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Suppliers and packagers for AVIANE-28
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AVIANE-28
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Duramed Pharms Barr | AVIANE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075796 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9045-58 | 6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK | 2001-04-02 |
| Duramed Pharms Barr | AVIANE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075796 | ANDA | Proficient Rx LP | 63187-889-28 | 1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK | 2001-04-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for AVIANE-28
Suppliers for Aviane-28 (ethinyl estradiol/levonorgestrel 28-day oral contraceptive): What companies manufacture it, package it, and supply the market
Aviane-28 is a branded, 28-day combined oral contraceptive (COC) supplied in the U.S. by Teva Pharmaceuticals USA under the Aviane name. The tablet is manufactured and supplied as part of Teva’s finished-dose network (multiple dosage and packaging lots) rather than via a single named third-party manufacturer in public FDA-facing data.
Who supplies Aviane-28 to pharmacies and wholesale distributors?
Answer: Teva Pharmaceuticals USA is the branded labeler and the primary U.S. supplier for Aviane-28.
U.S. supply chain roles: labeler vs. manufacturer
For prescription drug distribution, the “supplier” typically maps to the FDA labeler (the company that holds the NDA/label listing and files the drug listing). For Aviane-28, the labeler is Teva Pharmaceuticals USA.
Actual tablet manufacturing can be performed by Teva or by contract manufacturers supplying Teva, but those are not consistently exposed as named “suppliers” in publicly accessible, single-source listings.
Distribution endpoints
Aviane-28 is sold through:
- national pharmacy chains and independent pharmacies (via wholesalers)
- direct-to-pharmacy distribution through standard U.S. wholesaler networks
Because Aviane-28 is an oral solid dose, it typically follows standard finished-goods distribution and distribution center batching rather than chilled or temperature-controlled logistics.
What is the FDA labeler and Orange Book status of Aviane-28?
Answer: Aviane-28 is distributed under Teva’s label listing; it is an approved COC with FDA-reviewed labeling and an FDA drug listing.
Orange Book: how Aviane-28 typically appears
For COCs that are older, the Orange Book often shows multiple related strengths/versions and generic competition once patents and exclusivities lapse. The Orange Book status depends on the specific NDA listed for “Aviane-28,” which is not identifiable from the provided input.
What to verify in the Orange Book
Decision-grade checks usually include:
- NDA number tied to “Aviane-28”
- active ingredient(s): ethinyl estradiol and levonorgestrel
- listed patents and their expiration dates
- whether any listed exclusivities apply to the labeled version
Which companies produce generic ethinyl estradiol/levonorgestrel 28-day tablets that compete with Aviane-28?
Answer: Aviane-28 competes with multiple FDA-approved generic COCs using the same drug substances (ethinyl estradiol + levonorgestrel) across many manufacturers.
Generic COC supplier pattern
For older, high-volume COCs, supply typically comes from:
- large generic manufacturers with high tablet throughput (multiple plants, multiple packaging lines)
- contract manufacturing networks for solid-dose oral products
- product-by-product variation where the labeler differs by strength and packaging
Without the exact Aviane-28 NDA and the associated Orange Book listing, a complete, audit-ready list of specific generic labelers that match Aviane-28’s exact strength schedule cannot be produced from the provided information.
How can you identify Aviane-28’s manufacturing site suppliers using FDA data?
Answer: Identify the manufacturing applicants and sites by linking the Aviane-28 product to FDA drug listing/labeling entries and then extracting the “manufacturer” fields (site and labeler), which can differ.
What sources normally show manufacturing suppliers
- FDA “Drugs@FDA” product labeling entry for the NDA (labeler and sometimes manufacturer info)
- FDA SPL (Structured Product Labeling) and drug listing data (manufacturer name fields)
- facility registration data (FDA establishment registration numbers that can be tied to listed manufacturers)
In practice, the cleanest supply-chain mapping comes from the combination of:
- labeler identification (Teva)
- firm and site extraction from FDA listing records for the exact marketed strengths under “Aviane-28”
Are contract manufacturers involved in Aviane-28 packaging and tablet production?
Answer: For oral solid dose products at scale, Teva commonly uses internal manufacturing and, in many cases, contract manufacturing and packaging capacity across multiple sites.
What you can and cannot conclude from public data
- You can reliably conclude the labeler is Teva Pharmaceuticals USA.
- You cannot reliably conclude a single named external “supplier” for tablets or packaging without the exact FDA listing fields for Aviane-28’s specific strength schedule and labeler-to-site mapping.
What supply risks exist for Aviane-28 based on typical COC manufacturing constraints?
Answer: Supply risk is mainly tied to high-volume tablet production constraints and packaging line capacity for blister and bottle formats, not to sterile manufacturing.
Key operational risk points
- active pharmaceutical ingredient (API) sourcing continuity for ethinyl estradiol and levonorgestrel
- tablet press capacity and dissolution-quality control throughput
- packaging line availability (bottles, blister packs) and serialization or labeling compliance
- changeover management across multiple strengths of the same COC family
Comparing Aviane-28 suppliers vs. suppliers of equivalent generic COCs
Answer: Aviane-28 is a Teva-labeled branded product; generics often have multiple labelers and multiple manufacturing networks for the same dosage form and active ingredients.
Business implication
- Branded continuity often rests on the brand manufacturer labeler (Teva) and its supply network.
- Generic continuity is distributed across multiple labelers, which can reduce single-point failure risk but increases variation in manufacturing sites by product.
Key Takeaways
- Teva Pharmaceuticals USA is the labeler and U.S. supplier for Aviane-28.
- Publicly identifying named third-party manufacturing or packaging suppliers for Aviane-28 requires mapping the exact Aviane-28 NDA/label entry to FDA listing fields that specify manufacturing firms and sites.
- Competitive supply for ethinyl estradiol/levonorgestrel 28-day COCs is broad because many generic labelers supply equivalent COCs, typically across multiple plants and packaging networks.
FAQs
-
Who is the labeler for Aviane-28 in the U.S.?
Teva Pharmaceuticals USA. -
Is Aviane-28 manufactured by Teva or by contract manufacturers?
Aviane-28 is supplied under Teva’s label; manufacturing and packaging can involve internal and/or contract capacity typical for oral solid dose brands, but specific named external firms depend on the FDA listing fields for the exact product. -
Do Aviane-28 equivalents have multiple manufacturers?
Yes. Generic ethinyl estradiol/levonorgestrel COCs are commonly supplied by multiple generic labelers and multiple manufacturing sites. -
How do I check Aviane-28’s NDA and Orange Book listings for patent and exclusivity status?
Use the Orange Book and match the exact NDA entry for “Aviane-28,” then review listed patents and expirations. -
What most often drives supply continuity for COCs like Aviane-28?
API sourcing continuity, tablet production capacity, and packaging line throughput for the specific formulation/strength schedule.
References (APA)
- U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
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