Loading...
The Extrovis Group incorporates subsidiaries that span from research & development and manufacturing to regulatory approval. Our state-of-the-art manufacturing facilities ensure the production of high-quality pharmaceutical products that meet rigorous industry standards and comply with global regulatory requirements.
Our research and development centres are focused on creating solutions to address un/undermet needs of the healthcare professionals and patients around the world by delivering differentiated products, new dosage forms and complex APIs. To keep us at the forefront of innovation in pharmaceutical process and intellectual property development, Extrovis concurrently maintains strategy and development teams in India, Japan, the EU, and the USA.
As B2B is at the heart of our business model we work with several of the top pharmaceutical companies globally. Products based on our proprietary ideas are partnered for one or more territories at different stages of the development cycle.
We operate with the combination of product supply and our supporting services that provides our partners with the flexibility of choosing between product supply from the Extrovis sites or bringing manufacturing in-house.
We are dedicated to address the supply chain complexity of global pharmaceutical markets by reconciling high volume, efficient manufacturing with medium to small volume order demand.
GLOBAL STABILITY AND METHOD VALIDATION CAPABILITIES
PRIMARY & SECONDARY PACKAGING INCLUDING LATE-STAGE CUSTOMIZATION OF VARIOUS DOSAGE FORMS
SERIALIZATION
IMPORTATION, RE-TESTING AND RELEASE IN THE EU AND JAPAN
REGULATORY AND PHARMACOVIGILANCE PROCEDURES
SUPPLY CHAIN CO-ORDINATION AND CUSTOMER CARE
Extrovis Group operates state-of-the-art API manufacturing facilities with decades of experience and regulatory track record. The API manufacturing site is located in Italy with capabilities to handle high containment tonnage products including Penicillin, sterile Cephalosporins and Monobactams (Oral and Sterile).
Our manufacturing subsidiaries are equipped with infrastructure to produce a wide range of oral, parenteral and topical dosage forms including high containment products like antibiotics, oncology and female hormonal products.
A part of our portfolio is manufactured by contract manufacturing partners based on capacity sharing arrangements with the Extrovis Group to ensure long term supply continuity. The Extrovis Global Quality Management System oversees the entire manufacturing process, while our alliance management function gets involved with our partners every step of the way.
Our manufacturing sites are located in India, Italy, Japan, Hungary and in the United States of America.
Our sites are approved by several regulatory authorities including USFDA, EU, and PMDA Japan.
We maintain a balanced FDF portfolio that is driven by innovation. Our strategy focuses on formulation improvements that offer increased bioavailability, patient compliance and convenience, overall cost efficiency of therapy and/or medical waste management.
The R&D teams of the Extrovis Group apply a cross-functional approach utilizing expertise from multiple disciplines such as analytical, engineering, quality assurance, clinical, and regulatory affairs.
Our state-of-the-art development centres supported by a team of over 200 scientists has a proven track record of taking highly complex products and unique technologies from a portfolio concept to commercialisation.
In-house development of critical or low availability APIs to ensure long term cost competitiveness and supply chain continuity for our key projects.
The regulatory teams of the Extrovis Group are located globally across Europe, the United States, Japan and India and are capable of developing regulatory strategies and managing dossier submissions and compliance in multiple regulatory territories.
