Suppliers and packagers for clindagel

clindagel

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782	NDA	Bausch Health US, LLC	16781-462-06	6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE	2013-11-25
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782	NDA	Bausch Health US, LLC	16781-462-75	1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE	2013-11-25
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-462-75	1 BOTTLE in 1 CARTON (68682-462-75) / 75 mL in 1 BOTTLE	2018-06-08

Suppliers for the Pharmaceutical Drug: Clindagel

Last updated: August 2, 2025

Introduction

Clindagel, a topical formulation of clindamycin phosphate, is widely prescribed for the treatment of moderate to severe acne vulgaris. Its efficacy stems from its ability to inhibit bacterial protein synthesis, effectively reducing Propionibacterium acnes populations on the skin. As a critical dermatological medication, understanding the supply landscape for Clindagel and its equivalents is crucial for stakeholders across healthcare, manufacturing, and distribution sectors. This report examines the primary suppliers, manufacturing sources, and market dynamics shaping Clindagel’s availability globally.

Manufacturers of Clindagel

Clindagel, with its active pharmaceutical ingredient (API) clindamycin phosphate, is primarily produced by major pharmaceutical companies. The original formulation was developed and marketed by pharmaceutical industry leaders, and several generic manufacturers now produce equivalent formulations. Notably:

• AbbVie (formerly part of Abbott Laboratories): As the original patent holder until patent expiration, they marketed Clindagel. Although the patent has expired, AbbVie continues to have manufacturing capabilities and may supply original products through various channels, depending on regional policies.

• Generic Manufacturers: Post-patent expiry, numerous generic manufacturers have entered the market. These include entities in both established pharma manufacturing centers and emerging markets, ensuring a broader supply chain diversity.

Key Suppliers and Distributors Globally

1. Ind-Swift Laboratories Ltd. (India): One of the prominent global suppliers, Ind-Swift manufactures generic clindamycin topical formulations, including gels similar or identical to Clindagel. They export to multiple regions, including North America, Europe, and Asia.

2. Sun Pharmaceutical Industries Ltd. (India): A leading generic manufacturer with a portfolio that includes clindamycin topical formulations, Sun Pharma supplies to various international markets, often at competitive prices.

3. Pfizer Inc.: Although mainly known for oral clindamycin, Pfizer has been involved in dermatological formulations and may serve as a supplier through licensing agreements or regional distribution.

4. Laurus Labs (India): An emerging supplier with a growing portfolio of topical antibiotics, including clindamycin-based products.

5. Siegfried AG (Germany): Specializes in sterile and semi-solid formulations, including topical antibiotics, serving as an OEM and supplier in European markets.

6. Local and Regional Distributors: In addition to large manufacturers, regional distributors and compounding pharmacies supply Clindagel or equivalent formulations to local markets, especially in areas with limited access to global pharma giants.

APIs and Contract Manufacturing

The API, clindamycin phosphate, is supplied by specialized chemical manufacturers:

• HG Chemicals (India): One of the predominant API suppliers, offering high-purity clindamycin phosphate suitable for pharmaceutical manufacturing.

• Nacalai Tesque (Japan): Supplies APIs for research and commercial purposes, including clindamycin derivatives.

• Matsui Pharmaceuticals (Japan): Engaged in both API production and finished formulations.

It is common for pharmaceutical companies to outsource manufacturing via Contract Manufacturing Organizations (CMOs). These include:

• Samsung Biologics (South Korea): Known for large-scale API production.

• Lonza Group (Switzerland): Offers custom manufacturing solutions for APIs and finished dosage forms.

• Hetero Labs (India): Provides comprehensive API synthesis and formulation contract services.

Regulatory and Supply Chain Considerations

The supply of Clindagel hinges on regulatory approvals, manufacturing quality standards, and supply chain stability. Many generic manufacturers operate under strict compliance with Good Manufacturing Practices (GMP), enabling their products to meet international standards. For instance, suppliers obtaining FDA approval or equal certifications (EMA, TGA, etc.) ensure their products can be reliably exported and used globally.

Impact of Market Dynamics

The fragmentation of the supply chain, especially in emerging markets, increases supply resilience but also introduces variability in quality control. Industry consolidation has led to fewer but larger suppliers capable of meeting global demands, stabilizing supply but possibly impacting prices.

Supply Chain Bottlenecks and Future Trends

Recent disruptions due to global events, such as the COVID-19 pandemic, have affected raw material availability, including the APIs for Clindagel. The industry is gradually moving toward more diversified sources, with regional production hubs in India and China expanding their API manufacturing capacity to reduce reliance on a few suppliers.

Conclusion

The supply landscape for Clindagel and its equivalents is characterized by a mix of multinational pharmaceutical companies, regional generic manufacturers, and specialized API producers. Key players include Ind-Swift, Sun Pharma, LG Chemical, and others, supporting global demand through multiple channels. Ensuring a stable and compliant supply chain is vital for continuous access to this essential dermatological therapy.

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Key Takeaways

• Diverse supplier base: Multiple manufacturers, particularly in India and Europe, supply Clindagel and its generics, ensuring competitive pricing and availability.

• API sourcing: High-quality APIs from suppliers like HG Chemicals and contract manufacturers underpin production stability.

• Regulatory compliance: Suppliers with stringent GMP adherence and international approvals dominate the global supply chain.

• Market resilience: Industry consolidation and manufacturing diversification mitigate supply disruptions.

• Future outlook: Emphasis on localized API manufacturing and supply chain resilience will sustain Clindagel access amidst global disruptions.

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FAQs

1. Who are the primary global suppliers of Clindagel?
   Major suppliers include Indian pharma companies like Ind-Swift and Sun Pharma, along with European manufacturers like Siegfried AG, all producing both the finished formulation and APIs.

2. Are generic versions of Clindagel equivalent in quality?
   Yes, provided they meet regulatory standards such as GMP, and are approved by relevant authorities (FDA, EMA). The active ingredients and formulation processes are closely regulated.

3. How does API sourcing impact Clindagel supply?
   Reliable API supply from high-quality manufacturers ensures manufacturing continuity of Clindagel. Disruptions in API production can impact the availability of finished products.

4. Are there regional differences in Clindagel suppliers?
   Yes, regions like India and China dominate generic API and formulation manufacturing, while Europe and the US tend to rely on both domestic and imported products.

5. What future trends could affect Clindagel suppliers?
   Growing regulatory scrutiny, API sourcing diversification, and local manufacturing initiatives are shaping future supply stability, potentially reducing costs and improving availability.

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Sources

[1] GlobalData, "Top Pharmaceutical Suppliers in Dermatology," 2022.
[2] U.S. Food & Drug Administration (FDA), "ANDA Approvals and Drug Master Files," 2023.
[3] MarketWatch, "Generic Drugs Market Report," 2023.
[4] Indian Pharmaceutical Alliance, "API Manufacturing in India," 2022.
[5] European Medicines Agency (EMA), "Regulatory guidelines for topical antibiotics," 2023.