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Rilmenidine Hydrogen Phosphate API

Cas Number : 85409-38-7
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Regulatory Documentation
ASMF
Category
Commercially available/Generic APIs
Rilmenidine

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About Rilmenidine Hydrogen Phosphate API

Rilmenidine Hydrogen Phosphate API is manufactured in Minakem’ French facility in Beuvry-la-foret for more than 10 years.
Rilmenidine Hydrogen Phosphate API CAS Number is 85409-38-7

From a regulatory perspective, Minakem offers:

  • An ASMF
  • A European DMF (CEP) expected in 2026 (Pharmacopea under evaluation).

Therapeutical Class and Mechanism of Action

Rilmenidine API is an antihypertensive agent classified as a centrally acting antihypertensive drug. It belongs to the class of imidazoline receptor agonists.
Rilmenidine works by selectively binding to imidazoline I1 receptors in the brainstem, which play a critical role in regulating sympathetic nervous system activity. Its mechanism involves the following:

  • Reduction in Sympathetic Nervous System Activity that leads to a reduction in heart rate and vascular resistance.
  • Lowering of Blood Pressure
  • Selective Action: Unlike older generation of antihypertensive drugs (e.g., clonidine), rilmenidine has low affinity for alpha-2 adrenergic receptors, which reduces its sedative and dry-mouth side effects

Rilmenidine is primarily prescribed for the management of essential hypertension and offers a favorable side effect profile due to its selectivity for imidazoline receptors.

About Minakem Beuvry-la-Forêt’s Expertise

Minakem Beuvry-la-Forêt was the first site acquired by Minafin (formerly SEAC) in 2005.
The site has extensive expertise in R&D and analytical development and has been manufacturing Active Pharmaceutical Ingredients (APIs) for over 20 years.

In 2023, a significant investment of 35 million EUR was made to enhance its competitiveness in API manufacturing and to improve its HSE ranking through the implementation of a modern COV (Volatile Organic Components) reduction system.

The site specializes in low-temperature chemistry (e.g., Suzuki coupling, lithiation), cyanuration, bromination, hydrogenation, and more. Additionally, it excels in solid engineering design, enabling the efficient management of polymorphism and particle size distribution (PSD).

Strategically located in the heart of Europe, between Lille, Paris, and Brussels, the site exports 90% of its production globally.

About Minakem’s Network

Minakem Beuvry-la-Forêt 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

Rilmenidine Hydrogen Phosphate API additional data are available on

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Get in touch Rilmenidine Hydrogen Phosphate API

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api@minakem.com