Expertise and teams dedicated to transfer and development

Cenexi brings together a pole of expertise supporting formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support.

A service upstream and downstream of the manufacturing process

In addition to industrial-scale drug manufacturing and packaging, Cenexi offers its customers a complete range of services:

Upstream, during the drug development stages ;
Downstream, by providing regulatory and logistical services. Regardless of whether the innovative products to be manufactured on Cenexi sites are experimental or already on the market.

These services are provided by dedicated teams of 110 experts* specializing in formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support.

The Cenexi teams thus provide solid expertise and cutting-edge know-how to support projects from preformulation to commercial production, for all pharmaceutical forms.

* Figure as of January 1, 2023.

FORMULATION

Cenexi’s experts handle all preformulation and formulation needs. They will design all the necessary steps to validate the manufacturing process, API quality and choice of excipients.

They conducts formulation work for:

Sterile vials, liquid or freeze-dried, including cytotoxics
Prefilled syringes including cytotoxics
Aseptic and sterilized injectable ampoules
Sterile ophthalmic gels
Tablets and capsules, including hormones, uncoated, film-coated, sugar-coated, sustained-release, double core, gastro-resistant
Syrups, creams and lotions

Cenexi also offers a wide range of primary and secondary packaging adapted to the specific needs of products.

Analytical development

Analytical experts teams offer extensive services that include the following:

Study of active ingredients
Development, optimization, transfer, check and validation of analytical methods for drug products, raw materials and cleaning methods
Development and validation of dissolution profiles
Development and update of analytical methods for degradation products (ICH Q3B)

Process development and optimization

With its dedicated facilities, Cenexi can manufacture batches for all development stages, from preformulation to clinical trials, and cover a wide range of formulations highly active formulations to more traditional pharmaceutical forms.

Primary packaging supported includes :

Sterile solutions
Sterile suspensions
Sterile emulsions
Solid forms (tablets and capsules)
Sterile lyophilized forms
Syrups, creams and lotions

Cenexi Services can also perform the filling of a broad range of primary packaging, including :

Bottles, in glass and PE
Syringes
Ampoules
Tubes
Blister packs

Clinical batches

Cenexi can manufacture drug products for clinical trials:

Solid forms including hormones (1kg batches, minimum)
Sterile liquid forms including cytotoxic (1L batches, minimum)
Lyophilized forms

Technical transfer and validation

Cenexi sets up a multidisciplinary team dedicated to each transfer project and headed by a dedicated project manager:

Upon receipt of the client’s documents, we establish a GAP analysis to discuss the proposed transfer strategy and planning with him
Our process and analytical experts will critically review the strategy and identify any possible process and methodology enhancements
The validation and stability studies are executed as expeditiously as possible
Variation files and other administrative procedures are written or reviewed according to expectations

Stability testing

Cenexi conducts pre-stability, regulatory or commercial stability studies, according to the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) conditions:

– 20°C
5 °C
25 °C/60 % RH
30 °C/65 % RH
30 °C/75 % RH
40 °C/75 % RH
Photostability

Regulatory support

Cenexi is renowned for its strong regulatory expertise and can provide expert counsel regarding any aspect of your regulatory strategy.

Our regulatory experts will create your market authorization files (CTD module 3) and variation files. We have a broad knowledge of the requirements for marketing authorization applications in 124 different countries, as we are registered with the public health authorities of these countries for which we manufacture drugs. This of course facilitates the registration of our sites for new manufacturing transfers.

Finally, all of our Cenexi sites have been successfully inspected by the major regulatory bodies:

ANSM (France)
AFMPS (Belgium)
ANVISA (Brazil)
FDA (United States)
KFDA (South Korea)
PMDA (Japan)

ANSM (France)
AFMPS (Belgium)
ANVISA (Brazil)

FDA (United States)
KFDA (South Korea)
PMDA (Japan)

Discover below the countries where Cenexi is registered:

South Africa

Algeria

Botswana

Côte d’Ivoire

Egypt

Ethiopia

Ghana

Gibraltar

Equatorial Guinea

Kenya

Libya

Madagascar

Malawi

Morocco

Mauritania

Namibia

Nigeria

Central African Republic

Sudan

Tunisia

Zimbabwe

Argentina

Aruba

Bahamas

Barbados

Bolivia

Brazil

Canada

Chile

Colombia

Costa Rica

Cuba

Ecuador

United States

Guatemala

Guyana

Haiti

Honduras

Jamaica

Mexico

Nicaragua

Panama

Paraguay

Peru

Dominican Republic

St. Vincent & Grenadines

El Salvador

Trinidad & Tobago

Uruguay

Saudi Arabia

Armenia

Azerbaijan

Bahrain

Bangladesh

Cambodia

China

United Arab Emirates

Georgia

Indonesia

Iran

Israel

Japan

Jordan

Kazakhstan

Kuwait

Laos

Lebanon

Malaysia

Nepal

Oman

Uzbekistan

Pakistan

Philippines

Qatar

Hong Kong SAR China

Russia

Singapore

Sri Lanka

Syria

Taiwan

Palestinian Territories

Thailand

Turkmenistan

Ukraine

Vietnam

Yemen

Albania

Germany

Austria

Belgium

Bosnia & Herzegovina

Bulgaria

Cyprus

Croatia

Denmark

Spain

Estonia

Finland

France

Greece

Hungary

Ireland

Iceland

Italy

Latvia

Lithuania

Luxembourg

Malta

Monaco

Norway

Netherlands

Poland

Portugal

Romania

United Kingdom

Slovakia

Slovenia

Sweden

Switzerland

Czechia

Turkey

Australia

New Zealand

Product life cycle management

Cenexi supports continuous product improvement in the following areas:

Analytics
Formulation
Process
Packaging
Regulatory
Brand extension development