Rilpivirine free base (injectable) Sterile API

Cas Number : 500287-72-9
Regulatory Documentation
USDMF
Category
Generic APIs/Under development
Therapeutical Use
HIV Infection Treatment
Rilpivirine

By clicking on the molecule you can move it.

About 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 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

Rilpivirine free base (injectable) Sterile API’s data are available on

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Rilpivirine free base (injectable) Sterile API additional data are available on

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