Rilpivirine free base (injectable) Sterile API

Rilpivirine free base (injectable) API was developed at Minakem’s Canadian facility (Delmar Chemicals Inc.) in 2024. Rilpivirine free base API has CAS Number 500287-72-9

From a regulatory perspective, Minakem offers:
– In 2025, an American DMF (Drug Master File) to be submitted

Minakem’s Rilpivirine free base API brings:
– polymorphism form II
– a selective granulometry (PSD) to facilitate your formulation
– High-quality production standards.

Therapeutical Class and Mechanism of Action
Rilpivirine free base API is is approved in combination with cabotegravir for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/ml).
This combo drug marketed by the originator under the brand name Rekambys. This medication improves significantly the patient wellness as it is a long-acting intramuscular injection to be given once every month or every two months

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 Rilpivirine free base API
Rilpivirine’s data are available on Pharmaoffer.

Rilpivirine additional data are available on Wikipedia