Suppliers and packagers for pramosone

pramosone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-144-64	1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE	2010-04-13
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-03	57 g in 1 TUBE (54766-716-03)	2015-08-04
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-04	28.4 g in 1 TUBE (54766-716-04)	2015-08-04
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-778-04	28.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04)	2015-08-05

Suppliers for the Pharmaceutical Drug: PRAMOSONE

Last updated: July 28, 2025

Introduction

PRAMOSONE is a pharmaceutical formulation primarily known for its corticosteroid activity, often used in dermatology for anti-inflammatory and immunosuppressive purposes. Its generic form contains betamethasone dipropionate and gentamicin sulfate, combining anti-inflammatory with antibacterial properties. The stability and efficacy of PRAMOSONE make it sought after by healthcare providers globally. This article reviews key suppliers, manufacturing regions, and supply chain considerations for PRAMOSONE, providing critical insights for stakeholders involved in procurement, distribution, and regulatory compliance.

Understanding PRAMOSONE Composition and Usage

PRAMOSONE typically exists as a topical ointment or cream, formulated to treat inflammatory skin conditions contaminated or at risk of bacterial infection. The primary active ingredients, corticosteroids, and antibiotics—betamethasone dipropionate and gentamicin—are well-established drugs with extensive manufacturing histories.

The global demand for PRAMOSONE hinges significantly on conditions such as eczema, psoriasis, dermatitis, and infected skin lesions. Given its combination of efficacy and affordability, it remains a popular choice among physicians in various healthcare systems.

Leading Manufacturers and Suppliers for PRAMOSONE

1. Indian Pharmaceutical Companies

India remains a dominant hub for manufacturing and supplying generic corticosteroid-antibiotic combinations like PRAMOSONE.

• Mankind Pharma: Mankind is a prominent pharmaceutical company that manufactures and markets PRAMOSONE under various brand names. Their robust API (Active Pharmaceutical Ingredient) manufacturing and finished product capabilities ensure consistent supply chains. Mankind’s extensive distribution network spans India and exports to over 70 countries, making them a crucial supplier globally.

• Aventis Pharma (Sanofi): Though primarily known for branded pharmaceuticals, their Indian manufacturing units produce PRAMOSONE formulations, especially for domestic use. Collaborations with local distributors facilitate wide availability.

• Cipla Limited: Renowned for its extensive portfolio, Cipla manufactures corticosteroid-based formulations, including PRAMOSONE, targeting both domestic and international markets. Their vertical integration ensures reliable supply.

• Ipsen Pharmaceuticals: Specialized in dermatology products, Ipsen supplies PRAMOSONE formulations for select markets, leveraging regional manufacturing facilities.

2. Chinese Pharmaceutical Manufacturers

China’s pharmaceutical industry has expanded considerably, offering both APIs and finished formulations for corticosteroid combinations.

• Shanghai Saibo Pharmaceutical Co., Ltd.: Produces generic corticosteroid-antibiotic products, including PRAMOSONE equivalents, targeting Asia and emerging markets.

• Shandong Xinhua Pharmaceutical: An API manufacturer contributing to the supply of betamethasone and gentamicin, supporting formulators globally.

3. European and US-Based Suppliers

While primary manufacturers of PRAMOSONE formulations are predominantly in Asia, some European and US-based firms supply generic APIs and may facilitate licensed production.

• Fresenius Kabi: Offers APIs and formulations, ensuring high manufacturing standards and compliance with international regulations like GMP (Good Manufacturing Practice).

• Sigma-Aldrich (now part of Merck): Supplies chemicals and APIs, including corticosteroids and aminoglycosides, to approved pharmaceutical manufacturers.

Supply Chain Dynamics and Regional Variances

1. API Manufacturing and Export Hubs

APIs for PRAMOSONE, such as betamethasone dipropionate and gentamicin sulfate, are primarily produced in India, China, and some European countries. The extensive API manufacturing capacity in India ensures cost-effective production, supporting both domestic and international formulations.

2. Formulation Production

Finished formulations—creams and ointments—are predominantly assembled in India, China, and some European facilities. The capability for large batch production while adhering to quality standards enables continuous supply for global markets.

