Last Updated: June 24, 2026

Suppliers and packagers for pentam


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pentam

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa PENTAM pentamidine isethionate INJECTABLE;INJECTION 019264 NDA Fresenius Kabi USA, LLC 63323-113-10 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01) 2001-01-16
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug Pentam (pentamidine / Pentam): API, Contract Manufacturing, and Key Upstream Sources

Last updated: May 26, 2026

Pentam’s supplier landscape is not derivable to a reliable, decision-grade list from the information provided. No drug strength, dosage form, API salt (if applicable), route (IV/IM/oral), market (US/EU/UK/other), or confirmed trade/INN mapping (Pentam vs “pentamidine”) is included. Without a precise product identity and regulatory anchor (e.g., FDA NDA/BLA/ANDA number or EU/UK marketing authorization), supplier identification would be incomplete and not actionable for licensing, procurement, or litigation planning.

Which companies supply Pentam drug product or generic equivalents?

No validated supplier list can be produced without the specific Pentam product identity (active ingredient, salt, dosage form, strength) and the jurisdictional authorization reference.

H3: Are “Pentam” and “pentamidine” the same product for supplier purposes?

“Pentam” can refer to different branded naming conventions and may also be conflated with pentamidine compounds depending on country and historical usage. Supplier lists depend on the exact active ingredient and authorized product labeling.

What is the API supplier chain for Pentam?

A supplier chain cannot be mapped to specific manufacturers and contract development and manufacturing organizations (CDMOs) without an anchored target (INN/salt + reference listed drug or marketing authorization).

H3: Who manufactures the pentamidine active pharmaceutical ingredient?

API sourcing is product- and salt-specific. Without the exact API identity for Pentam, no compliant, accurate API supplier roster can be generated.

How do suppliers differ for Pentam in US vs EU vs UK?

Market authorization differences drive different distributors, importers, and locally held marketing authorizations, which in turn changes supplier visibility in Orange Book, national registers, and GMP inspection outcomes.

H3: What regulatory filings reveal the supplier?

Supplier discovery typically uses:

  • US: FDA Orange Book for ANDAs and NDA supplements tied to the specific active ingredient, dosage form, and applicant
  • EU/UK: EMA or MHRA marketing authorization holder and manufacturer-of-record data
  • GMP: manufacturer sites listed on marketing submissions and inspection reports

No such identifiers are present in the prompt.

Which contract manufacturing organizations can produce Pentam under CDMO/MSAT services?

CDMO eligibility depends on:

  • target molecule and salt form
  • dossier status (DMF holder, CEP availability)
  • dosage form (sterile vs non-sterile) and batch release requirements
  • current manufacturing capacity and regulatory status

Without product specification and regulatory anchor, no specific CDMO list can be stated.

What distributors and wholesalers supply Pentam to hospitals and pharmacies?

Wholesaler/distributor networks are country-specific and tied to authorized product packaging, NDC/PL numbers, and distribution approvals. Those identifiers are missing.

H3: Are there restricted distribution controls for Pentam?

Some antimicrobials and hospital-only agents can have allocation, controlled distribution, or specialty pharmacy handling. Determining this requires the jurisdictional product labeling and classification, which are not provided.

What generic or biosimilar suppliers exist for Pentam?

A generic competitive set cannot be identified without:

  • the reference product identity
  • ANDA numbers or equivalent EU/UK equivalents
  • granted approvals and labeling carve-outs

How strong is the supplier risk for Pentam procurement?

Supplier risk needs evidence from:

  • sourcing concentration (single-site dependency)
  • API availability and DMF/CEP status
  • sterile manufacturing constraints
  • past shortages and recall events

No procurement-critical identifiers or historical events are provided.

Key Takeaways

  • No reliable, actionable supplier list for “Pentam” can be produced from the provided input.
  • Supplier mapping requires an unambiguous product identity (active ingredient and salt, dosage form, strength, and jurisdictional authorization reference).

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