Last updated: June 1, 2026
DIVIGEL is estradiol gel sold in the US under ANI Pharmaceuticals’ label. Supply is typically handled through contract manufacturing and controlled distribution for hormone products, with product-specific packaging and labeling execution tracked to the NDA and label/DSU filing. A complete “supplier” map (site-by-site, company-by-company for drug substance, drug product, packaging, and logistics) requires NDA/CMC disclosure plus FDA product listings and commercial supply-chain data.
Who supplies DIVIGEL drug product and label distribution in the US?
Answer: The US listed label holder is ANI Pharmaceuticals, Inc.; the actual manufacturing and packaging are handled by one or more contract manufacturing organizations tied to the NDA and reviewed CMC packages.
For US supply-chain mapping, the authoritative sources are (1) FDA’s NDC Directory / Drug Labeling records and (2) the NDA’s listed facilities for drug product manufacturing, packaging/labeling, and (when applicable) sterile vs. non-sterile controls. DIVIGEL is a topical non-sterile dosage form (gel), so facility relevance is primarily for blending, filling into pump/foil laminate components or sachet systems (depending on presentation), and packaging/labeling.
DIVIGEL commercial label holder and regulatory gatekeeper
- Marketing authorization (US NDA label holder): ANI Pharmaceuticals, Inc.
- Product type: topical estradiol gel (estrogen replacement therapy)
Which companies manufacture DIVIGEL gel under contract manufacturing arrangements?
Answer: Contract manufacturing is the norm for topical hormone gels; exact manufacturer identities must be taken from the FDA/NDA facility listings tied to each NDC.
A supplier list that holds up for licensing, procurement, or litigation needs to enumerate:
- Drug product manufacturing site(s) (gel preparation and filling)
- Primary packaging supplier (pump actuator components, vial/jar/sachet materials)
- Secondary packaging and labeling facility
- Distribution/wholesaler network where DSCSA traceability is relevant
Without the specific NDC(s) and the corresponding FDA facility history, a supplier roster cannot be accurately enumerated to company and site.
What Orange Book and patent constraints affect DIVIGEL supply continuity?
Answer: DIVIGEL’s supply constraints in the US flow from the branded NDA exclusivity and Orange Book–listed patents, plus any approved generic/AB-rating and litigation outcomes.
Key points for supply risk:
- If an Orange Book-listed patent is still in force, generic entry can be blocked or delayed even when manufacturing capacity exists.
- For topical estrogen products, patent strategy often covers formulations, manufacturing process details, and method-of-use.
A complete constraint analysis requires the Orange Book listing for DIVIGEL’s active moiety and strength(s), including:
- Patent numbers, expiration dates, and patent types
- Exclusivity periods tied to the NDA
- Any Paragraph IV history that triggered stays or settlements
Are there generic or authorized-OTC equivalents competing with DIVIGEL that change the supplier landscape?
Answer: When FDA approvals exist for estradiol gel AB-rated products, the supplier landscape changes through additional manufacturers and packagers; the extent depends on each approved product’s NDC-level facility list and packaging configuration.
In practice, many “estradiol gel” market entrants share:
- The same active (17β-estradiol)
- Different strengths (commonly mapped to mg/day dosing)
- Distinct delivery systems (dose meters, pump types, sachet formats)
Supplier mapping is NDC-specific. Without the NDC-level data, a firm supplier count and identity list cannot be provided.
What supplier categories matter most for procurement of DIVIGEL?
Answer: For a topical gel branded like DIVIGEL, procurement due diligence should focus on NDA-linked manufacturing sites, packaging/labeling facilities, and DSCSA-compliant distribution.
Procurement-relevant supplier categories:
- API and drug substance sourcing (17β-estradiol synthesis and purification)
- Drug product manufacturing (gel blending, filtration if applicable, dose calibration)
- Filling and packaging system suppliers (container, pump/sachet, dose metering components)
- Packaging and labeling (carton printing, lot control, NDC imprinting)
- Regulatory compliance and quality systems (GMP status by site, audit history)
- DSCSA traceability and distribution (authorized trading partners and serialization/traceability interfaces)
How do FDA inspections and CMC changes typically impact DIVIGEL supply?
Answer: Supply interruptions often follow CMC change control, site qualification updates, stability excursions, or GMP observations tied to the manufacturing or packaging facility used for a given NDC.
High-impact triggers for topical gel products:
- Process changes in gel formulation or mixing equipment
- Changes to container closure system components
- Packaging component substitutions (pump, actuator, seals)
- Stability or shipping condition performance
- Label revision or packaging line relocation
Key Takeaways
- The US label holder for DIVIGEL is ANI Pharmaceuticals, Inc., but the actual gel manufacturing and packaging suppliers are defined at the NDC/facility level within FDA NDA listings.
- A credible “supplier list” for DIVIGEL must be built from FDA facility entries tied to the product’s NDC(s) plus NDA CMC disclosures; generic supply risk is driven by Orange Book/patent and exclusivity status.
- For procurement, due diligence should focus on NDA-linked manufacturers and packagers, and DSCSA-compliant distribution, because these determine continuity and substitution risk.
FAQs
1) What does ANI Pharmaceuticals’ role mean for DIVIGEL manufacturing?
ANI is the US marketing authorization holder; manufacturing and packaging are performed at FDA-listed GMP facilities for the product’s NDC.
2) How do I identify the actual DIVIGEL manufacturing site?
Use the product’s NDC to pull FDA listing data for the corresponding manufacturing/packaging facilities tied to the NDA.
3) Do DIVIGEL’s estradiol gel patents affect who can supply it?
Yes. Orange Book-listed patents and any exclusivity periods can restrict generic competition and alter supplier mix.
4) What DSCSA elements affect DIVIGEL sourcing and traceability?
Supplier qualification must cover authorized trading partners and product-level traceability/serialization workflows required for DSCSA transactions.
5) Can the same supplier make multiple estradiol gel brands?
Often yes at the CMO level, but NDC-specific packaging, label, and CMC controls make site and lot traceability product-specific.
References
- FDA. “NDC Directory.” U.S. Food and Drug Administration.
- FDA. “Drug Approvals and Databases: Orange Book.” U.S. Food and Drug Administration.
- FDA. “Drug Labeling (Drugs@FDA).” U.S. Food and Drug Administration.
