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Suppliers and packagers for HER STYLE
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HER STYLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novast Labs | HER STYLE | levonorgestrel | TABLET;ORAL | 207976 | ANDA | Northstar Rx LLC | 16714-809-01 | 1 BLISTER PACK in 1 CARTON (16714-809-01) / 1 TABLET in 1 BLISTER PACK | 2016-03-11 |
| Novast Labs | HER STYLE | levonorgestrel | TABLET;ORAL | 207976 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-352-01 | 1 BLISTER PACK in 1 CARTON (50742-352-01) / 1 TABLET in 1 BLISTER PACK | 2022-11-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for HER STYLE
HER STYLE pharma suppliers: Who manufactures “Her Style” and what supply-chain IP risks exist?
No complete, reliable basis exists to identify “HER STYLE” as a specific, FDA-regulated pharmaceutical product (active ingredient, dosage form, strength, labeler, or NDA/ANDA/BLA). Without product identity, any supplier list would be speculative and non-actionable.
What suppliers make “HER STYLE” if it is a branded prescription drug?
Featured snippet answer: None can be listed from verified sources because “HER STYLE” does not uniquely map to a single pharmaceutical product identity.
Labeler and manufacturer: what must be known to build a supplier map
A supplier map for a prescription drug requires, at minimum:
- Active ingredient(s) and strength(s)
- Dosage form (tablet, capsule, injection, topical, transdermal, etc.)
- Route of administration
- US labeler name and listing under the FDA’s drug establishment inventory / labeling
- NDA/ANDA/BLA number
- Orange Book entry and application holder
How do you verify “HER STYLE” suppliers using FDA sources like the Orange Book and Drugs@FDA?
Featured snippet answer: No supplier verification can be performed because the product cannot be uniquely identified.
Orange Book path
A defensible supplier list is typically derived by linking:
- Orange Book NDA/ANDA holder(s)
- Listed patents tied to that application
- Dosage forms and strengths that correspond to the commercial product
- Proprietary name variants and labeler names
Drugs@FDA path
A defensible supplier list is typically derived by linking:
- Drugs@FDA application details (approval, applicant/labeler, dosage form, manufacturer)
- FDA label (current labeling often shows manufacturer and packager)
- Postmarketing labeling revisions that can change responsible parties
What generic or private-label “HER STYLE” supply risks exist?
Featured snippet answer: None can be quantified because “HER STYLE” cannot be tied to a specific marketed drug and its regulatory application(s).
Private-label and relabeling changes the “supplier”
If “HER STYLE” is a private-label or marketing name, supply chain visibility often shifts to:
- Contract manufacturers (CMOs) and packagers
- Drug substance (API) suppliers
- Secondary manufacturers for sterile fill-finish or device integration
- Distributor-only branding with unchanged underlying application
Which contract manufacturing organizations (CMOs) supply “HER STYLE” products?
Featured snippet answer: No verified CMO list can be provided without a defined drug identity (application number or labeler/manufacturer name).
Why “HER STYLE” alone is insufficient
Contract manufacturing assignments are tied to:
- Specific dosage form manufacturing sites
- Specific submission CMC sections
- Batch record signing entities and establishment registration numbers
- Changes after FDA inspections or process updates
Does “HER STYLE” have biosimilar or generic substitution exposure?
Featured snippet answer: Not determinable because the product identity (biologic vs small molecule) is not established.
If it is a biologic
Supplier risk would focus on:
- BLA holder and manufacturer networks
- Biosimilar interchangeability status
- Patent estate timelines for biologics (reference product exclusivities, thicket)
If it is a small molecule
Supplier risk would focus on:
- Orange Book patent expiries
- Patent listing scope by dosage form
- ANDA filing and Paragraph IV litigation
What filings and investigations could reveal “HER STYLE” manufacturing sources?
Featured snippet answer: None can be listed because there is no product-to-registry match.
Evidence classes that typically surface suppliers
- FDA inspection assignment records (establishment-level)
- Form 483 outcomes and Warning Letters (site-specific)
- Court filings tying generic/CMO supply claims to the reference product
- Import alerts and customs holds for specific establishments
Commercial supplier strategy for “HER STYLE”: how buyers typically source
Featured snippet answer: Not applicable without the underlying drug identity and regulated application.
What a real “supplier” decision usually requires
- Confirmed labeler and manufacturing site(s)
- Quality systems and validation packages
- Regulatory status by application type (NDA vs ANDA vs BLA)
- Lead times and change control obligations
- IP and patent-risk assessment tied to the specific listed dosage forms
Key Takeaways
- “HER STYLE” is not uniquely identifiable as a single FDA-regulated pharmaceutical product from the provided prompt.
- No verified supplier list, manufacturer network, or contract manufacturer mapping can be produced without a definable product identity (active ingredient/dosage form/labeler or NDA/ANDA/BLA linkage).
- Any “supplier” named without that linkage would be speculative and not fit for litigation, licensing, regulatory, or commercial sourcing decisions.
FAQs
- How can I identify the manufacturer of a branded drug using FDA labeling?
- What data fields are required to build an Orange Book-based supplier map?
- How do you determine whether a product name corresponds to multiple strengths or dosage forms under one NDA?
- What court filings or Paragraph IV notices usually disclose reference product manufacturing details?
- How do biosimilar and generic substitution risks differ by application type (BLA vs NDA/ANDA)?
References
- U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drugs@FDA: Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). https://www.accessdata.fda.gov/scripts/cder/ob/
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