Last Updated: July 21, 2026

Suppliers and packagers for LO-MALMOREDE


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LO-MALMOREDE

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 LO-MALMOREDE ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 209548 ANDA Mayne Pharma Inc. 51862-894-01 1 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK 2020-10-16
Novast Labs LO-MALMOREDE ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 209548 ANDA Mayne Pharma Inc. 51862-894-03 3 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK 2020-10-16
Novast Labs LO-MALMOREDE ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 209548 ANDA Dr. Reddy?s Laboratories Inc. 75907-087-28 1 BLISTER PACK in 1 PACKET (75907-087-28) / 1 KIT in 1 BLISTER PACK 2024-06-01
Novast Labs LO-MALMOREDE ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 209548 ANDA Dr. Reddy?s Laboratories Inc. 75907-087-62 6 BLISTER PACK in 1 CARTON (75907-087-62) / 1 KIT in 1 BLISTER PACK 2024-06-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: June 28, 2026

ecutive summary No complete, reliable supplier map can be produced for “LO-MALMOREDE” because the drug identity, active ingredient, dosage form, and reference product are not specified, and “LO-MALMOREDE” does not uniquely resolve to a single, mappable FDA/Orange Book or global trade-name record from which manufacturer and API/formulation suppliers can be enumerated.

What suppliers make LO-MALMOREDE pharmaceutical products and APIs?

Featured snippet answer: Not identifiable from the provided name alone.

How to map “LO-MALMOREDE” to an API and reference product

A supplier list requires a determinable target:

  • Drug substance (INN/USAN active ingredient)
  • Finished dosage form (tablet, capsule, oral solution, injection, etc.)
  • Strengths and labeling (US labeler, NDA/BLA, or marketing authorization holder)
  • Country-specific product code or submission identifier

Without that linkage, supplier identification would be guesswork, not patent- or regulatory-grade intelligence.

Which companies supply LO-MALMOREDE to pharmacies, hospitals, and distributors?

Featured snippet answer: Not determinable from the provided identifier.

What “supplier” means in regulatory terms

High-integrity supplier mapping usually pulls from one or more of:

  • FDA labeling “Labeler” (NDC)
  • Orange Book “Listed Drug” and manufacturing sites
  • Drug Master File (DMF) holders for excipients or process aids
  • API suppliers tied to DMFs and ANDA/505(b)(2) dossiers
  • Wholesale distributor listings by NDC and labeler

“LO-MALMOREDE” must first be resolved to an NDC/labeler or marketing authorization holder.

What is the Orange Book status of LO-MALMOREDE (NDA, ANDA, exclusivity)?

Featured snippet answer: Cannot be determined from the provided name.

What is required for Orange Book lookup-grade results

  • Correct proprietary name and active ingredient
  • NDA/BLA number or at minimum the exact FDA-listed proprietary name spelling
  • Dosage form and strength

Which manufacturers make LO-MALMOREDE finished dosage forms (tablet, capsule, liquid, injection)?

Featured snippet answer: Not determinable from the provided identifier.

Common manufacturing intelligence sources (only after product resolution)

  • FDA Establishment Registration and Drug Listing (DERP)
  • Site-level manufacturing data from NDA/ANDA chemistry and controls sections
  • GMP inspection records tied to the labeler’s manufacturing sites

Do any patent estates or Paragraph IV challenges affect LO-MALMOREDE supply?

Featured snippet answer: Cannot be evaluated without an active ingredient and reference product.

Why supplier mapping depends on product identity

Patent status drives:

  • Which ANDAs can launch
  • Which manufacturers are contractually tied to a platform or settlement
  • Whether supply depends on authorized generics, exclusivity blockers, or licensing

Key Takeaways

  • A supplier and manufacturer list for “LO-MALMOREDE” cannot be produced without resolving the name to a unique active ingredient, dosage form, and regulatory reference product.
  • Any attempt to list companies, APIs, or manufacturing sites from this identifier alone would not meet high-stakes patent and regulatory analysis standards.

FAQs

  1. What does LO-MALMOREDE correspond to (active ingredient and reference product)?
  2. How do I find the FDA NDC labeler for a drug name if the spelling varies?
  3. Where can finished dosage manufacturers be verified besides the label?
  4. How are API suppliers identified when the drug is marketed under a different proprietary name?
  5. What data sources best connect ANDA filings to API and formulation manufacturers?

References

No sources cited because the drug identity required for citation-grade supplier mapping is not provided.

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