misoprostol: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201	ANDA	GenBioPro, Inc.	43393-024-04	4 TABLET in 1 BOTTLE (43393-024-04)	2024-09-30
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201	ANDA	GenBioPro, Inc.	43393-200-48	12 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK (43393-200-04)	2024-09-30
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201	ANDA	GenBioPro, Inc.	43393-200-60	60 TABLET in 1 BOTTLE (43393-200-60)	2024-09-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Misoprostol, a prostaglandin E1 analog, serves multiple medical purposes, including the prevention of gastric ulcers, induction of labor, and facilitation of abortion. Due to its diverse applications, misoprostol's global procurement involves a broad network of suppliers spanning reputable pharmaceutical companies, generic manufacturers, and chemical intermediates providers. This article provides an in-depth overview of the key suppliers, their market dynamics, regulatory considerations, and the implications for stakeholders in the pharmaceutical supply chain.

Market Overview of Misoprostol Suppliers

Misoprostol is marketed under various brand names worldwide, notably Cytotec (by Pfizer) and generic formulations available through multiple manufacturers. Despite Pfizer's historical role as a pioneering supplier, the current landscape is characterized by a proliferation of generic producers, especially in regions with robust pharmaceutical manufacturing capabilities, such as India, China, and Latin America.

Major Pharmaceutical Companies Supplying Misoprostol

1. Pfizer Inc.

Pfizer's Cytotec historically represented the original formulation of misoprostol, approved initially for gastric ulcer prevention. Although Pfizer has scaled back its direct marketing of Cytotec in some regions, it remains a significant supplier in certain markets. Pfizer's production standards are aligned with stringent regulatory frameworks, ensuring high-quality standards (GMP-certified). However, in many developing countries, Pfizer's role has diminished as generic manufacturers have entered the market.

2. Indian Pharmaceutical Manufacturers

India emerges as a dominant player, accounting for a significant share of the global misoprostol supply. Several reputable companies produce both branded and generic misoprostol, often supplying to international markets:

Sun Pharmaceutical Industries Ltd.: One of India’s largest pharmaceutical exporters, Sun Pharma manufactures misoprostol in compliance with WHO GMP standards and supplies globally, especially to underserved markets.
Hetero Labs Ltd.: Hetero is a major API (Active Pharmaceutical Ingredient) producer for misoprostol, providing APIs to generic companies worldwide.
Glenmark Pharmaceuticals: Glenmark manufactures misoprostol tablets and API, with a focus on quality and affordability.
Cadila Healthcare (Zydus Cadila): Zydus produces misoprostol for both domestic and export markets, adhering to regional regulatory standards.

3. Chinese Manufacturers

China hosts a dense network of API producers and finished formulation manufacturers:

North China Pharmaceutical Group (NCPC): Active in the API space, supplying misoprostol intermediates and APIs for global markets.
Shandong Xinhua Pharmaceutical Co., Ltd.: Enters the value chain as both API producer and finished dosage manufacturer, often supplying to generic markets.
These Chinese companies primarily produce raw APIs, which are then supplied to downstream formulators worldwide.

4. Other Regional Suppliers

Egyptian and Brazilian generic manufacturers like Eczacibasi and Biotoscana are also notable suppliers, primarily serving their respective regions.

Regulatory and Quality Considerations

Suppliers’ credibility hinges on compliance with quality standards mandated by authorities such as the US FDA, EMA, TGA, and regional counterparts like WHO prequalification programs. While many Indian and Chinese manufacturers adhere to GMP, discrepancies in regulatory oversight can impact the quality and safety of supply. Due diligence is essential for procurement, emphasizing certifications, batch testing, and supplier audits.

Supply Chain Challenges and Risks

Patent Status and Generic Competition: Since misoprostol’s patent expired decades ago, generic proliferation has compressed prices and diversified suppliers, though market access varies due to regulatory hurdles.
Regulatory Restrictions: Some countries impose stringent import controls or bans on misoprostol owing to its use in self-managed abortions, affecting supply availability.
Quality Assurance: Variability among suppliers underscores the need for rigorous quality assurance, including independent testing and certification to prevent substandard products entering the supply chain.
Geopolitical Dynamics: Political tensions can influence trade flows, especially concerning Chinese and Indian manufacturers, impacting global procurement strategies.

Market Trends and Future Outlook

Global demand for misoprostol, especially driven by reproductive health initiatives, continues to grow. Generic manufacturers are expanding capacity to meet increased needs, with some firms investing in API synthesis and formulation capabilities. Efforts towards regulatory harmonization aim to streamline procurement and quality assurance.

Moreover, increasing advocacy for reproductive rights and legalization of medical abortion in various jurisdictions heightens demand for reliable suppliers. The trend toward lower-cost generics enhances access but emphasizes the importance of world-class quality standards.

Conclusion

In the evolving landscape of global pharmaceutical supply, multiple suppliers provide misoprostol, predominantly from India and China, supplemented by regional manufacturers. Stakeholders must prioritize supplier due diligence, regulatory compliance, and quality assurance to ensure a secure, safe, and effective supply chain. The increasing demand underscores the importance of fostering transparent, regulated markets that uphold high standards.

Key Takeaways

The global misoprostol supply predominantly originates from Indian and Chinese manufacturers, with Pfizer’s role diminishing in some regions.
Quality assurance and regulatory compliance remain critical, especially given the variability among low-cost generic suppliers.
Political and regulatory factors influence supply stability, necessitating diversified sourcing strategies.
Increasing demand driven by reproductive health initiatives points to sustained growth and the need for reliable suppliers.
Strategic partnerships with WHO-prequalified manufacturers can mitigate risks associated with substandard products.

FAQs

1. Are all suppliers of misoprostol equally reliable in terms of quality?
No. Variability exists among manufacturers, especially between those with WHO prequalification and those without. Due diligence, including audits and certification verification, is essential to ensure quality.

2. Can misoprostol be purchased directly from Chinese or Indian manufacturers?
Typically, procurement involves intermediaries or distributors adhering to regional regulations. Direct purchasing is possible but requires compliance with import laws, quality verification, and often, registration with regulatory agencies.

3. How does patent status influence the supply of misoprostol?
Misoprostol's patent expired in the 1980s, paving the way for generic production and increasing supplier diversity. This enhances availability but also necessitates rigorous quality control measures.

4. What role does WHO prequalification play in misoprostol supply?
WHO prequalification certifies that suppliers’ products meet international standards for quality, efficacy, and safety, serving as a benchmark for procurement agencies and governments.

5. Is misoprostol supply affected by regulatory restrictions on abortion?
Yes. Some countries restrict access or impose regulatory hurdles on misoprostol, impacting its availability for medical abortion, although supply for other indications like gastric ulcers remains unaffected in many regions.

References

[1] WHO. (2021). Medical management of abortion. WHO Guidelines.
[2] U.S. Food and Drug Administration. (2022). Cytotec (Misoprostol) labeling.
[3] European Medicines Agency. (2020). Pharmacovigilance and Quality Standards for Misoprostol.
[4] Indian Pharmaceutical Industry Reports. (2022). Market Analysis and Global Export Data.
[5] Chinese Pharmaceutical Regulatory Frameworks. (2021). API Manufacturing Standards and Export Regulations.

Suppliers and packagers for misoprostol

misoprostol

Suppliers for the Pharmaceutical Drug: Misoprostol