Fluorescein base & sodium API (ophthalmics BFS)

Cas Number : 2321-07-5
Regulatory Documentation
CEP/JDMF/USDMF
Category
Commercially available/Generic APIs
Fluorescein

By clicking on the molecule you can move it.

About Fluorescein base & sodium API (ophthalmics BFS)

Fluorescein API has been developed at Minakem’s Canadian facility (Delmar Chemicals Inc.).

It is available in two forms: the base (commonly used) and the sodium salt.
Fluorescein base API CAS number is 2321-07-5
Fluorescein sodium salt CAS number is 518-47-8

From a regulatory perspective, Minakem offers for Fluorescein Base:

  • An American DMF (Drug Master File) #30633
  • A Japanese DMF
  • An Autralian DMF
  • A New Zealand DMF

From a regulatory perspective, Minakem offers for Fluorescein Sodium Salt:

  • A European ASMF (Spain)

Minakem’s Fluorescein API brings:

  • Dedicated workshop
  • Safety stock available
  • High quality product required by sterile ophthalmics BFS technology

Therapeutical Class and Mechanism of Action

Fluorescein API is a dye medication used to visualize blood vessels in the eye.

As an ocular disclosing agent, fluorescein sodium readily dissolves in aqueous alkaline solutions, absorbs light at 465 to 490 nm (cobalt blue light), and fluoresces bright green at 520 to 530 nm.

The FDA has also approved fluorescein for use in externally applied drugs and cosmetics (Source: Merck Index, 12th ed.; American Medical Association Drug Evaluations, 1995, p. 2275).

About Minakem Montreal’s Expertise

Minakem Montreal (Delmar chemicals Inc.) has been manufacturing Active Pharmaceutical Ingredients (APIs) since 1941.
It is the largest API facility in Canada, benefiting from a strong scientific and technological environment.

Located close to its U.S. customers in the New Jersey and Boston areas, Montreal also has a strong tradition of serving the entire North American market, as well as Latin America, Europe, Japan, China, and India.

About Minakem’s Network

Minakem Montreal collaborates daily with Minakem’s other European facilities, leveraging their complementary expertises in solid engineering, analytics, global regulatory affairs, and other capabilities to enhance competitiveness.

Minakem brings over 40 years of experience in developing, scaling up, registering Drug Master Files (DMFs), and manufacturing complex Active Pharmaceutical Ingredients (APIs), including chiral small molecules, steroids, and highly potent APIs (HPAPIs)—primarily used in oncology treatments.

As supply chain performance becomes increasingly critical to customers’ success, Minakem focuses on delivering:

  • Safe products for patients,
  • High On-Time-In-Full (OTIF) performance,
  • Robust quality support, and
  • Innovative solutions to address customers’ unexpected market demands.

More data

Fluorescein base & sodium API (ophthalmics BFS)’s data are available on

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Fluorescein base & sodium API (ophthalmics BFS) additional data are available on

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