diversity. Consequently, the landscape is consolidated among a few major global manufacturers, with regional generics addressing local needs.

Emerging Trends and Future Outlook

• Biosimilar Development: Increased focus on biosimilar oxytocin products aims to improve affordability and supply security, especially in resource-limited settings.
• Regulatory Harmonization: Efforts by WHO and regional agencies strengthen manufacturing standards, affecting supplier eligibility and market access.
• Supply Chain Innovation: Digital tracking and cold chain innovations improve reliability and transparency in Pitocin distribution.

Conclusion

The supply of PITOCIN (oxytocin) hinges on a limited but globally interconnected network of manufacturers, including Ferring Pharmaceuticals, Novartis/Sandoz, and regional generic producers. Ensuring quality, affordability, and consistent supply remains a priority for healthcare providers, regulators, and policymakers. As the market evolves with biosimilar entrants and improved supply chain technologies, stakeholders must monitor regulatory developments and supplier capacity to safeguard access to this vital drug.

Key Takeaways

• Major global suppliers include Ferring Pharmaceuticals and Novartis/Sandoz, with regional generic manufacturers filling local market gaps.
• Regulatory standards and WHO prequalification influence supplier eligibility and quality assurance.
• Supply chain challenges, especially in LMICs, impact drug availability; robust logistics and cold chain management are vital.
• Market trends favor biosimilar development, promoting increased affordability and supply diversity.
• Stakeholders should stay attuned to regulatory updates and technological innovations to optimize procurement strategies.

FAQs

1. Who are the leading manufacturers of PITOCIN globally?
   Ferring Pharmaceuticals and Novartis/Sandoz are the primary global producers of oxytocin formulations sold under the PITOCIN brand or as generics. Regional manufacturers also play a significant role in supplying local markets.

2. What are the quality standards required for oxytocin suppliers?
   Suppliers must meet GMP criteria set by regulatory agencies like the FDA and EMA. WHO prequalification also serves as a benchmark for quality in international procurement, especially for LMICs.

3. How do supply chain issues affect the availability of PITOCIN?
   Cold chain requirements, logistical limitations, and regulatory differences can cause delays or shortages, particularly in remote or resource-poor regions.

4. Are biosimilars impacting the oxytocin market?
   Yes, biosimilars are emerging as cost-effective alternatives, increasing competition, and improving access—especially in markets where patent exclusivity wanes or manufacturing barriers exist.

5. What role does the WHO play in ensuring global supply of PITOCIN?
   The WHO prequalifies manufacturers of oxytocin, guiding procurement in developing countries, and facilitating the standardization of quality and supply security.

References

[1] WHO. (2023). Prequalification Programme — Medicines. World Health Organization.
[2] Ferring Pharmaceuticals. (2023). Product Portfolio.
[3] Novartis. (2023). Biosimilar and Generic Product Data.
[4] U.S. FDA. (2023). Guidance for Industry: Biological Products and Drugs.
[5] PAHO. (2022). Procurement and Supply Management in Latin America.