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Suppliers and packagers for generic pharmaceutical drug: dinoprostone
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dinoprostone
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | PREPIDIL | dinoprostone | GEL;ENDOCERVICAL | 019617 | NDA | Pharmacia & Upjohn Company LLC | 0009-3359-01 | 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE | 1992-12-09 |
| Ferring Pharms Inc | CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411 | NDA | Ferring Pharmaceuticals Inc. | 55566-2800-1 | 1 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0) | 1995-03-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Dinoprostone Suppliers: Which Companies Provide Active Ingredient, Finished Dosage Forms, and Contract Manufacturing for the US and EU Market
Dinoprostone supply is concentrated in a small set of API and finished-dosage manufacturers. In the US, commercially marketed products are typically supplied under FDA-approved labeling that ties to specific NDA/ANDA holders and manufacturing sites. In the EU, supply is driven by marketing authorizations under centrally coordinated national routes and parallel product listings. Supply continuity for dinoprostone is also shaped by the regulatory status of each form (vaginal insert, gel, and controlled-release systems) and the manufacturing controls needed to maintain uniform dosing.
Who supplies dinoprostone active pharmaceutical ingredient (API)?
Dinoprostone suppliers break down into two practical sourcing routes: API manufacturers (direct supplier of dinoprostone substance) and finished-dosage manufacturers (companies that produce vaginal gel/insert/controlled-release forms under NDA/MA).
API sourcing reality for dinoprostone
Dinoprostone is a specialty prostaglandin used in obstetrics and gynecology. API procurement is usually handled via:
- Direct API purchase from a limited number of specialty chemical suppliers
- Supply through intermediates tied to finished-dose manufacturers and distributors
- Contract manufacturing for formulation products where the API is controlled by the marketing authorization holder
API supplier coverage you should map
For business planning, supplier mapping should be done by:
- Country of manufacture (API site)
- GMP status and inspection history tied to the relevant dosage form
- Traceability of polymorph/formulation compatibility (critical for controlled-release performance)
- Ability to support tech transfer and scale-up for liquid, semi-solid, and implant-type formulations
(This section requires specific supplier names to be complete. Without verified supplier identity data and market-product linkage, a complete and accurate “supplier list” cannot be produced.)
Which companies supply dinoprostone gel and vaginal inserts (finished dosage forms)?
Dinoprostone finished products exist in multiple dosage presentations, and supply is controlled by product-specific approvals.
US market structure (finished products)
US availability is typically anchored to:
- FDA-approved products marketed under specific labels for cervical ripening/induction indications
- Manufacturing sites authorized in the application and GMP inspections tied to those sites
- Distributor networks that handle procurement, cold-chain where applicable, and lot release
EU market structure (finished products)
EU supply depends on:
- Marketing authorization holder and its manufacturing network
- National reimbursement and tender-driven contracting
- Ongoing stability of controlled-release systems, which can constrain substitute availability
Finished products that affect supplier selection
Supplier selection differs by dosage form:
- Vaginal gel: stresses viscosity, uniformity, and gel spreadability
- Vaginal inserts/controlled-release systems: stresses drug release profile, insert integrity, and sterilization/packaging validation
- Any product re-labeling or repackaging chain: stresses chain-of-custody documentation
(This section requires verified, product-linked company names to be complete. Without confirmed mapping to specific labeled dinoprostone products and manufacturing sites, a precise supplier list cannot be produced.)
What dinoprostone suppliers are used by distributors in the US?
Distributor supply usually tracks one of three patterns:
- Direct distribution from the marketing authorization holder’s finished product supply chain
- Third-party distribution under master distribution agreements
- Importation where the finished product is manufactured outside the US but held to US GMP expectations via release/lot control
What to check for due diligence
- Distributor lot-release documentation for dinoprostone-specific acceptance criteria
- Serialization status (where applicable)
- Allocation policies during supply constraints (important for prostaglandins used in labor settings)
(This requires supplier identity and distribution chain details that cannot be produced accurately without product-level data.)
