Suppliers and packagers for PROSTIN VR PEDIATRIC

PROSTIN VR PEDIATRIC

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	PROSTIN VR PEDIATRIC	alprostadil	INJECTABLE;INJECTION	018484	NDA	Pharmacia & Upjohn Company LLC	0009-0215-05	5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01)	2022-10-03
Pfizer	PROSTIN VR PEDIATRIC	alprostadil	INJECTABLE;INJECTION	018484	NDA	Pharmacia & Upjohn Company LLC	0009-3169-06	5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01)	1981-10-16

Suppliers for PROSTIN VR PEDIATRIC (alprostadil): key manufacturers, sourcing structure, and IP-relevant supply constraints

Last updated: May 29, 2026

PROSTIN VR PEDIATRIC is a U.S.-market pediatric formulation of alprostadil (prostaglandin E1). Suppliers in practice split into (1) the labeled drug product manufacturer(s) and (2) upstream suppliers of alprostadil drug substance and formulation components that support contracted manufacturing. The tightest supply bottlenecks typically come from drug substance (alprostadil) and sterile manufacturing capacity for the ready-to-use pediatric product.

Who supplies PROSTIN VR PEDIATRIC in the US market?

Answer: The labeled product is supplied by the current U.S. holder/manufacturer listed for PROSTIN VR PEDIATRIC in FDA labeling and the FDA drug listing systems. The upstream drug-substance supply comes from specialized manufacturers of prostaglandin E1 (alprostadil), with sterile dose-manufacturing executed under GMP by the commercial drug-product site(s).

What is the supply chain structure for alprostadil pediatric prostaglandin E1?

• Drug substance (API) supply: prostaglandin E1 (alprostadil) API manufacturer(s).
• Drug product manufacturing: GMP sterile manufacturing and packaging of PROSTIN VR PEDIATRIC.
• Distribution and market supply: wholesaler network and specialty distribution to hospitals/cardiology units.

How to map “supplier” to enforceable commercial relationships?

For procurement and contracting, “supplier” usually means the entity that:

1. holds the FDA drug listing for the marketed product,
2. signs the supply agreement for the U.S. commercial product, and
3. supports the supply chain with API procurement and sterile fill-finish capacity.

What companies manufacture the PROSTIN VR PEDIATRIC drug product?

Answer: Labeled drug product manufacturing for PROSTIN VR PEDIATRIC is determined by the FDA label “Manufactured for/Manufactured by” line for the marketed product and the associated NDA/BLA labeling history.

Where do “manufactured by” lines appear in practice?

• U.S. prescribing information (PDF label package)
• FDA structured labeling records
• Package labels on distributed product

How many drug-product sites typically support sterile prostaglandin products?

Usually one to two primary sterile sites, with secondary sites limited to lifecycle supplements and stability-driven shifts.

Who supplies alprostadil (prostaglandin E1) API for PROSTIN VR PEDIATRIC?

Answer: The API supplier set is determined by (1) the labeled drug’s NDA chemistry and manufacturing descriptions and (2) commercial GMP supply arrangements for alprostadil production.

What upstream constraints affect alprostadil API supply?

• Scarcity of specialized prostaglandin E1 synthesis capacity
• Limited secondary-source availability due to tight impurity profiles and crystallization/solvent handling controls
• Sterile compatibility requirements downstream (trace levels of impurities matter)

Are there contract manufacturing organizations (CMOs) supporting PROSTIN VR PEDIATRIC?

Answer: If the drug-product label indicates “Manufactured by” and the site is not the marketing-authority company, the label points to the CMO/contract site. Many sterile injectables use dedicated fill-finish and packaging lines under CMO arrangements.

How to identify CMO involvement quickly

• The label “Manufactured by” name and address
• FDA establishment registration data tied to the listed product
• Sanctioned inspection histories for sterile injectable facilities (as relevant to continuity of supply)

What excipients, sterile components, and packaging suppliers matter for PROSTIN VR PEDIATRIC?

Answer: For procurement risk, the critical inputs are sterile-contact components and packaging that must preserve prostaglandin integrity:

• sterile formulation excipients (buffering/solubilizers as specified in label)
• sterilizable container closure system (often glass and elastomer considerations)
• packaging components that meet cold-chain and light-protection requirements where specified

How formulation design influences supplier replacement risk

• Container closure compatibility and extractables/leachables
• Sterile filtration or aseptic handling compatibility
• Stability under transport conditions

Which supply partners matter for hospitals buying PROSTIN VR PEDIATRIC?

Answer: Hospitals typically transact through:

1. the U.S. marketing authorization holder’s distribution channels and
2. contracted specialty distributors/wholesalers.

What procurement channels create the shortest lead times?

• Direct hospital contract with the labeled product supplier
• Specialty distributor stocking programs
• Limited “emergency” allocations if supply is constrained

What supply risk signals affect PROSTIN VR PEDIATRIC availability?

Answer: Supply disruptions for prostaglandin injectables most often come from sterile manufacturing bottlenecks, API batch failures, or regulatory/quality events at key facilities.

How to monitor supply continuity (operational indicators)

• FDA/partner public shortage communications
• GMP warning letters or Consent Decrees tied to sterile sites
• Manufacturing capacity limits for aseptic filling lines
• API supply chain volatility from key prostaglandin suppliers

Key takeaways

• “Suppliers for PROSTIN VR PEDIATRIC” maps to the labeled drug-product manufacturer plus the API and component supply base supporting sterile manufacture.
• In practice, the most decision-relevant suppliers are the entities named in the FDA label manufacturing statements and the API producer set that underpins alprostadil (prostaglandin E1) drug substance supply.
• Supply continuity risk concentrates around sterile fill-finish capacity and alprostadil API batch reliability.

FAQs

1. How do I identify the manufacturing supplier for PROSTIN VR PEDIATRIC from FDA records?
   Use the current prescribing information label “Manufactured by/Manufactured for” line for the U.S.-market product.

2. What upstream inputs most affect alprostadil availability?
   Alprostadil API synthesis capacity and sterile injectable formulation/packaging compatibility.

3. Can multiple manufacturers supply the same PROSTIN VR PEDIATRIC strength?
   Yes when different GMP sites are qualified for the same marketing authorization, but the label manufacturing statement is the authoritative guide.

4. What happens to hospital supply during sterile manufacturing constraints?
   Allocations typically shift to the most qualified distribution channel and stocked SKU lots from the running site.

5. What indicators best predict shortages for prostaglandin injectable products?
   Sterile site capacity constraints, API batch quality failures, and any regulatory actions impacting the key manufacturing establishments.

References

1. FDA. Drug Labeling for PROSTIN VR PEDIATRIC (alprostadil). U.S. Food and Drug Administration.
2. FDA. Drug Shortages Database. U.S. Food and Drug Administration.
3. FDA. NDC Directory and Structured Product Labeling (SPL). U.S. Food and Drug Administration.
4. FDA. Center for Drug Evaluation and Research (CDER). Product quality and facility information sources.