Last Updated: August 8, 2026

Suppliers and packagers for ZITUVIMET XR


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ZITUVIMET XR

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Pharmaceuticals USA Inc. 70710-1804-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Pharmaceuticals USA Inc. 70710-1805-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1805-6) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Pharmaceuticals USA Inc. 70710-1806-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1806-3) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA AUTHORIZED GENERIC Zydus Pharmaceuticals USA Inc. 70710-2036-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2036-6) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA AUTHORIZED GENERIC Zydus Pharmaceuticals USA Inc. 70710-2037-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2037-6) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA AUTHORIZED GENERIC Zydus Pharmaceuticals USA Inc. 70710-2038-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2038-3) 2024-10-31
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Lifesciences Limited 70771-1879-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1879-6) 2024-10-31
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for ZITUVIMET XR

Last updated: May 29, 2026

ZITUVIMET XR Suppliers: Active Ingredient, Contract Manufacturer, and Supply Chain Mapping

ZITUVIMET XR’s supplier landscape cannot be enumerated from the information provided. No drug-specific supplier list (API manufacturers, contract manufacturing organizations, packaging vendors, or distributor networks) is available in the prompt, and a complete, accurate supplier mapping requires item-level sourcing and regulatory or corporate sourcing records that are not included.

What suppliers make ZITUVIMET XR active ingredient and finished dosage form?

No supplier roster is provided for ZITUVIMET XR. Without product-label, FDA registration/inspection data, or Orange Book and establishment-level sourcing records, supplier identification for:

  • API (active pharmaceutical ingredient) manufacture
  • finished dosage form (extended-release tablet) manufacture
  • packaging and labeling cannot be produced accurately.

API supply chain details

  • API manufacturer name(s)
  • API intermediates and grade specifications
  • polymorph/particle size controls for XR performance
  • quality agreement structure are not included.

Finished-dose manufacturing details

  • contract manufacturing organization (CMO) identity
  • manufacturing sites and product lines
  • tablet compression, coating, and controlled-release layer processes
  • batch sizes and release testing labs are not included.

Packaging and distribution details

  • bottle/blister vendor(s)
  • labeler and secondary packaging parties
  • wholesaler/distributor network are not included.

Which contract manufacturers produce ZITUVIMET XR tablets?

No CMO identity, site mapping, or manufacturing role breakdown is provided for ZITUVIMET XR. A supplier answer requires at least one of the following: FDA establishment registrations tied to ZITUVIMET XR, labeler/holder-linked manufacturing statements, or verified corporate supply agreements.

What to typically extract for XR tablet CMOs

  • manufacturing establishment identifiers (FDA establishment numbers)
  • dosage form and strength per site
  • inspection history and compliance outcomes
  • change-control history affecting release or stability None of these data points are present.

What are the Orange Book-listed manufacturing and drug substance suppliers for ZITUVIMET XR?

No Orange Book entry details are provided for ZITUVIMET XR, and no list of listed drug (RLD) manufacturers, NDA/ANDA holders, or patent-protected manufacturing processes is included. Without an Orange Book listing, supplier identification tied to listed-drug ownership and establishment scope cannot be performed.

Who supplies ZITUVIMET XR excipients for extended-release performance?

No formulation supplier data is provided for excipients typically critical to XR performance (controlled-release polymers, film coatings, porosity modifiers, and tablet-binding systems). Supplier mapping for excipients requires:

  • validated formulation composition
  • supplier-of-record documentation or procurement disclosures
  • change notifications that name vendors None of that is included.

How do ZITUVIMET XR supply chain risks (single-source API, shortage, quality) affect availability?

No supply chain structure, sourcing redundancy, or shortage history is provided for ZITUVIMET XR. A risk assessment would require at minimum:

  • number of qualified API sources
  • site count and regulatory status of manufacturing facilities
  • known quality events or FDA warning letters tied to the product
  • historical discontinuations or NDC-level supply disruptions These data are not provided.

What generics or parallel products use the same suppliers as ZITUVIMET XR?

No NDC-level crosswalk, AB-rated product set, or ANDA/RLD manufacturing linkage is provided for ZITUVIMET XR. Without:

  • RLD identification
  • ANDA applicants tied to the same drug substance and process
  • shared CMO or API vendor links no accurate supplier convergence mapping can be produced.

Which regions depend on which ZITUVIMET XR distributors and importers?

No country-level distributor or importer roster is provided. A regional supplier answer requires:

  • NDC distribution channel details (US wholesalers or direct ship)
  • importer of record details for specific markets
  • contracts or licensee documents naming regional distributors None of this is included.

Key Takeaways

  • A verified supplier list for ZITUVIMET XR (API, CMO, packaging, labeling, and distribution) is not available in the provided information.
  • Supplier mapping requires product-specific regulatory and establishment sourcing records that are not included here.

FAQs

  1. Who is the API supplier for ZITUVIMET XR?
    Not provided in the input.

  2. Which CMO manufactures ZITUVIMET XR tablets?
    Not provided in the input.

  3. Is ZITUVIMET XR manufactured by multiple sites or a single facility?
    Not provided in the input.

  4. What contract packaging vendors produce ZITUVIMET XR blister or bottles?
    Not provided in the input.

  5. Do ZITUVIMET XR generics use the same API and manufacturing suppliers?
    Not provided in the input.

References

(No cited sources provided in the input.)

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