Suppliers and packagers for RETIN-A MICRO

RETIN-A MICRO

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	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475	NDA	Bausch Health US LLC	0187-5146-02	24 TUBE in 1 TRAY (0187-5146-02) / 2 g in 1 TUBE	2017-10-23
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475	NDA	Bausch Health US LLC	0187-5146-50	1 BOTTLE, PUMP in 1 CARTON (0187-5146-50) / 50 g in 1 BOTTLE, PUMP	2017-10-23
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475	NDA	Bausch Health US LLC	0187-5148-02	24 TUBE in 1 CARTON (0187-5148-02) / 2 g in 1 TUBE	2014-01-28
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475	NDA	Bausch Health US LLC	0187-5148-50	1 BOTTLE, PUMP in 1 CARTON (0187-5148-50) / 50 g in 1 BOTTLE, PUMP	2014-01-28

Suppliers and packagers for RETIN-A MICRO

Last updated: June 5, 2026

Suppliers for RETIN-A MICRO (tretinoin) topical microsphere gel: who manufactures, markets, and supplies generics vs brand

RETIN-A MICRO is a branded topical tretinoin microsphere product. Supplier mapping hinges on (1) the NDA/labeler for US distribution and (2) Orange Book listed manufacturers for each strength and dosage form, including any authorized generics or ANDA partners.

Who manufactures RETIN-A MICRO in the US and supplies it to distributors?

Featured snippet answer: The US “labeler” (FDA SPL/labeling party) is the primary supplier for brand RETIN-A MICRO. Exact manufacturer sites and component suppliers are not disclosed in FDA labeling; the operational supplier is the NDA holder and its contract manufacturers used for gel fill-finish and packaging.

US labeler and distribution structure

RETIN-A MICRO is marketed as a tretinoin topical microsphere gel for acne. Under standard US practice, the product’s supplier chain has these layers:

• NDA holder / labeler (responsible for FDA labeling and product release)
• Contract manufacturing organization(s) (drug substance and drug product manufacturing, gel compounding)
• Packaging and distribution partners (primary packaging, cartons, and wholesale distribution)

How to identify the exact “supplier” per strength

For each marketed strength (commonly indexed by NDC), the definitive supplier is determined by:

• NDC labeler in FDA SPL
• Orange Book “Applicant/Manufacturer” for any listed products (brand and ANDAs)
• Package insert labeling “Manufactured for” / “Distributed by” line items

What Orange Book listings exist for RETIN-A MICRO, and which applicants are suppliers?

Featured snippet answer: Orange Book lists the NDA (and any ANDAs) tied to tretinoin microsphere gel, each with an applicant/manufacturer tied to specific Orange Book product entries and patent/ exclusivity records. Supplier identification is done at the Orange Book product level by strength and dosage form.

Orange Book status: what to extract for supplier due diligence

For RETIN-A MICRO, the supplier due diligence package should be built from:

• Orange Book entry for the referenced NDA
• Listed applicants/manufacturers by strength
• Any ANDA suppliers selling “authorized generic” or non-authorized generic equivalents
• Listed patents tied to the microsphere formulation and/or method-of-use

Table: how suppliers map in practice

Supplier role	Where confirmed	What it means operationally
Brand NDA labeler	FDA SPL / package labeling	Who releases and sells brand RETIN-A MICRO
Orange Book applicant/manufacturer	Orange Book product entry	Who is legally responsible for that listed product entry
Generic ANDA sponsor	Orange Book ANDA listings	Who supplies the generic equivalent (may differ by strength)
Authorized generic partner	If present	Same active ingredient, different labeling sponsor

Which generic or ANDA companies supply tretinoin microsphere gel like RETIN-A MICRO?

Featured snippet answer: Generic suppliers depend on which ANDAs are approved for the same strength/dosage form and whether they are listed in the Orange Book for the RLD reference. In the supplier market, multiple ANDA applicants can exist across strengths, sometimes with different manufacturers.

Generic entry risk controls that determine supplier viability

For RETIN-A MICRO-type products, supplier viability typically depends on:

• Microsphere gel formulation know-how (controlled release and stability)
• Scale-up and particle-size control for the microsphere system
• Bioequivalence strategy (usually waived or demonstrated depending on formulation and regulatory pathway)
• Patent challenge posture (Paragraph IV for patent waivers, or non-Paragraph IV with settlement)

What formulation manufacturing suppliers are involved in RETIN-A MICRO (microsphere gel tech)?

Featured snippet answer: Labeling rarely names raw material suppliers for tretinoin microsphere gels. The best available “supplier” identifiers are contract manufacturing firms for drug product and packaging houses for the marketed cartons.

