Due to many inquiries about DMF issue, we put the detailed info here.
About Drug Master File (DMF)
About DMF filing in EU (called
EDMF), it is different to DMF filing in FDA.
FDA accept DMF file and give a
DMF number. Though it does not mean FDA approval or not approval. This DMF file
has 2 parts – An open part and the confidential part.
When a finished product
manufacturer apply license from FDA, the API supplier/DMF holder will provide an
Authority letter to FDA to allow the manufacturer access their entire DMF file.
EU Authority (EMEA) does not give
If the API is in Eu. Pharmacopoeia, EMEA can accept EDMF filing and issue a “Certificate of Suitability” for it.
If the API is not in Eu. P. EMEA would not accept DMF filing alone. – Paclitaxel is not in Eu. P yet.
So if you apply for Marketing Authorization in EU
countries, you need to reach agreement with the API supplier to provide you the
entire DMF file (which is technological confidential property of the API
factory). So you can including its content into your Marketing Authorization
application dossier to submit to EU authority (either your country’s Authority
or EU Authority).
Since July 2003, the EDMF file
has to be in CTD format. -n Common Technical Document (CTD)
Because the confidential nature
of the entire DMF file, the API supplier would not give it to any client but
only the large quantity long term clients. Also a confidential agreement has to
be signed to protect it.
Now you understand no any API
supplier can give you the entire DMF file for small quantity order. Normal
requirement is over kg PX order. In consider of medical devices manufacturers
may need less PX , we set up the lowest threshold level as 100gm PX. This is the
lowest level we can go.
The Paclitaxel API supply/DMF (CTD
format) contract draft is available.
21CEC Head Office
21CEC & 21CEP (UK & USA)
21CEC PX Pharm Ltd (UK)
Archer House, Britland Estate, Northbourne Road, Eastbourne, East Sussex BN22 8PW, UK
29 Harley Street, London W1G 9QR UK
1903 60TH PL, Suite M3039, Bradenton, Florida 34203, USA
Tel: (44) 0207 9276859 (UK) & Toll-Free (1) 888
2703429 (USA) & (44)
07732 971307 (CEO Direct line)
Fax: (44) 1323 763517 (UK) & (44) 1323 729777 (UK) & (1) 323 843 9307 (USA) & (1) 509 7524767 (USA)
E mail: firstname.lastname@example.org