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 works daily with Minakem’s other European facilities, leveraging their complementary expertise, such as solid engineering, analytics, global regulatory affairs, and capabilities to optimize competitiveness.
Minakem has over 40 years of expertise in developing, scaling up, registering DMFs, and manufacturing complex APIs, including chiral small molecules, steroids, and highly potent APIs (HPAPIs, primarily used in oncology treatments).
Strong supply chain performance is becoming critical to our customers’ success.
Minakem’s operations focus on producing safe products for patients, achieving high OTIF performance, providing strong quality support, and consistently seeking solutions to meet customers’ unexpected market demands.

More data on Fluorescein API
Fluorescein’s data are available on Pharmaoffer.

Fluorescein additional data are available on Wikipedia