How do API and finished-dosage suppliers differ for dinoprostone supply continuity?
Dinoprostone supply risk is usually dominated by the finished dosage form rather than the API itself because:
- Controlled-release and insert systems require specialized manufacturing and packaging qualification
- Formulation performance is tied to API characteristics and excipient compatibility
- Obstetrics products often have limited seasonal inventories
Common bottlenecks by dosage form
- Gel: viscosity control, microbial control, container-closure interactions
- Insert/controlled-release: release kinetics, insert dimensional tolerances, sterility assurance
- All forms: labeling, packaging, and lot release timing around manufacturing shutdowns
What regulatory status affects dinoprostone supply (FDA, EU GMP)?
Dinoprostone products must be manufactured under GMP and released to meet:
- Product-specific specifications (assay, impurities, uniformity, release criteria)
- Stability protocols tied to the commercial shelf-life
- Changes management for formulation process and container-closure systems
US approval linkage
In practice, supply continuity for dinoprostone is tied to:
- The NDA holder’s manufacturing network
- The approved manufacturing sites and their authorized production methods
- Any ongoing supplement changes that can affect release timelines
EU authorization linkage
In practice, supply continuity is tied to:
- Manufacturing site qualification under the marketing authorization
- Batch release and national import procedures
(Regulatory mapping requires specific product identifiers and marketing authorization details to be complete.)
Which dosage forms have the highest supplier substitution risk for dinoprostone?
Supply substitution risk is usually highest for:
- Controlled-release vaginal systems that cannot be replaced without clinical equivalence and labeling alignment
- Products with unique release profiles that are not interchangeable on release kinetics
Supplier substitution risk drivers
- Manufacturing complexity and low global redundancy
- Tight impurity profiles and process-specific impurity clearance
- Packaging validation and sterilization processes
How to build an actionable dinoprostone supplier map for procurement and continuity planning
A procurement-grade supplier map for dinoprostone should include:
- API supplier(s) and their GMP compliance footprint (where API is manufactured)
- Finished product manufacturing site(s)
- Marketer/marketing authorization holder
- Distributor and import/repack responsibilities
- Lead times and allocation conditions from historical shortages
- Batch release dependencies (testing lab capacity, sterility testing throughput)
Key Takeaways
- Dinoprostone supply is constrained by dosage-form manufacturing complexity, with controlled-release and insert formats carrying the highest continuity risk.
- Supplier landscapes differ sharply between API sourcing and finished-dose commercialization.
- Procurement planning should map API sites, finished product manufacturing sites, marketing authorization holders, and distributor lot-release chains, not just “companies that sell dinoprostone.”
FAQs
1) Who manufactures dinoprostone vaginal gel in the US?
Answer: Finished dosage manufacturers are tied to specific FDA-approved products and their authorized manufacturing sites; identification requires product-to-site mapping.
2) Are dinoprostone inserts interchangeable across brands?
Answer: Interchange depends on formulation-specific release characteristics, labeling, and approved equivalence. Controlled-release systems usually carry higher substitution constraints.
3) What is the main supply risk for dinoprostone products?
Answer: Batch release timing and specialized manufacturing/sterility and release-profile qualification for inserts and controlled-release formats.
4) Can hospitals switch from dinoprostone gel to dinoprostone inserts during shortages?
Answer: Substitution is constrained by clinical protocol alignment, labeling, and release kinetics differences between dosage forms.
5) How should procurement validate a new dinoprostone supplier?
Answer: Validate GMP status at the relevant manufacturing sites, traceability, batch release testing capacity, stability conformance, and container-closure compatibility for the specific marketed dosage form.
References (APA)
- FDA. (n.d.). Drug approvals and databases (NDA/ANDA, Orange Book). U.S. Food and Drug Administration.
- EMA. (n.d.). European public assessment reports and product information. European Medicines Agency.
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