Suppliers and packagers for VELIVET

VELIVET

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	VELIVET	desogestrel; ethinyl estradiol	TABLET;ORAL-28	076455	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9051-67	3 POUCH in 1 CARTON (0555-9051-67) / 1 BLISTER PACK in 1 POUCH (0555-9051-79) / 1 KIT in 1 BLISTER PACK	2004-03-01

VELIVET suppliers: who manufactures the drug, API, and key components, and what to verify in vendor due diligence

Last updated: June 4, 2026

VELIVET supplier landscape depends on the drug’s exact formulation strength, dosage form, and market authorization holder. Without the specific jurisdiction label and product composition, a definitive supplier list cannot be produced.

If VELIVET refers to a named product in a specific country, supplier identification must be pulled from authoritative primary sources that list the manufacturer(s) on the drug label, the marketing authorization dossier, and the API manufacturing declarations.

What suppliers make VELIVET drug product (finished dosage form)?

Label-level manufacturer check (highest confidence)

• Identify the “Manufacturer” / “Manufacturing site” named on:
  • the commercial package insert,
  • the local marketing authorization holder’s dossier,
  • and regulator-maintained product listings for the target country.
• If VELIVET is distributed under a marketing authorization holder, the finished-goods manufacturer may be different from the holder.

How to determine contract manufacturer vs in-house

• Finished-dose manufacturing is commonly outsourced; verify whether the label lists:
  • a contract development and manufacturing organization (CDMO) or
  • the marketing authorization holder’s own manufacturing sites.
• Due diligence items to verify:
  • GMP manufacturing license number(s),
  • dosage form capability (tablet, capsule, oral solution, etc.),
  • batch release testing sites,
  • stability study responsibilities.

Which companies supply the VELIVET API (active pharmaceutical ingredient)?

API supplier identification workflow

• API manufacturer names appear in:
  • regulatory drug substance sections of the marketing authorization application,
  • DMF-linked submissions (where applicable),
  • and quality sections referencing the named API sites.
• Commercial supply can involve:
  • primary API manufacturer,
  • secondary re-packager or intermediate supplier,
  • and alternative qualified sources for supply continuity.

API due diligence checks

• Confirm:
  • API CEP/DMF status and reference number (if used in that jurisdiction),
  • polymorph/hydrate form specification,
  • particle size or crystallinity controls if relevant,
  • sterilization or endotoxin limits only if the drug is sterile (typically not for standard oral drugs).

What excipients and components suppliers are used for VELIVET formulations?

Excipients typically supplied via specialized ingredient vendors

• For oral solid dosage forms, excipient sourcing commonly includes:
  • fillers/diluents (e.g., microcrystalline cellulose, lactose),
  • binders (e.g., povidone),
  • disintegrants (e.g., croscarmellose sodium, sodium starch glycolate),
  • lubricants (e.g., magnesium stearate),
  • coating polymers and plasticizers if film-coated (e.g., hypromellose, PEG).
• For liquids, component sourcing expands to:
  • solvents (water, propylene glycol),
  • preservatives,
  • viscosity modifiers,
  • sweeteners and flavor systems.

How to confirm excipient supplier identity

• Excipient supplier names are often not listed publicly on labels.
• Identify excipient vendors via:
  • quality sections of regulatory files,
  • supplier qualification documentation in the supply chain,
  • or audited vendor lists shared by the manufacturing site under NDA.

What contract manufacturing networks support VELIVET supply chains?

Typical CDMO patterns

• Contract manufacturing for finished dosage forms often includes:
  • granulation and blending,
  • compression or encapsulation,
  • coating and packaging,
  • batch release testing and stability commitments.
• Supply chain resilience may include:
  • two qualified sites for bulk drug product,
  • dual packaging lines for blister or bottle formats,
  • secondary packaging supplier qualification.

What to verify for multi-site supply

• Site comparability and validation packages.
• Cross-site master batch records and change control control strategy.
• Cold chain only if the dosage form requires it.

What regulatory listings show VELIVET suppliers in the US (Orange Book) and EU (EPAR)?

US (Orange Book)

• The Orange Book typically lists:
  • drug products, active ingredient, strength, dosage form,
  • listed patents,
  • and sometimes manufacturer information for the listed product.
• For exact supplier identification, the manufacturing sites are usually confirmed through FDA labeling and submitted chemistry/manufacturing controls (CMC), not only the Orange Book entry.

EU (EMA / national procedures)

• EPAR and national authorization databases can include:
  • marketing authorization holder,
  • product-specific manufacturing details,
  • sometimes site names for release testing and batch manufacture.

What to verify

• Match the exact product name, strength, and dosage form.
• Confirm that the supplier listed is the one producing the commercial batches, not a historical site.

When multiple VELIVET versions exist, which supplier changes by strength or dosage form?

Strength- or form-specific manufacturing

• Different strengths and dosage forms can have:
  • different release sites,
  • different packaging suppliers,
  • different blend compositions and manufacturing processes.
• Supplier identification must map to:
  • the exact NDC (US) or local registration number (non-US),
  • and the exact formulation.

What generic or parallel-market versions reveal about suppliers

• If VELIVET has multiple branded or parallel imports, supplier changes are common for:
  • packaging,
  • wholesalers,
  • and sometimes finished-goods manufacturing.

How strong is the supplier dependency risk for VELIVET?

Dependency risk drivers

• Single API site dependency (no qualified second source).
• Single finished-dose manufacturing site dependency.
• Limited packaging line capacity (for blister vs bottle).
• Longer lead-time raw materials or excipients with limited suppliers.

Operational due diligence

• Verify:
  • quality agreements covering API and drug product testing,
  • batch release timeline SLAs,
  • audit frequency and remediation timeframes,
  • QMS alignment for change control.

Key Takeaways

• A reliable “suppliers for VELIVET” list requires the exact VELIVET product identity (jurisdictional label, dosage form, and strength) and validation against regulatory labeling/authorization data and CMC sections.
• Supplier names should be confirmed at three layers: finished dosage manufacturer, API manufacturer, and critical excipient/component vendors.
• Vendor due diligence should prioritize GMP license/site evidence, batch release testing location, and multi-site continuity.

FAQs

1. What documents list the manufacturer of the VELIVET finished drug product?
2. How can I identify the VELIVET API supplier from public sources?
3. Do excipient suppliers for VELIVET appear on drug labels or public regulatory summaries?
4. How do I confirm whether a VELIVET CDMO is responsible for batch release testing?
5. What triggers supplier changes across VELIVET strengths, packaging formats, or parallel imports?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. European Medicines Agency (EMA). EPAR and European public assessment reports.
3. FDA. Prescribing information and labeling resources for approved drug products.