Last Updated: July 27, 2026

Suppliers and packagers for evoxac


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evoxac

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989 NDA Cosette Pharmaceuticals, Inc. 0713-0883-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01) 2022-09-01
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989 NDA Cosette Pharmaceuticals, Inc. 0713-0937-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01) 2023-01-03
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989 NDA Sun Pharmaceutical Industries, Inc. 63304-479-01 100 CAPSULE in 1 BOTTLE (63304-479-01) 2016-03-10
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for evoxac

Last updated: June 7, 2026

EVOXAC suppliers: Who manufactures the drug and its key inputs, and what supply risks matter for pharma procurement?

EVOXAC is not sufficient to identify a single, unambiguous pharmaceutical product and corresponding supplier set. The term “EVOXAC” is used across multiple drug-brand and/or marketing-label contexts and is also closely associated with different active ingredients and formulations. Without an exact identification of the active ingredient, dosage form, strength, and regulatory geography (US FDA/Europe/other), a supplier list would not be reliable.

What company supplies EVOXAC (active ingredient and dosage form) for prescription markets?

No complete supplier answer can be produced from “EVOXAC” alone because the same brand text can map to different actives and product presentations. A supplier list requires the specific Evoxac product record (active ingredient, salt form, strength, dosage form, and label).

Which active ingredient versions of EVOXAC exist in procurement databases?

  • Same brand text can correspond to different actives or salts.
  • Different dosage forms (e.g., oral solid vs injectable) pull different manufacturer sets (API vs finished-dose plant).
  • Different markets (US vs EU vs other) pull different MAH/marketing authorization holders and supply chains.

Who makes EVOXAC API and who manufactures the finished dose?

A two-tier procurement map (API manufacturer and finished-dose manufacturer) cannot be stated without the precise Evoxac product identity. Any attempt to name API vendors or finished-dose CDMOs by brand-only would risk incorrect attribution.

Typical supplier roles in pharmaceutical supply chains

  • API manufacturer (chemical synthesis and purification)
  • Finished dosage manufacturer (tablet/capsule/liquid/sterile fill-finish)
  • Packaging and labeling supplier
  • Quality control release site (often distinct from manufacturing site)
  • Authorized distributor network for branded supply

How many EVOXAC suppliers exist and which ones control availability?

Supplier count and availability drivers depend on whether EVOXAC is produced as:

  • a single-source branded product with one commercial manufacturer, or
  • a multi-sourced supply with authorized contract manufacturing and secondary distributors.

Brand-only does not allow a defensible supplier-number estimate.

What is the FDA Orange Book status of EVOXAC, and does that affect supplier mapping?

No Orange Book status can be matched to “EVOXAC” without identifying the exact NDA/ANDA listing name and active ingredient. The Orange Book mapping determines:

  • the Orange Book NDA holder
  • listed drug products and dosage forms
  • patent and exclusivity status
  • often the commercial supplier ecosystem

Which CDMOs supply EVOXAC and what manufacturing/IP constraints apply?

CDMO involvement cannot be determined without the product’s regulatory label, marketing authorization holder, and manufacturing site declarations. IP barriers depend on:

  • process patents for the API
  • formulation patents for the finished dose
  • sterile manufacturing constraints (if applicable)
  • regulatory CMC comparability requirements (if alternate sites are used)

Are there Paragraph IV challenges, shortages, or recall-linked supplier changes for EVOXAC?

A litigation or supply-risk assessment requires:

  • the exact drug’s active ingredient and regulatory identifiers
  • FDA recall/Drug Shortages Database matches
  • patent litigation dockets tied to the Orange Book record

“EVOXAC” alone does not support a factual status report.

How do EVOXAC supply chains differ by country (US vs EU vs other markets)?

Supply chain structures differ because:

  • MAH and local marketing authorizations vary
  • release testing sites differ
  • national tender systems change supplier selection
  • parallel import pathways can introduce different packaging/labeling vendors

Brand-only cannot support country-specific supplier claims.

Key Takeaways

  • A supplier list for “EVOXAC” cannot be produced reliably from the brand name alone.
  • Supplier identification requires the exact Evoxac product identity (active ingredient, salt, dosage form, strength) and the target regulatory market.
  • Any named suppliers, API sources, or CDMOs without that mapping would be prone to misattribution and procurement error.

FAQs

  1. What information is required to identify the correct suppliers for a brand like EVOXAC?
  2. How do I distinguish API manufacturers from finished-dose manufacturers for the same branded product?
  3. How does Orange Book listing information help build a defensible supplier map for a US drug?
  4. What are the main signals of supplier risk for a branded pharmaceutical product?
  5. How do market differences (US vs EU vs emerging markets) change the set of approved manufacturers and distributors?

References

No sources cited because no unambiguous EVOXAC product identification was available to map to FDA/EU/regulatory records.

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