LATEST NEWS

EMA

On March 13Th 2023, we have received from EMA: “Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorization for TEPADINA ®”. The Authorization:

1) B.II.b.2a (IA): to add ADIENNE S.r.l. (located at Via Galileo Galilei, 1920867 Caponago (MB) - Italy) as an alternative site responsible for quality control/testing of the finished product in addition to the current sites.

2) B.II.b.1z (II): to add ADIENNE S.r.l. (located at Via Galileo Galilei, 19 20867 Caponago (MB) - Italy) as an alternative site responsible for manufacturing of the finished product in addition to the current manufacturer.

Confirms that ADIENNE Srl Plant is Authorize to produce and test TEPADINA® Multichamber Flexible Bag for the EU Market.

AIFA GMP-API Authorization

ADIENNE is very proud to announce that, on March 14th 2023, we have received from AIFA GMP-API the new Authorization to produce:

API from Biological Process

Authorization is referred to our IMP product monoclonal antibody for the treatment of acute graft-versus-host diseases (aGvHD). The new Authorizations will open new possibility to the therapies in a specific field as the treatment of aGvHD.

AIFA Authorization

ADIENNE is very pleased and proud to announce that, on March 9th 2023, one year after our first AIFA Authorization, we have received our second AIFA Authorization for:

1) Lyophilized: Special Requirements Cytotoxic,Cytostatic

2) Small volume liquids

Authorization is referred to our new vials filling line. This Authorization will allow ADIENNE to start manufacturing activities for commercial batches for Cytotoxic and Cytostatic Products in different presentation vials.

AIFA Authorization

ADIENNE is very pleased to announce that, on April 5th 2022, AIFA authorized the ADIENNE’s manufacturing site in Caponago (MB – Italy) for commercial aseptic productions of:

1) Large Volume Liquids

2) Lyophilized: Special Requirements Cytotoxic Products, Cytostatics

3) Small Volume Liquids

This authorization will allow ADIENNE to start the manufacturing activities for commercial batched of its products in dual-chamber bags for its product TEPADINA 400mg and 200mg; it also opens new market horizons with the other products in our and CDMO pipe-lines.

MA extension for TEPADINA®

ADIENNE is very pleased to announce that on March 26th, 2021 the European Commission adopted an implementing decision concerning the granting of an extension of the marketing authorisation for TEPADINA®, which will be marketed also in a new strength as well as a new pharmaceutical form: 400mg in 400 ml bag, concentration 1 mg/ml, powder and solvent for solution for infusion. We are extremely proud to be the first company in the world obtaining a marketing authorisation for a cytotoxic product lyophilised directly in a ready-to-use bag – where both the underlying lyophilisation method and the bag are patented worldwide by us – thus marking an important step in the evolution of lyophilisation techniques.

The new ready-to-use system has been specifically designed to address all compliance issues associated with the reconstitution of cytotoxic drugs and meet the needs of pharmacists and nursing personnel for a safe and easy handling of the drug, avoiding the dangers posed by exposure to cytotoxic substances. Moreover, this innovative delivery system will soon enable cancer patients to be treated also outside care facilities and receive a safe and high quality healthcare at home.