Suppliers and packagers for PROMETHEGAN

PROMETHEGAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	PROMETHEGAN	promethazine hydrochloride	SUPPOSITORY;RECTAL	087165	ANDA	Cosette Pharmaceuticals, Inc.	0713-0132-10	1000 SUPPOSITORY in 1 BOX (0713-0132-10)	1987-08-31
Cosette	PROMETHEGAN	promethazine hydrochloride	SUPPOSITORY;RECTAL	087165	ANDA	Cosette Pharmaceuticals, Inc.	0713-0132-12	12 SUPPOSITORY in 1 BOX (0713-0132-12)	1987-08-31

Suppliers for the Pharmaceutical Drug: Promethegan

Last updated: August 8, 2025

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Introduction

Promethegan, an established pharmaceutical product, is primarily known by its generic name, prochlorperazine. It is widely utilized for the treatment of nausea, vomiting, and vertigo, functioning as a potent phenothiazine derivative with anxiolytic and antipsychotic properties. Given its therapeutic significance, the global supply chain and sourcing of prochlorperazine are critical for healthcare providers and pharmaceutical companies. This article explores the key suppliers manufacturing Promethegan, delving into their market presence, manufacturing capabilities, regulatory adherence, and supply chain robustness.

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Overview of Promethegan and Its Active Ingredient: Prochlorperazine

Prochlorperazine is a first-generation antipsychotic agent classified under phenothiazines. Its widespread prescription for antiemetic and antipsychotic indications necessitates a reliable supply of high-quality active pharmaceutical ingredients (APIs). Promethegan, as a branded or generic form, utilizes prochlorperazine dihydrochloride as the core API. The manufacturing and distribution of this API are tightly regulated, with suppliers required to meet strict standards set by authorities such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other global regulatory bodies.

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Major Suppliers of Prochlorperazine (Promethegan)

1. Teva Pharmaceutical Industries Ltd.

Overview:
Teva is a leading global manufacturer of generic medicines, including prochlorperazine. Known for extensive API manufacturing capabilities, Teva supplies numerous hospitals and pharmaceutical companies worldwide.

Manufacturing Capabilities:
Teva's API facilities in Israel and Europe are FDA-, EMA-, and GMP-compliant, ensuring high-quality production. Their formulations division also produces Promethegan or equivalent generics.

Market Presence:
Teva's strong distribution networks across North America, Europe, and Asia make it a primary supplier for prochlorperazine, and by extension, Promethegan.

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2. Mylan N.V. (Now part of Viatris)

Overview:
Viatris, formed from Mylan and Pfizer’s Upjohn division, maintains significant API production facilities worldwide. Mylan's historic strengths in producing phenothiazines position it as a key supplier.

Manufacturing Capabilities:
Mylan's manufacturing assets in India, the UK, and the US produce prochlorperazine API under stringent quality controls. These APIs are often supplied directly to generic drug manufacturers.

Supply Chain Strategy:
Viatris emphasizes supply chain diversification, mitigating risks associated with geopolitical issues or regulatory changes affecting API production.

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3. Novartis AG

Overview:
Primarily recognized for proprietary pharmaceuticals, Novartis also manufactures APIs, including phenothiazines, for internal use or external licensing.

Manufacturing Capabilities:
While not a dominant supplier of prochlorperazine, Novartis’s high-quality API production capacity makes it a potential secondary supplier, especially for premium formulations.

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4. Sinopharm Chemical Reagent Co., Ltd.

Overview:
A major Chinese API producer, Sinopharm supplies a broad portfolio of pharmaceuticals, including phenothiazine derivatives like prochlorperazine.

Regulatory Status:
Chinese GMP standards are increasingly aligning with international standards, providing assurance for global supply needs, though regulatory approval is required in specific countries.

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5. Other Notable Suppliers

• Alpham Resources Co., Ltd. (India)
• Hunan Dongting Pharmaceutical Co., Ltd. (China)
• Kyorin Pharmaceutical Co., Ltd. (Japan)

These organizations produce prochlorperazine APIs mainly for regional markets but are increasingly expanding into global supply channels.

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Supply Chain and Regulatory Considerations

Regulatory Compliance:
Suppliers must adhere to GMP standards recognized internationally. Any deviation can impact the supply chain, leading to shortages or regulatory sanctions.

Quality Assurance:
Due to the critical nature of Promethegan, pharmaceutical companies prioritize suppliers with robust quality control systems, including batch testing, stability studies, and purity assessments.

Supply Chain Risks:
Concentration of API manufacturing in regions like China and India presents geopolitical and logistical risks. Diversification strategies involve engaging multiple suppliers across different geographies.

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Emerging Trends in Supplier Selection

• API Sourcing Diversification: To prevent disruptions, companies are expanding sourcing from multiple suppliers.
• Vertical Integration: Larger pharmaceutical firms are investing in API manufacturing facilities to control quality and supply.
• Regulatory Harmonization: Suppliers investing in obtaining approvals from multiple health authorities to expand market access.

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Conclusion

The supply landscape for Promethegan hinges on a handful of key API manufacturers with global footprints, notably Teva, Viatris (Mylan), and Chinese producers like Sinopharm. Ensuring a continuous, high-quality supply requires navigating complex regulatory environments, maintaining supply chain resilience, and fostering strategic supplier relationships. As the global pharmaceutical industry evolves, diversification and stringent quality controls will remain pivotal for consistent Promethegan availability.

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Key Takeaways

• Promethegan’s active ingredient, prochlorperazine, is primarily supplied by global generic API manufacturers like Teva and Viatris.
• API manufacturing is concentrated in regions with strict GMP standards, notably North America, Europe, and parts of Asia.
• Supply chain resilience depends on diversification across geographies and continuous regulatory compliance.
• High-quality API suppliers are critical to maintaining product integrity, regulatory approval, and uninterrupted patient access.
• Industry trends favor strategic diversification, vertical integration, and regulatory harmonization to mitigate supply risks.

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FAQs

1. Who are the leading global suppliers of prochlorperazine?
Teva and Viatris are among the predominant suppliers of prochlorperazine API globally, complemented by regional manufacturers in China and India.

2. What regulatory standards must API suppliers meet for Promethegan?
Suppliers must adhere to GMP standards recognized by authorities such as the FDA, EMA, and other regional agencies to ensure safety, efficacy, and quality.

3. How do supply chain disruptions affect Promethegan availability?
Disruptions in API production or geopolitical issues can lead to shortages, impacting manufacturing and availability in key markets.

4. Are new suppliers emerging in the prochlorperazine market?
Yes, several emerging suppliers from Asia are increasing their capacity, offering potential for supply diversification.

5. What is the future outlook for Promethegan API supply?
The market is expected to see ongoing diversification, regulatory harmonization, and investments in manufacturing capacity to ensure reliable supplies amid growing global demand.

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Sources

1. [1] Teva Pharmaceutical Industries Ltd. Corporate Website.
2. [2] Viatris Inc. Corporate Profile.
3. [3] Novartis AG API Manufacturing Capabilities.
4. [4] Sinopharm Chemical Reagent Co., Ltd. Official Website.
5. [5] Industry Reports on API Supply Chain Resilience.