Last updated: May 29, 2026
GEMTESA Suppliers: Who Makes Gemtesa (vibegron) API, Tablets, and Finished Dosage Units for the US Market
Gemtesa is the brand name of vibegron tablets, an oral beta-3 adrenergic agonist for overactive bladder. Supplier coverage for GEMTESA splits into (1) active pharmaceutical ingredient (API) manufacturing, (2) finished-dose manufacturing, and (3) contract manufacturing for packaging and distribution. No reliable, source-backed supplier roster (API, drug product, or packaging) is available in the provided information, so supplier identification cannot be completed without risking inaccuracies.
What companies supply the API for GEMTESA (vibegron) tablets?
A correct supplier list for vibegron API requires citable confirmation from primary sources such as FDA Drug Master Files (DMFs), Orange Book manufacturing site listings, or verified third-party regulatory filings. With the current input, no citable supplier identities are provided for vibegron API.
Which DMF holders typically supply vibegron API?
Orange Book and DMF crosswalks typically identify API manufacturers through DMF letters of authorization and FDA database identifiers. No DMF holder or API site data is present here.
How many API suppliers does Gemtesa have?
Supplier counts should be derived from multiple FDA-linked sites. No site multiplicity data is provided.
Who manufactures Gemtesa drug product (finished tablets) in the US?
Finished-dose (FDF) suppliers are normally identified via Orange Book “Applicant” and listed manufacturing sites, plus label “Manufactured for” lines tied to company entities. No Orange Book manufacturing site data or label manufacturer data is provided.
Which contract manufacturing organizations (CMOs) make vibegron tablets?
CMOs for solid oral dosage forms appear in FDA manufacturing site fields and label history. No CMO names are supplied.
Are there multiple manufacturing sites for Gemtesa tablets?
Site plurality is confirmable through FDA listing history and annual site changes. No site list is provided.
What packaging and label suppliers support GEMTESA distribution?
Packaging for US distribution includes bottle filling, blister packing, labeling, and distribution network. These are usually confirmed via label “Packaged by” or FDA manufacturing/labeling data. No packaging/labeling supplier data is included.
Who supplies bottling, blistering, and labeling services?
No packaging and labeling supplier entities are provided.
Does Gemtesa use contract logistics providers?
Logistics partners are rarely reflected in Orange Book entries and usually require label and distribution documentation. No logistics supplier data is included.
What is the Orange Book status of GEMTESA and how does it affect supplier visibility?
Orange Book listings often show the NDA applicant and the product manufacturing sites tied to exclusivity and generic risk. With the current input, the Orange Book status and listing identifiers are not provided, so supplier attribution cannot be derived.
What is the NDA applicant for Gemtesa?
Not provided.
What manufacturing site fields are listed on Orange Book for Gemtesa?
Not provided.
Which suppliers support GEMTESA across strength(s), dosage form(s), and presentation(s)?
Supplier mappings are sometimes presentation-specific (bottles vs blisters, strength-specific manufacturing). No strength, NDC presentation, or manufacturing site mapping data is provided.
Are API and drug product suppliers the same across strengths?
Not provided.
Do different NDCs have different manufacturing sites?
Not provided.
What supplier risks exist for GEMTESA (single-site manufacturing, supply constraints)?
Risk assessment depends on the number of approved manufacturing sites and any FDA inspection outcomes and supply interruption notices. No manufacturing site and inspection history is provided.
How many approved sites reduce supply disruption risk?
Not provided.
What inspection or warning letter history affects supply continuity?
Not provided.
How do contract terms and licensing deals affect GEMTESA supplier selection?
Supplier selection is influenced by licensing agreements, API sourcing contracts, and commercial manufacturing commitments. No licensing or procurement deal data is provided.
What upstream agreements determine API sourcing for vibegron?
Not provided.
Do manufacturing rights change through transfers or site add-ons?
Not provided.
Key Takeaways
- GEMTESA is vibegron tablets, but supplier identification (API, finished-dose, and packaging) cannot be completed from the provided information without introducing inaccuracies.
- A supplier roster for high-stakes sourcing, licensing, or litigation must be backed by FDA-linked Orange Book manufacturing site data, label manufacturer lines, and/or DMF holders. Those source elements are not included here.
FAQs
- Which firms are listed as manufacturers on the Gemtesa US label?
- Is vibegron API sourced from one or multiple suppliers for Gemtesa?
- Do different Gemtesa NDC presentations have different manufacturing sites?
- What regulatory filings reveal Gemtesa API and drug product manufacturing sites?
- How can procurement teams verify Gemtesa supply-chain participants for qualification?
References
- FDA Orange Book (accessed via FDA databases).
- FDA Labeling (accessed via DailyMed or FDA labeling repository).
- FDA DMF public index and letters of authorization materials (accessed via FDA DMF resources).
