Suppliers and packagers for metrocream

metrocream

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA	Galderma Laboratories, L.P.	0299-3836-45	1 TUBE in 1 CARTON (0299-3836-45) / 45 g in 1 TUBE	1995-09-20
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-960-45	1 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE	2009-06-18
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-711-45	1 TUBE in 1 CARTON (68308-711-45) / 45 g in 1 TUBE	2025-05-19

METROCREAM (metronidazole) Suppliers and Supply-Chain IP Map: Who Makes It, Who Controls Inputs, and What Patent/IP Barriers Exist

Last updated: May 26, 2026

MetroCream is a topically applied metronidazole product. The key procurement question is whether you are sourcing finished-goods MetroCream for distribution or sourcing metronidazole API and topical excipients for contract manufacturing. Patent and regulatory constraints are secondary to verifying what is actually on-label and what manufacturing process is controlled.

Who supplies METROCREAM (metronidazole) in the US and globally?

Answer: MetroCream is supplied in the US under approved NDA labeling by brand/marketing holders and manufactured by contract manufacturers and/or internal plants. For sourcing, the two practical supplier tiers are (1) the finished-goods NDA holder/manufacturer and (2) API and excipient suppliers feeding contract manufacturing.

Finished-goods supply chain: brand holder vs. contract manufacturer

For MetroCream, procurement teams typically confirm:

• Labeler (NDA/marketing holder) on the FDA product listing
• Manufacturer/labeler name on the package and FDA databases
• Distribution network (primary wholesaler or direct-to-distributor)

API supply chain: metronidazole

MetroCream’s active ingredient is metronidazole. Common metronidazole API sources are global specialty chemical manufacturers producing:

• Metronidazole API (bulk drug substance)
• Metronidazole-related intermediates (upstream for domestic or licensed manufacturing)

Excipients and topical base inputs

MetroCream’s topical base is typically built from a semisolid vehicle requiring:

• Emulsion/gel-formers or creams-formers (depending on formulation)
• Preservatives and stabilizers
• Packaging-grade components (tubes, crimp caps/liners)

Which companies manufacture METROCREAM formulations (cream/gel) and what dosing forms exist?

Answer: MetroCream is marketed as a metronidazole cream. The supplier base can include multiple contract manufacturing sites over time due to manufacturing change approvals and site transfers.

What dosing strength is supplied and how does that affect suppliers?

• MetroCream is typically sold in a single topical strength (commonly 0.75% metronidazole for rosacea indications in the US).
• Strength and presentation drive the packaging SKU and the blend/processing method used by the manufacturer. Different strengths generally imply different manufacturing batches, controls, and sometimes different scale-up recipes.

Cream vs. alternatives

If you are comparing supply availability, note that topical metronidazole is sold under other brands too, and some markets carry different packaging and excipient systems. Contract manufacturing for “metronidazole cream” can be shared across multiple labelers if the formulation is equivalent and licensed.

What patents protect METROCREAM and can they block alternative sourcing or private label?

Answer: MetroCream’s IP barrier is the Orange Book patent estate tied to the approved NDA. If the product is formulation- or method-of-use-protected, it can constrain noninfringing private label manufacturing or delay entry for generics.

How to map the patent estate to supplier risk

Supplier due diligence should track:

• Orange Book-listed patents tied to the specific NDA and strength
• Patent types likely present for topical products:
  • Composition/formulation patents (vehicle + drug concentration + stability)
  • Method-of-use patents (indication-specific treatment)
  • Manufacturing process patents
• Expiration dates and whether any patents expire earlier than exclusivity

What is the Orange Book status of METROCREAM (metronidazole cream)?

Answer: Orange Book status determines whether generic/authorized alternatives can legally substitute for the brand. The decisive data points are:

• NDA number(s) for MetroCream
• Orange Book listed patents with expiration and patent numbers
• Whether exclusivities (drug product, new chemical entity, etc.) have been granted or still apply

When does METROCREAM lose exclusivity, and what does that mean for sourcing options?

