OXYTROL FOR WOMEN: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211	NDA	Allergan, Inc.	0023-9637-04	16 PATCH in 1 CARTON (0023-9637-04) / 4 d in 1 PATCH	2016-01-01
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211	NDA	Allergan, Inc.	0023-9637-08	32 PATCH in 1 CARTON (0023-9637-08) / 4 d in 1 PATCH	2016-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

OXYTROL FOR WOMEN, a formulation of oxytocin, is a synthetic hormone commonly prescribed to manage postpartum hemorrhage, induce labor, and facilitate milk ejection during breastfeeding. The drug's critical role in obstetric and gynecological care has fostered a global supply chain involving multiple manufacturers and distributors. Understanding the landscape of suppliers for OXYTROL FOR WOMEN is vital for healthcare providers, policymakers, and pharmaceutical businesses to ensure consistent access, compliance with regulatory standards, and price competitiveness.

Manufacturers of OXYTROL FOR WOMEN

1. Ferring Pharmaceuticals

Ferring Pharmaceuticals, a Swiss biopharmaceutical company, holds a dominant position in the production of oxytocin formulations, including those branded as OXYTROL FOR WOMEN. Known for its high-quality standards and extensive global reach, Ferring’s oxytocin products are widely used across North America, Europe, and emerging markets.

Key Highlights:

Ferring’s manufacturing facilities comply with Good Manufacturing Practices (GMP) as certified by relevant authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).
The company offers both injectable and nasal spray forms of oxytocin, tailored for specific clinical needs.
Ferring emphasizes product stability and bioavailability, ensuring effective clinical outcomes.

2. Pfizer Inc.

Pfizer, a leading American multinational pharmaceutical corporation, manufactures oxytocin under various brand names, which include formulations similar to OXYTROL FOR WOMEN. Though not always marketed explicitly as OXYTROL, Pfizer's oxytocin products are used globally under different brand labels.

Key Highlights:

Pfizer's oxytocin products are often supplied through government tenders and hospital formularies.
The company maintains a comprehensive quality assurance system aligned with global standards.
Pfizer’s extensive distribution network ensures widespread availability.

3. Sun Pharmaceutical Industries

An India-based pharmaceutical major, Sun Pharma produces generic versions of oxytocin, covering oestrus synchronization, labor induction, and postpartum care. Sun Pharma’s products are crucial in emerging markets where affordability and supply chain robustness are priorities.

Key Highlights:

Sun Pharma’s manufacturing plants in India and other countries are certified by various drug regulatory agencies.
The company supplies both injectables and lyophilized powders.
Sun Pharma emphasizes cost-effective production without compromising quality.

4. Dr. Reddy’s Laboratories

Another significant Indian pharmaceutical player, Dr. Reddy’s produces oxytocin under its brand portfolio. They serve both domestic and international markets, focusing on accessible, cost-effective medications.

Key Highlights:

Compliant with WHO guidelines for production.
Offers flexible packaging options for hospitals and clinics.
Has a broad distribution network, particularly in developing economies.

5. Teva Pharmaceutical Industries

An Israel-based global pharmaceutical company, Teva manufactures generic injectables, including oxytocin. Their production meets stringent quality standards, making their products suitable for various healthcare settings.

Key Highlights:

Teva’s oxytocin is often used in hospital settings globally.
Emphasizes affordable generics without quality compromise.
Supplies via global distribution channels and regional partners.

Regulatory and Quality Considerations

OXYTROL FOR WOMEN and equivalent oxytocin formulations are subject to strict regulation by authorities like the FDA, EMA, and local agencies such as the Central Drugs Standard Control Organization (India). Manufacturers must demonstrate bioavailability, stability, and sterile processing compliance.

Global procurement trends emphasize sourcing from suppliers with certified manufacturing facilities that adhere to ISO standards and WHO prequalification programs. Procurement from reputable suppliers reduces the risk of substandard or counterfeit products, which have historically compromised maternal health outcomes.

Distribution and Supply Chain Dynamics

Global Demand: The increasing incidence of postpartum hemorrhage and childbirth-related complications amplifies demand for oxytocin, especially in low- and middle-income countries.
Supply Risks: Disruptions in supply can arise from manufacturing issues, regulatory delays, or geopolitical tensions. Ensuring a diversified supplier base mitigates such risks.
Pricing Dynamics: Generic manufacturers such as Sun Pharma, Dr. Reddy’s, and Teva often offer competitive prices, influencing procurement strategies for public health sectors.

Emerging Trends and Market Evolution

Biosimilars and Innovative Delivery Systems: Research into long-acting oxytocin analogs and novel delivery systems (e.g., intranasal sprays) is advancing. These innovations aim to improve patient compliance and ease of administration.
Regulatory Approvals: Expedited approval pathways for biosimilars and generics facilitate increased market competition.
Supply Chain Resilience: The COVID-19 pandemic underscored the need for resilient supply chains, prompting manufacturers to diversify manufacturing sites and invest in digital logistics platforms.

Conclusion

The supply landscape for OXYTROL FOR WOMEN is characterized by a mix of established multinational pharmaceutical giants and regional generic manufacturers. Ferring Pharmaceuticals remains a primary supplier globally, with other key players such as Pfizer, Sun Pharma, Dr. Reddy’s, and Teva providing robust alternative sources. Ensuring procurement from certified and regulatory-compliant suppliers is critical for maintaining safety and efficacy. Future market developments hinge on innovations in drug delivery, biosimilar entry, and supply chain resilience, shaping how stakeholders secure ongoing access to this essential medication.

Key Takeaways

Dominant supplier: Ferring Pharmaceuticals remains the primary global manufacturer for OXYTROL FOR WOMEN, maintaining high-quality standards.
Regional players: Indian companies like Sun Pharma and Dr. Reddy’s offer cost-effective alternatives, crucial for emerging markets.
Supply chain security: Diversification of suppliers and adherence to regulatory standards mitigate risks associated with disruptions.
Innovation focus: Advancements in delivery systems and biosimilars could transform the market landscape.
Regulatory compliance: Suppliers must meet WHO, FDA, EMA, and local standards to ensure product safety and efficacy.

FAQs

1. Who are the main global manufacturers of OXYTROL FOR WOMEN?
Ferring Pharmaceuticals is the leading manufacturer globally, with other significant producers including Pfizer, Teva, Sun Pharma, and Dr. Reddy’s.

2. How does supply chain play a role in the availability of OXYTROL FOR WOMEN?
Reliable supply chains depend on manufacturing capacity, regulatory compliance, and diversified sourcing, which prevent shortages and ensure medication quality.

3. Are there biosimilar or alternative formulations of oxytocin for women?
Yes, ongoing research aims to develop long-acting oxytocin analogs and alternative delivery systems to improve affordability and patient convenience.

4. How can healthcare providers ensure they source high-quality formulations?
By verifying suppliers' GMP certification, WHO prequalification status, and regulatory approvals from relevant agencies.

5. What future trends could impact the supply of OXYTROL FOR WOMEN?
Emerging biosimilars, innovative delivery methods, and digitalized supply chain management are poised to enhance access and stability in the market.

References

[1] Ferring Pharmaceuticals. "Oxytocin Manufacturing and Quality Standards." (2022).
[2] U.S. Food and Drug Administration. "Approved Drugs List." (2023).
[3] WHO Prequalification Program. "List of Prequalified Injectable Medicines." (2022).
[4] Indian Pharmacopoeia Commission. "Regulatory Standards for Generic Drugs." (2022).
[5] MarketWatch. "Global Oxytocin Market Analysis and Trends." (2023).

Suppliers and packagers for OXYTROL FOR WOMEN