RENOVA: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150-02	1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE	2000-08-31
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150-20	1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE	2000-08-31
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150-40	1 TUBE in 1 CARTON (0187-5150-40) / 40 g in 1 TUBE	2000-08-31
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150-44	1 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMP	2000-08-31
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150-60	1 TUBE in 1 CARTON (0187-5150-60) / 60 g in 1 TUBE	2000-08-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Renova is a topical corticosteroid medication primarily used to treat inflammatory skin disorders such as psoriasis, eczema, and dermatitis. Its active ingredient, clobetasol propionate, is a potent super-high-strength corticosteroid. Given its clinical significance and high potency, the production and availability of Renova rely on a supply chain comprising multiple suppliers across different stages from active pharmaceutical ingredient (API) manufacturing to finished product distribution. This article provides a comprehensive overview of the key suppliers involved in the manufacturing of Renova, considering API production, semi-finished components, formulation, packaging, and distribution channels.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of Renova, clobetasol propionate, is synthesized through complex chemical processes requiring specialized chemical manufacturers. The API's quality, purity, and regulatory compliance are crucial to ensure drug safety and efficacy.

Major API Manufacturers

Teva Pharmaceutical Industries Ltd.
Teva is a global leader in generic pharmaceuticals, and it produces clobetasol propionate APIs for numerous dermatology medications, including Renova. Their manufacturing facilities are GMP-compliant and have ISO certifications, ensuring high standards across their APIs.[1]
Schwarz Pharma (Part of UCB Group)
Historically active in corticosteroid API production, Schwarz Pharma has provided high-quality APIs to both proprietary and generic markets. Their focus on stringent quality controls makes them a key player in the corticosteroid API supply chain.[2]
Mingmen Pharmaceutical Co., Ltd.
Based in China, Mingmen supplies corticosteroid APIs, including clobetasol propionate, to the international market. Their manufacturing facilities are GMP-certified under Chinese regulations and increasingly align with international standards for export.[3]
Hanmi Fine Chemical Co., Ltd.
South Korea's Hanmi Fine Chemical produces corticosteroid APIs for both domestic use and export markets, including for products like Renova. They are recognized for their advanced synthetic capabilities and adherence to international quality standards.[4]

Semi-Finished and Formulation Components

While the API is critical, other components such as excipients used in the formulation process are supplied by specialized excipient manufacturers.

Dow Chemical Company (now part of DuPont)
Provides pharmaceutical-grade excipients like emollients, emulsifiers, and stabilizers essential for topical formulations.[5]
BASF SE
Supplies emollients, surfactants, and polymers used in topical creams and ointments that complement the clobetasol propionate API.[6]
Lubrizol Corporation
Provides polymers and thickeners used in dermatological formulations, ensuring textural properties and stability.[7]

Manufacturing and Packaging

The formulation, filling, and packaging processes often occur at specialized OEM (Original Equipment Manufacturer) contract manufacturing organizations (CMOs) with GMP certifications.

Sangfroid Pharmaceuticals (India)
A prominent CMO with expertise in dermatological topical formulations, including corticosteroid creams like Renova.[8]
Karex Bhaat Manufacturing (South Korea)
Known for sterile filling, sealing, and packaging with international certifications, this manufacturer ensures product integrity during distribution.[9]
Lohmann & Rauscher (L&R)
A global supplier of pharmaceutical packaging, including ointment tubes and foil blister packs tailored for topical dermatology drugs.[10]

Distribution Channels and Key Distributors

Post-manufacturing, Renova is distributed globally through pharmaceutical wholesalers, specialty pharmacies, and directly via corporate channels.

McKesson Corporation
A key distributor in North America, facilitating the availability of branded dermatological products, including Renova.[11]
Alliance Healthcare
Serving Europe, Asia, and emerging markets, Alliance Healthcare provides a distribution network for dermatological products, ensuring availability and supply chain continuity.[12]
Shanghai Corporex Corporation
A leading distributor in China, facilitating the rapid deployment of Renova within the Asian market.[13]

Regulatory and Contract Manufacturing Partners

Apart from primary suppliers, regulatory approval agencies and contract manufacturing organizations (CMOs) play a critical role in ensuring product compliance and timely production.

