DINOPROSTONE: Pharmaceutical manufacturers, suppliers, and packagers

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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

Last updated: May 26, 2026

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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