Suppliers and packagers for KARIVA

KARIVA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	KARIVA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	075863	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9050-58	6 POUCH in 1 CARTON (0555-9050-58) / 1 BLISTER PACK in 1 POUCH (0555-9050-79) / 1 KIT in 1 BLISTER PACK	2002-04-08

Suppliers for Kariva (ethinyl estradiol + desogestrel) tablets: who manufactures, packages, and supplies the US market

Last updated: May 28, 2026

Kariva is an oral contraceptive tablet marketed in the US by Actavis/Teva and supplied via multiple contract manufacturing and packaging channels. The drug’s supplier footprint is determined by the NDC-to-manufacturer mapping in FDA labeling and Orange Book/Drug Product databases, where you see the listed applicant/holder and the actual drug product manufacturer(s) responsible for formulation, filling, and packaging.

Who manufactures and supplies Kariva (desogestrel/ethinyl estradiol) in the US?

Answer: Kariva’s US supply chain is built around (1) the marketing authorization holder/applicant listed in FDA drug listings and (2) the manufacturing sites listed as drug product manufacturers in FDA databases and labeling.

Key supplier roles you should map

1. Applicant / NDA holder (marketing authorization holder)
   • Owns the FDA listing for the product and manages regulatory submissions.
2. Drug product manufacturer(s)
   • Manufactures the finished oral solid dosage form (tablet bulk through finished tablets).
3. Packaging site(s)
   • Bottling/blister packaging and labeling.
4. Labeler / NDC distributor
   • Often appears as the “labeler” on NDC records and can differ from the actual manufacturer.

Market implication

• When you build an interchangeability or supply-risk view for Kariva, the decisive datapoints are the FDA-registered drug product manufacturing sites tied to the NDCs currently on the market, not the brand’s historical marketing name changes.

What is the Orange Book status of Kariva and how does it identify suppliers?

Answer: Orange Book status tells you whether patents and exclusivities are active, while FDA listing data identifies the manufacturing supply chain for each listed NDC.

How Orange Book links to supplier mapping

• Orange Book ties patents to an FDA product entry.
• The FDA product listing (Drug Listing/Labeler-NDC mapping) ties that product entry to manufacturing and packaging sites.
• Supplier mapping is therefore done by joining:
  • Drug product active ingredient entry
  • NDCs
  • Manufacturing/packing site fields

Which companies supply the active ingredient vs the finished tablet for Kariva?

Answer: For Kariva, API supplier identity is rarely visible at the brand level in public FDA listing data. Public supplier visibility is strongest for the finished dosage form manufacturer (drug product) and the packager/labeler.

What you can verify from public FDA-facing records

• Finished tablet manufacturer(s) tied to specific NDCs
• Packager(s) tied to specific presentation formats (bottle vs blister if applicable)
• Applicant/holder as the listed responsible party for the NDA/BLA entry (as applicable)

What is commonly not reliably published in public listings

• The exact API manufacturer for ethinyl estradiol/desogestrel is often not explicitly enumerated in the brand listing metadata.

How do NDC variations affect Kariva suppliers?

Answer: Different NDCs for the same drug can point to different manufacturers and packagers. For oral contraceptive tablets, this is common due to:

• multiple sites qualified for manufacturing
• alternative packaging lines
• product line changes over time (site transfers)

Practical supplier mapping rule

• Treat each NDC as a distinct supply contract in a supplier-screening workflow.
• Don’t assume one manufacturer across all package sizes and presentations.

What contract manufacturing and packaging barriers exist for Kariva supply?

Answer: The main barriers are regulatory qualification and consistent tablet performance across manufacturing sites.

Typical barriers by role

• Tablet manufacturing
  • validated processes for granulation, compression, and dissolution
  • batch release testing and stability program alignment
• Packaging
  • blister/bottle packaging line validation
  • label printing control
  • secondary packaging supply continuity

Regulatory consequence

• Any new supplier must be qualified against the commercial product listing and must fit within FDA-accepted manufacturing and control specifications for the exact dosage form/NDC.

Which Kariva suppliers are relevant for generic or 505(b)(2) supply risk?

Answer: The suppliers relevant to generic and 505(b)(2) risk are the drug product manufacturing and packaging sites tied to the NDCs.

Why it matters

• A challenger may face:
  • limited access to preferred manufacturing capacity
  • longer qualification timelines if the applicant needs a different manufacturing site
  • potential supply constraints if the incumbent relies on a small number of qualified lines

What patent or exclusivity does Kariva rely on that could constrain supply?

Answer: Patent and exclusivity status does not directly determine who manufactures Kariva, but it can constrain market entry timing. If Orange Book-linked protections are active for the listed NDC presentations, generic supply is delayed even if manufacturing capacity exists.

How to use this for supplier planning

• If you are evaluating a new supplier or a competitive supply plan, you need:
  • active Orange Book entries for the exact NDCs
  • exclusivity clocks tied to that entry (if any)
  • the FDA listing for manufacturing/packager sites

Key Takeaways

• Kariva’s supplier network is identified through FDA NDC-to-manufacturer/packager records, not through brand name alone.
• Publicly visible supplier detail is strongest for finished dosage form manufacturing and packaging, while API suppliers are less consistently disclosed.
• Treat each Kariva NDC as its own supplier mapping target because manufacturing and packaging sites can vary by package presentation.
• Orange Book status informs market entry timing but does not replace NDC-level supplier mapping.

FAQs

1) Are Kariva suppliers the same across all NDCs?
Often not. NDC-level FDA listing records can map the same brand to different manufacturing/packaging sites across presentations.

2) Does Orange Book list the Kariva manufacturers?
Orange Book focuses on patents and exclusivities. Supplier manufacturers are typically identified via FDA drug product listing/NDC data associated with the same product entry.

3) Who is the applicant/holder for Kariva in the US?
The applicant/holder is shown in FDA labeling and product listing records tied to the Kariva NDA product entry.

4) Can contract manufacturers package Kariva under the same NDA?
Yes. Contract packaging and manufacturing sites can be qualified and listed against the NDA product, and this can change by NDC over time.

5) What supplier data is easiest to obtain for Kariva publicly?
The most accessible supplier detail is finished drug product manufacturer and packager/labeler tied to each NDC in FDA records.

References

(No citations provided because the required FDA/Orange Book/NDC source records for “Kariva” suppliers were not included in the input.)