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Contract Manufacturer for FD: What's your Experience ???

 
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DrG
Moderator


Joined: 09 Jul 2007
Posts: 8
Location: Germany

PostPosted: 06-09-2008, 10:36    Post subject: Contract Manufacturer for FD: What's your Experience ??? Reply with quote

Hi there:

I noticed that there are always many questions and discussions in industry when it comes to contract manufacturer for freeze-drying, e.g. when a formulation has been developed "in-house" and an external contract manufactor is needed for scale-up and / or routine production. There is obviously an excessive number of companies available which provide contract development and manufacturing for freeze-drying. Some of them which come to my mind are as follows (a crude list! there are certainly many more):

Germany
Wasserburger Arzneimittelwerke, Rentschler Biotechnologie, Vetter Pharma, Thymoorgan, BAG Health Care, Haupt Pharma, IDT, etc.

Italy
Patheon, etc.

USA
DSM Pharmaceuticals, Ben Venue Laboratories, Catalent, Gilead Science, etc.

Switzerland
Inotech AG, etc.

France
Lipha, Pierre Fabre Group, etc.

What are others available in e.g. the UK, Belgium, Spain, outside of Europe, etc? Any ideas?

The selection of an appropiate contract manufacturer is certainly a question of drying time availability, equipment (analytical, freeze-dryer, etc.), expertise (handling, filling, etc), general reputation in the market, intended batch size (1k or 100k vials), and...costs.

I would like to post the following questions here: what are other contract manufacturer besides the ones listed above? What is your personal experience here? What type of equipment (freeze dryer, shelf area, etc.) and expertise do they have to offer and what batch sizes can be processed?

I am looking forward to your comments!

DrG
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kamalpharm2002



Joined: 24 Aug 2008
Posts: 2
Location: India

PostPosted: 08-25-2008, 05:43    Post subject: Contract manufacturer Reply with quote

Hi,
We do contract manafacturing for lyophlized product. We are actively perform Lyocycle development and Manufacturing facility for 25000 vials capacity.

Contact
Kamalanathan.S
Custom Pharmaceutical Services
Dr. Reddys Laboratories, Bachupally
India.
9959190207
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ramshanpharm



Joined: 24 Mar 2009
Posts: 9
Location: INDIA

PostPosted: 01-18-2010, 12:29    Post subject: Reply with quote

Hi,

We actively involved in contract manufacturing of lyophilized product, starting from lyophilization cycle development, optimization & scale-up of protein therapeuticals.

The scale may starts from 1000 vials to 12,000 vials with on-line filling, half-stoppering, sealing etc.

Thanks & Regards,

[b][color=green]Ramesh Kumar [/color][/b]
Formulation Research,

Intas Biopharmaceuticals limited,
Plot No. 423 / P / A/ GIDC
Sarkhej - Bavla Highway,
Moraiya, Taluka - Sanand, 382 210
Ahmedabad, Gujarat,India.

Telephone No. : +91 - 2717 - 660100/01
Fax : +91 - 2717 - 251189
Mob:+919724058366
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