Answer: Loss of exclusivity affects the economics of sourcing and private label manufacturing. Entry risk rises when:

• Orange Book patents expire (or are cleared via settlement or final court decisions)
• Exclusivity periods end (if applicable)

Paragraph IV or litigation timing

If a generic or alternative manufacturer files a Paragraph IV certification, it can trigger:

• Automatic 30-month stay (if the case is filed and stays are applicable)
• Settlement agreements that delay supply availability
• Launch timelines aligned to court outcomes or settlement dates

What generic entry risks exist for METROCREAM?

Answer: Risks depend on whether the Orange Book estate still blocks approvals or forces narrow labeling and formulation design changes.

Manufacturing/IP barriers

Key barriers for suppliers:

• Vehicle and stability requirements (formulation patents)
• Indication language (method-of-use patents)
• Process constraints (manufacturing method patents)
• Bioequivalence requirements do not typically apply to topicals the same way as systemic drugs, but formulation equivalence is still tightly controlled through chemistry, manufacturing, and controls (CMC)

Which contracts or licensing deals affect METROCREAM supply?

Answer: Supply stability often comes from:

• Long-term contract manufacturing agreements
• API supply agreements (especially if the API is sourced from a single or qualified supplier)
• Licensing of formulation rights or manufacturing know-how for contract sites

How licensing shows up operationally

Look for:

• Sudden manufacturer site changes
• Changes in packaging imprinting or labeler/manufacturer splits
• CMC update patterns aligned to manufacturing authorizations

What FDA status and labeling issues matter for suppliers?

Answer: Suppliers need to match:

• The approved labeling (strength, indication, and dosing instructions)
• The drug product identity and formulation controls
• Any REMS constraints (topical metronidazole generally does not carry REMS, but this must be verified for the specific NDA listing)

How does METROCREAM compare with other topical metronidazole brands and their suppliers?

Answer: Competitive supply is driven by:

• Whether alternative brands are equivalent products with different manufacturers
• Whether generics can be substituted under pharmacy benefit rules
• Availability of contract manufacturing capacity for metronidazole creams

Key comparison axes

• Ingredient: metronidazole (API grade and specification)
• Vehicle: determines texture, stability, and patient acceptability
• Pack: tube size, carton format, lot traceability
• Storage conditions: impacts distribution and shelf-life supply planning

Table: Procurement checklist for METROCREAM suppliers

Procurement goal	What to verify	Why it matters
Buy finished MetroCream	NDA labeler, manufacturer/packager, lot traceability	Avoid unapproved or non-equivalent product
Reduce supply risk	Qualified secondary contract manufacturer capability	Prevent single-site disruptions
Ensure CMC match	Formulation composition ranges, excipient specs, stability data requirements	Avoid batch rejection and regulatory drift
Lower cost	Alternate qualified metronidazole API sources	Mitigate API price spikes
Private label feasibility	Orange Book patent estate and noninfringing formulation design	Avoid patent infringement exposure
Generic substitution strategy	Orange Book status and exclusivity end dates	Timing for authorized generic or generic procurement

Key Takeaways

• MetroCream supply is best handled via a two-tier sourcing model: finished-goods manufacturer/labeler and upstream metronidazole API and excipient inputs.
• Patent and exclusivity constraints are governed by the Orange Book NDA patent estate. These determine whether alternative sourcing is substitution-eligible or private-label feasible without litigation exposure.
• The largest supplier risk for topical products is CMC equivalence, not system-wide pharmacokinetics. Contract manufacturing capacity and validated formulation controls drive continuity.

FAQs

1. How do I identify the actual manufacturer of METROCREAM sold in the US?
2. Are METROCREAM private label versions allowed if metronidazole cream is generic?
3. What Orange Book patents typically cover topical metronidazole creams and formulations?
4. When generic metronidazole cream can launch, what changes are needed for CMC compliance?
5. What supply-chain risks occur when metronidazole API is sourced from a limited number of qualified plants?

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.