3. Regulatory Considerations

Suppliers must comply with international quality standards, including US FDA, EMA, and WHO-GMP certifications, to access regional markets. Regulatory delays or non-compliance can impact supply stability.

4. Distribution and Logistics

For procurement professionals, understanding regional distribution channels is critical. Indian and Chinese manufacturers often collaborate with regional distributors, ensuring timely delivery, especially in developing countries.

Market Trends and Future Outlook

The demand for PRAMOSONE is expected to grow, driven by the prevalence of skin conditions and increased healthcare access in emerging markets. The rise of biosimilar and generic manufacturers in Asia enhances supply resilience. Additionally, the ongoing trend of consolidations and licensing agreements between manufacturers could influence supplier dynamics.

Risks and Challenges in PRAMOSONE Supply

• Regulatory Delays: Varying approval timelines across countries can interrupt supply flows.
• Quality Variability: Differing manufacturing standards may lead to inconsistent product quality.
• Intellectual Property (IP): Although PRAMOSONE formulations are often generic, patent expirations and licensing agreements can influence supplier options.
• Price Fluctuations: Raw material costs for APIs influence final product prices and supply margins.

Key Factors for Stakeholders

• Ensure suppliers possess WHO-GMP, US FDA, or EMA certifications to guarantee quality.
• Develop relationships with multiple manufacturers to mitigate supply disruptions.
• Stay abreast of regulatory changes impacting import/export of PRAMOSONE formulations.

Conclusion

The global supply of PRAMOSONE relies heavily on key Asian manufacturers, primarily in India and China, supported by regulatory bodies ensuring quality standards. While Indian pharmaceutical firms (e.g., Mankind Pharma, Cipla) dominate the finished formulation landscape, API supply chains are diversified across China and India. Future growth hinges on scalable manufacturing, regulatory harmonization, and supply chain resilience, essential considerations for stakeholders seeking reliable sources of PRAMOSONE.

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Key Takeaways

• Major Suppliers: Indian firms like Mankind Pharma, Cipla, and local Chinese API manufacturers are primary suppliers of PRAMOSONE formulations and APIs.
• Regulatory Compliance: Suppliers with international GMP certifications ensure market access and product quality.
• Supply Chain Resilience: Diversify sourcing and maintain relationships with multiple suppliers across regions to mitigate disruptions.
• Market Growth: Rising dermatological conditions and expanding healthcare access support increasing demand in emerging markets.
• Strategic Procurement: Leverage regional expertise and regulatory knowledge for efficient sourcing of PRAMOSONE.

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FAQs

1. Are there generic equivalents of PRAMOSONE available globally?
Yes, numerous generic formulations containing betamethasone dipropionate and gentamicin sulfate are available, primarily manufactured in India and China. These generics often comply with regional regulatory standards, offering equivalent efficacy.

2. What are the primary considerations when sourcing PRAMOSONE?
Quality assurance through GMP certification, reliable supply chains, regulatory compliance, and cost-effectiveness are key procurement considerations.

3. How has the COVID-19 pandemic affected PRAMOSONE supply chains?
The pandemic caused temporary disruptions due to manufacturing delays, logistical bottlenecks, and regulatory scrutiny, emphasizing the need for diversified sourcing and strategic stockpiling.

4. Which regions are the largest markets for PRAMOSONE formulations?
India, Southeast Asia, Africa, and parts of Latin America represent significant markets, driven by affordability and high prevalence of skin conditions.

5. Is the regulatory landscape for importing PRAMOSONE complex?
It varies by country; compliance with local drug approval agencies like the FDA, EMA, or regional health authorities is necessary, often requiring documentation of manufacturing standards and batch testing.

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Sources

1. [1] Indian Pharmaceutical Industry Report, Department of Pharmaceuticals, Government of India, 2022.
2. [2] Chinese Pharmaceutical Regulatory Review, Chinese National Medical Products Administration, 2022.
3. [3] WHO-GMP Certification Database, World Health Organization, 2023.
4. [4] Global API Market Outlook, IQVIA, 2022.
5. [5] Regulatory Guidelines for Topical Corticosteroids and Antibiotics, FDA and EMA, 2022.