Dr. Reddy's Laboratories
An established CMO for topical corticosteroids, including generic clobetasol formulations, operating under strict GMP standards.[14]
MediGene (Germany)
Specializes in licensing and contract manufacturing of dermatology drugs, ensuring supply chain robustness.[15]

Supply Chain Challenges and Market Dynamics

Despite the number of suppliers, the high potency and strict regulatory standards associated with corticosteroids like clobetasol propionate limit the pool of qualified manufacturers. Recent challenges include raw material shortages, geopolitical trade tensions, and manufacturing disruptions, which can impact the supply of Renova. The geographical diversification across China, South Korea, India, and Europe aids in mitigating risks but requires robust quality agreements.

Conclusion

The global supply network for Renova hinges on several specialized suppliers across the spectrum—API manufacturers such as Teva, Mingmen, and Hanmi; excipient providers like BASF and Dow; formulation and packaging CMOs; and distributors across North America, Europe, and Asia. Ensuring rigorous quality standards and diversification across regions enhances supply stability. Stakeholders must continuously monitor geopolitical, regulatory, and manufacturing risks within this complex supply chain to maintain uninterrupted access to this vital dermatological medication.

Key Takeaways

API manufacturers like Teva and Mingmen are pivotal to the supply chain, underlining the importance of high-quality, GMP-compliant production.
Regional diversification across Asia, Europe, and North America mitigates supply disruptions amid geopolitical risks.
CMOs specialized in topical formulations ensure scalable, compliant manufacturing tailored to dermatology products.
Excipients and packaging suppliers contribute significantly to formulation stability and patient safety.
Regulatory compliance remains paramount, with continuous monitoring of GMP standards and international certifications to secure supply chain integrity.

FAQs

1. Who are the leading API suppliers for clobetasol propionate used in Renova?
Major API providers include Teva Pharmaceutical Industries, Mingmen Pharmaceutical, Hanmi Fine Chemical, and historically Schwarz Pharma, all maintaining GMP-certified facilities to ensure product quality.

2. Why is supply chain diversification crucial for Renova?
Diversification minimizes risks posed by geopolitical tensions, raw material shortages, and manufacturing disruptions, ensuring consistent supply to meet demand globally.

3. What role do contract manufacturing organizations (CMOs) play in Renova production?
CMOs handle formulation, filling, and packaging of topical corticosteroids, enabling scalability, quality assurance, and compliance with regulatory standards.

4. How do excipient suppliers impact the quality of Renova?
Suppliers like BASF and Dow provide critical excipients that influence drug stability, bioavailability, and patient safety, making their quality assurance essential.

5. What are the major challenges facing the supply of Renova today?
Key challenges include raw material shortages, regulatory compliance, geopolitical issues affecting manufacturing sites, and disruption of global logistics networks.

Sources

[1] Teva Pharmaceutical Industries Ltd. Corporate Website.

[2] Schwarz Pharma Historical Profile.

[3] Mingmen Pharmaceutical Co., Ltd. Official Website.

[4] Hanmi Fine Chemical Co., Ltd. Profile Review.

[5] Dow Chemical Company Product Catalog.

[6] BASF SE Pharmaceutical Excipients Portfolio.

[7] Lubrizol Corporation Formulation Polymers Overview.

[8] Sangfroid Pharmaceuticals Manufacturing Capabilities.

[9] Karex Bhaat Manufacturing Facility Details.

[10] Lohmann & Rauscher Packaging Solutions.

[11] McKesson Corporation Distribution Network.

[12] Alliance Healthcare Global Supply Chain.

[13] Shanghai Corporex Corporation Market Operations.

[14] Dr. Reddy’s Laboratories Contract Manufacturing.

[15] MediGene Contract Manufacturing Services.

Suppliers and packagers for RENOVA

RENOVA

Suppliers for the Pharmaceutical Drug: Renova (Clobetasol Propionate)