Suppliers and packagers for CLEOCIN T

CLEOCIN T

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-3743-1	1 TUBE in 1 CARTON (59762-3743-1) / 30 g in 1 TUBE	1987-01-07
Pfizer	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-3743-2	1 TUBE in 1 CARTON (59762-3743-2) / 60 g in 1 TUBE	1987-01-07
Pfizer	CLEOCIN T	clindamycin phosphate	LOTION;TOPICAL	050600	NDA	Pharmacia & Upjohn Company LLC	0009-3329-01	1 BOTTLE in 1 CARTON (0009-3329-01) / 60 mL in 1 BOTTLE	1989-05-31

CLEOCIN T (clindamycin phosphate 1% topical gel) Suppliers: Who Manufactures and Supplies the Brand and Generic Supply Chain

Last updated: June 5, 2026

CLEOCIN T’s supply chain is anchored by (1) the brand’s labeled product supply for the US market and (2) multiple generic manufacturers that bottle, pack, and distribute clindamycin phosphate topical gel under NDA/ANDA distribution channels. The practical “suppliers” for customers are typically the labeled-products manufacturer(s) and the generic fill-finish and packaging network supporting ANDA supply.

Who supplies CLEOCIN T clindamycin phosphate topical gel in the US?

The key “suppliers” for CLEOCIN T are the company listed as the NDA holder/labeler and the company that manufactures the finished dosage form (including contract manufacturers and packagers). For a topical gel, the supplier set commonly spans:

• NDA labeler (marketing authorization holder / distributor for US labeling)
• Finished-goods manufacturer of the gel bulk-to-finished product
• Packager/labeler (if different from the finished-goods site)
• Wholesale distributors serving pharmacies, clinics, and mail order

Actionable supplier mapping depends on the current FDA labeler/manufacturer entries in the US labeling and the Orange Book/Drug listing crosswalk for the specific strength and dosage form (CLEOCIN T, topical gel, 1%).

What are the common finished-dose supplier types for CLEOCIN T?

• Finished dosage form manufacturer (gel preparation, homogeneity validation, packaging into tubes)
• Contract fill-and-finish/packager (tube filling, crimping, cartonization, labeling)
• Direct distribution to wholesalers or via 3PL networks

Which companies manufacture generic clindamycin phosphate 1% topical gel (ANDA suppliers)?

Generic “suppliers” are the ANDA holders and their commercial manufacturers for clindamycin phosphate topical gel 1%. In practice, multiple ANDAs exist for the same drug strength/dosage form, each with different manufacturing sites and distribution footprints. Generic supply typically includes:

• ANDA labeler (marketing authorization holder for generic)
• One or more manufacturing sites for gel bulk and finished product
• Distribution partners (wholesalers, specialty pharmacy channels where applicable)

How to identify the active manufacturing supplier for a specific generic SKU?

For topical products, supplier identity for a given tube lot is derived from:

• the FDA drug product listing / labeler and manufacturer lines for that NDC
• the lot-level manufacturer code on the carton/tube (varies by pack format)
• the ANDA labeler’s commercial supply agreement

Without the specific NDCs you care about, a definitive list of current active manufacturers cannot be produced.

What is the Orange Book status of CLEOCIN T and how does it affect supplier eligibility?

For supplier selection, patent/exclusivity status matters because it shapes:

• when ANDA suppliers can enter
• whether authorized generics exist
• whether licensing restricts specific manufacturing processes

Does CLEOCIN T have active exclusivity that constrains suppliers?

Clindamycin phosphate topical gel (1%) is a mature product class. Current supplier breadth is usually driven by generic entry rather than active brand exclusivity. Orange Book status typically determines whether additional Paragraph IV challenges exist or whether suppliers can file/launch without authorization.

A precise Orange Book-driven supplier constraint requires the specific FDA product record and patent list for CLEOCIN T (NDA and formulation identifiers).

Which manufacturing sites supply CLEOCIN T tubes and cartons?

Topical gels are typically supplied as:

• tubes (primary packaging)
• cartons (secondary packaging)
• labeled trade unit distributed through wholesalers

In a regulated supply chain, site-to-site manufacturing is controlled through:

• GMP batch release
• comparability and stability protocols for gel formulation
• packaging line qualification for tube filling and sealing

A complete list of sites requires the current FDA labeling/manufacturer entries for the exact NDC(s) of CLEOCIN T.

What supply risks exist for CLEOCIN T and clindamycin phosphate topical gel?

For customers sourcing CLEOCIN T or equivalents, supply-chain risk drivers include:

• single-site manufacturing dependence for the gel intermediate or finished packaging
• tube/closure component lead times
• viscosity and rheology controls affecting batch yield
• market-driven manufacturing prioritization when volumes are concentrated

Where do supply disruptions typically hit?

• fill-finish and packaging line constraints (tube filling rates and seal integrity)
• bulk gel homogenization failures
• raw material availability for clindamycin phosphate and excipients
• component lead times for tubes, caps, and cartons

CLEOCIN T vs generic clindamycin 1% topical gel suppliers: how do they compare?

From a procurement standpoint, comparison is not “brand vs generic” in therapeutic performance. It’s about:

• regulatory standing of the specific NDC
• manufacturing site pedigree and inspection history
• distribution availability by wholesaler
• lot-to-lot consistency data and traceability

What procurement artifacts should be demanded from suppliers?

• NDC-specific certificate of analysis (CoA) and release specs
• GMP manufacturing site information for the lots shipped
• drug product stability evidence (shelf-life claim substantiation)
• serialization/UDI compliance where applicable

Key Takeaways

• CLEOCIN T’s “suppliers” in the market are the NDA labeler/distributor for CLEOCIN T and the finished-goods manufacturers and packagers behind the labeled product.
• Generic clindamycin phosphate 1% topical gel is supplied by multiple ANDA holders with different manufacturing sites; supplier identity is NDC-specific.
• Patent and exclusivity status can constrain launch timelines but does not usually limit supplier breadth for mature clindamycin topical products; exact constraints require the current Orange Book record tied to the specific CLEOCIN T NDA/product.
• For sourcing decisions, the decisive dataset is the FDA NDC listing showing labeler and manufacturer lines, plus lot-level manufacturer identifiers for the tubes/cartons supplied.

FAQs

1. How do I find the manufacturer (not just the labeler) for CLEOCIN T tubes?
   Use the NDC-specific FDA listing for CLEOCIN T to extract the “Manufacturer” line tied to that NDC and corroborate with lot/label identifiers on the carton or tube.

2. Can a generic clindamycin phosphate 1% gel supplier change manufacturing sites after approval?
   Often yes through regulatory-approved changes, but the commercial product remains tied to an NDC and the current manufacturing sites listed for that product.

3. Do CLEOCIN T and generic clindamycin gel have the same inactive ingredients?
   Generics must meet product performance requirements; inactive ingredients can differ by formulation, so check the label for the exact excipient list for the specific NDC.

4. What is the main bottleneck in topical gel supply chain?
   For many topical gels, bottlenecks are packaging line capacity (tube filling/sealing) and critical excipient or tube component lead times more than active ingredient chemistry.

5. How does Paragraph IV litigation affect CLEOCIN T or generic clindamycin gel supply?
   Paragraph IV challenges can delay generic market entry or trigger settlement-driven entry timing; effects are NDC and ANDA specific and are resolved by the litigation/settlement terms tied to the challenged patents.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drug Products.