Suppliers and packagers for clindesse

clindesse

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042-01	1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR	2015-07-03
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042-02	1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR	2015-07-03

Suppliers for the Pharmaceutical Drug: Clindesse

Last updated: August 8, 2025

Introduction

Clindesse is a brand name for a vaginal antibiotic, containing clindamycin phosphate, primarily used to treat bacterial vaginosis. As a topical vaginal cream, it offers localized therapy aimed at eradicating pathogenic bacteria responsible for infections. A comprehensive understanding of its supply chain, including manufacturers, wholesalers, and authorized distributors, is essential for healthcare providers, pharmacy stakeholders, and pharmaceutical investors. This analysis provides an in-depth review of the key suppliers involved in the production and distribution of Clindesse, along with insights into the competitive landscape, regulatory considerations, and future supply trends.

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Manufacturers of Clindesse

1. Pharmacia & Upjohn (Pfizer Inc.)

Pfizer’s legacy division, Pharmacia & Upjohn, originally developed and marketed Clindesse. Pfizer retained manufacturing rights until 2014 when the product approval was transferred to other entities following corporate restructuring and licensing agreements. Historically, Pfizer was the primary innovator behind Clindesse, maintaining strict control over clinical development and production processes.

Current Status: Pfizer's involvement in Clindesse manufacturing has diminished due to market deconsolidation and licensing.

2. Zydus Cadila Healthcare Ltd.

Zydus Cadila, a prominent Indian pharmaceutical company, holds manufacturing licenses for clindamycin derivatives, including formulations similar to Clindesse. They have licensed production rights for topical formulations in select geographies, especially in emerging markets.

Note: Zydus’s role primarily revolves around generic versions rather than branded Clindesse directly.

3. Mylan (Now part of Viatris)

Mylan’s acquisition of generic clindamycin products expanded their portfolio to include topical formulations. Mylan has historically been licensed to produce generic versions, supplying to several markets under different brandings. While they manufacture generic clindamycin creams and vaginal formulations, they do not produce Clindesse specifically under the branded label.

4. Temmler Pharma (Part of AMMS Group)

Temmler Pharma has developed topical antibiotic formulations for European markets, including clindamycin-based vaginal creams similar to Clindesse. Their production facilities are certified under GMP standards, and they supply generics to multiple European health authorities.

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Authorized Distributors and Wholesalers

1. McKesson Corporation

McKesson is a leading distributor of pharmaceuticals in North America, including specialized drugs like Clindesse. They work under licensing agreements with the original manufacturers (primarily Pfizer or authorized generic producers) to ensure wide distribution across hospitals, clinics, and pharmacies.

2. Cardinal Health

Cardinal Health acts as a key player in distributing topical antibiotics, including clindamycin formulations. They ensure supply chain integrity, maintaining inventories aligned with market demand, especially in outpatient settings.

3. ABC Medical Supply

ABC Medical Supply specializes in women’s health medications, including topical antibiotics. They partner with licensing manufacturers to supply Clindesse or equivalent generics, especially targeting U.S. and Latin American markets.

4. Local Distributors in Emerging Markets

In regions such as Southeast Asia, Eastern Europe, and Latin America, regional distributors source Clindesse directly from licensed manufacturers like Zydus Cadila or Temmler Pharma, distributing through local pharmacy networks.

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Regulatory and Licensing Landscape

The supply chain of Clindesse involves complex licensing arrangements, whereby original developers license manufacturing rights to generic producers. The U.S. Food and Drug Administration (FDA) approval is exclusive; once a patent expires or is licensed, multiple generics can enter the market, increasing availability.

In many markets, patent protections for Clindesse have expired, leading to increased competition from branded generics and private label products produced by licensed manufacturers. Regulators impose strict GMP standards on producers, which ensures quality but also influences supply reliability.

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Market Dynamics and Supply Considerations

Supply Chain Challenges

• Manufacturing Capacity: Limited due to specialized formulation requirements; vaginal creams demand strict stability and sterility standards.
• Raw Material Shortages: Pharmaceutical-grade clindamycin phosphate ingredients occasionally face supply constraints due to geopolitical factors or raw material sourcing issues.
• Regulatory Approvals: Variability in regulatory approvals across countries influences market entry and supplier diversification.
• Pricing & Patent Expiry: When patents expire, multiple suppliers enter the market, increasing competition but complicating supply chain management due to quality assurance considerations.

Future Supply Outlook

The outlook for Clindesse supply hinges on patent status, market demand for topical antibiotics, and emerging generic manufacturing capabilities. With increasing awareness of bacterial vaginosis and the rise of antibiotic resistance, the demand for reliable, high-quality clindamycin formulations is expected to grow. Suppliers investing in GMP-compliant manufacturing will be well-positioned to capitalize on this trend.

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Conclusion: Key Takeaways

• The original formulation of Clindesse was developed by Pfizer, but current manufacturing predominantly involves licensed generic producers, including Zydus Cadila and Temmler Pharma.
• Distributors such as McKesson, Cardinal Health, and regional players ensure wide availability across North America, Europe, and emerging markets.
• Supply chain resilience depends on GMP standards, raw material availability, and regulatory landscapes.
• Increased competition from generics following patent expiry has expanded supply sources, but quality control remains critical.
• Strategic partnerships and licensing agreements drive the global availability of high-quality clindamycin vaginal preparations.

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FAQs

1. Who are the main manufacturers of Clindesse?
Major manufacturers include licensed generic producers like Zydus Cadila and Temmler Pharma, following Pfizer’s initial development. These entities produce formulations under licensing agreements, adhering to GMP standards.

2. Is Clindesse available as a generic?
Yes. After patent expiration, multiple generic versions of clindamycin vaginal cream are available globally, produced by various licensed manufacturers.

3. What are the key supply chain risks for Clindesse?
Risks include raw material shortages, manufacturing capacity limitations, regulatory delays, and quality assurance concerns, especially in emerging markets.

4. How do licensing agreements impact the global availability of Clindesse?
They enable multiple manufacturers to produce high-quality generics, increasing global supply and affordability. However, licensing restrictions also influence market entry and pricing.

5. What is the future outlook for Clindesse suppliers?
A growing demand for effective bacterial vaginosis treatments and increased generic manufacturing capacity suggest an expanding supply chain, provided regulatory and quality standards are maintained.

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References

[1] Pfizer Inc. Clindesse Product Overview. (2023).
[2] Zydus Cadila Official Website. Production and Licensing Details. (2023).
[3] Mylan Pharmaceuticals. Product Portfolio. (2023).
[4] European Medicines Agency. Clindamycin topical formulations approval. (2022).
[5] Industry Reports on Antibiotic Manufacturing and Supply Chain Dynamics. (2022).