What parts of the product supply chain matter most

Even without named vendors, the functional supplier dependencies for RETIN-A MICRO are stable across microsphere topical products:

• Microsphere formation and stabilization materials (polymeric matrix system)
• Tretinoin drug substance handling and micronization constraints
• Gel viscosity control and shelf-stability testing
• Primary packaging selection that preserves tretinoin stability

Supplier qualification checklist for diligence

A credible supplier assessment for this product category should verify:

• Experience with topical microsphere gels or comparable controlled-release semisolids
• Validation of mixing, milling, and particle-size distribution controls
• Stability data for tretinoin in gel vehicles across shelf life
• Sterility is usually not a driver for these topical gels, but microbial limits and preservatives are

Are there different suppliers for different strengths or dosage forms of RETIN-A MICRO?

Featured snippet answer: Yes. Supplier assignment can vary by NDC strength, even when the product is the same NDA. Different strengths can be manufactured or packaged at different sites, and NDC-level labelers can differ due to re-packaging or supply chain changes.

Why strength-level supplier differences matter

• Retailers and wholesalers buy by NDC.
• Hospitals and health systems procure by NDC.
• Contract manufacturers can swap sites without changing the NDA labeler, affecting lead times and quality history.

How do licensing and settlements affect who can supply RETIN-A MICRO equivalents?

Featured snippet answer: If there are active patents listed for the reference product and ANDA suppliers challenge them, settlements can define:

• when particular ANDA suppliers can launch
• whether supply is paused or limited
• which patents remain “carved out” for later challenges

What to map for settlement-driven supplier constraints

Supplier landscape work should tie:

• Orange Book patent list to ANDA Paragraph IV filings (where applicable)
• Court or settlement dates to launch entry windows
• Exclusivity blocks (if any) that restrict launches beyond simple patent expiry

What is the supplier landscape timeline for RETIN-A MICRO in the US market?

Featured snippet answer: Supplier count typically increases after patent expiry and any exclusivity periods lapse, then consolidates when ANDA suppliers exit due to low margin, formulation costs, or market share shifts.

Supplier timeline framework (actionable for monitoring)

• Brand exclusivity / early life: single primary supplier (NDA labeler + contract manufacturer)
• Post-patent: first generic launches (one or multiple ANDA suppliers depending on filings)
• Mature generic stage: NDC-level supplier consolidation and site switches
• Ongoing: inventory-driven substitutions and repackaging

Who supplies RETIN-A MICRO outside the US (parallel trade and cross-border equivalents)?

Featured snippet answer: Outside the US, “supplier” depends on national marketing authorization holders and local manufacturers. Parallel imports may use different batch release and packaging partners than the US labeler.

Cross-border supply chain drivers

• Country-specific marketing authorization
• Local GMP manufacturing and batch certification rules
• Packaging language and labeling compliance

How strong is the patent and exclusivity position that keeps supplier competition limited for RETIN-A MICRO?

Featured snippet answer: Supplier competition is constrained by Orange Book listed patents for RETIN-A MICRO’s reference NDA and any unexpired exclusivity (if present). Once those barriers fall, ANDA applicants can launch unless blocked by a later-expiring patent.

Supplier impact of patent estate structure

• A formulation patent can delay “same strength same dosage form” generic equivalence.
• A method-of-use patent can limit carve-outs even if some product characteristics are generic.
• Multiple patents expiring at different times can create stepwise entry.

Key Takeaways

• RETIN-A MICRO’s “supplier” in US practice is determined by the FDA labeler (NDA holder) and the Orange Book applicant/manufacturer entries by NDC/strength.
• Different suppliers can exist by strength even for the same branded product line.
• Generic supply of tretinoin microsphere gel depends on Orange Book barriers, including formulation and method-of-use patents and any settlement or exclusivity effects.
• The most reliable supplier map is NDC + Orange Book applicant/manufacturer + litigation/settlement timeline at the strength level.

FAQs

1. How can I identify the exact manufacturer for RETIN-A MICRO by NDC?
   Use FDA SPL/NDC labeler plus the Orange Book entry for the matching strength and dosage form.

2. Do ANDA suppliers for tretinoin microsphere gel differ across strengths?
   Yes, supplier and applicant/manufacturer mappings can vary by strength due to site-specific manufacturing and packaging.

3. What data sources show who is legally responsible for RETIN-A MICRO supply?
   Orange Book “applicant/manufacturer” and FDA SPL labeler plus the package labeling “manufactured for” line.

4. How do patent listings influence which generic suppliers can launch RETIN-A MICRO equivalents?
   Orange Book listed patents define launch timing and whether ANDAs need carve-outs, settlements, or wait for expiration.

5. Can parallel imports change the “supplier” of RETIN-A MICRO?
   Yes. Cross-border supply can involve different local marketing authorizations and packaging release partners.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. FDA. (Accessed via FDA Orange Book).
2. U.S. Food and Drug Administration. Structured Product Labeling (SPL) via DailyMed and FDA SPL. FDA. (Accessed via FDA SPL/NDC labeler data).