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1 . What’s your main customers’ category?
Our main customers are Big Pharma, international small & medium size companies and companies without production facilities
2 . In which size (format) are the injectable ampoules you manufacture?
We do manufacture ampoules in 1ml, 2ml, 3ml, 3.5ml (filled in 5ml ampoules), 4ml, 5ml, 6ml, 10ml & 25ml.
3 . How do you control injectable ampoules?
Cenexi’s pinhole detection system for ampoules and vials uses a high voltage electrical field and impedance measurement to check each container at four inspection points. The container is examined for hairline fissures and pinholes, leaking ampoule neck tips, insufficient glass thickness at the tip and absence of fill. The latest in high frequency, high voltage technology ensures the reliable, accurate and non-destructive inspection required by today's growing industry standards
4 . Why do you perform labeling instead of pre-printing ampoules?
We do perform labeling in compliance with cGMP rules & recommendations (see text « ProjetMars 2005 1 DEMEB Affaires réglementaires PROJET Harmonisation de l'étiquetagedes ampoules de solution injectable de médicaments I. Contexte L'harmonisation et l'amélioration de la lisibilité de l'étiquetage concernent des médicaments » on the following link : http://agmed.sante.gouv.fr/htm/10/morphine/projet.pdf) instead of pre-printing ampoules, as it is easier to avoid mistakes whiles reading dosage forms.
Obviously, we can fill pre-printed ampoules on Client request.
5. Do you have any anti-counterfeit system for injectable ampoules?
Yes, we do have a system in cooperation with another company. Please contact us for any additional information
6 . What kind of tablets do you manufacture?
We do manufacture plain tablets, film coated tablets, sugar-coated tablets in a wide range of size and shapes
7 . What type of packaging do you perform?
We provide several types of blisters packaging for:
Solids (tablets and capsules) as blister in Alu/alu, Pvc/alu, Pvc Pvc/alu, plastic tubes and jars.
Ampoules as Pvc blister and carton Dividella.
Suppositories and ovulas are packed in Aluminum foils.
Syrups are filled in plastic or glass bottles, with or without accessories as spoons cups, in the boxes.
8 . Do you work for Japan?
We do work for Japanese big pharma.
9. Have you been audited and/or inspected by foreign countries? Who are they?
We’ve been audited and/or inspected by several foreign countries. Among them we have Saudi Arabia Kingdom, Brazil and Japan.
10.What is the lead-time for a quotation?
The standard lead-time for a quotation is 3 weeks provided that we have all the technical files concerning the product to quote.
11.What kind of additional services do you provide?
We provide Follow-up stabilities and Annual Product Review
12.Can you handle the registration files for your customers?
We can provide a complete variation dossier (CTD format) but it is our customers who must register their own product.
13.What do you mean by “full service”?
Study of the technical files
Proposal for an improvement of processes
Update of the manufacturing and the analytical files
Elaboration of variations dossier for regulatory authorities
Purchase and management of API, excipients, packaging items
Production, control, release
Stocks Reporting
Retain-samples storage room
+ Additional services: Ongoing stability, Annual Product Review.
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