1. Have you had an inspection by FDA?
2. Do you have
experience with filing a DMF File?
3. How does Hamari Chemicals ensure
cGMP?
4. Do you offer kg scale production?
5. Do you synthesize clinical
compounds?
6. Do you offer process optimization services?
7. From the early stages
of non-clinical tests to IND applications, can Hamari undertake drug
substance CMC parts consistently?
8. What is the total capacity of
the reactors?
9. Are beta-Lactams (penicilin/cephalosporine), argochemical,
steroid, cytotoxic, pesticide or any other potent substance produced
at your plant?
10. Do you have a reaction specialty?
11. Do you use any special equipment?
12. Are you ISO14001 certificated?
13. What kind of solvents can be
used in your production facility?
14. What kind of reactions doesn’t
Hamari Chemicals perform?
1. Have you had an inspection by FDA?
Our plant was inspected by FDA on March 2006 and we received approval
in July 2006.
2. Do you have experience
with filing a DMF File?
Yes, we had several US DMF files and EDMF and CEP, which were forwarded
to the FDA, the DHSS and European Authorities.
3. How does Hamari Chemicals ensure cGMP?
The cGMP facts sheet reviews the typical questions & answers
occurring during an audit. If you would like to receive a copy, please
contact us by fax or e-mail.
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4. Do you offer kg scale production?
Yes, we offer production on kg scale. We can manufacture from kg to
several ten tons of a compound when ordered by a customer.
5. Do you synthesize clinical compounds?
Yes, as a custom manufacturer we supply approximately 25 compounds
in a year. 30% of those are clinical compounds.
6. Do you offer process optimization services?
With regards to the synthesis process used in our laboratories, we
take a practical approach to manufacturing and conduct examinations
to increase efficiency. Click
here to view our technical expertise page.
We deliver the highest quality products, on time and on budget, all
in accordance with Japanese and international pharmaceutical laws.
Reactions are conducted safely and we pride ourselves on our environmental
policy.
For any chemicals we can not manufacture, we are happy to propose
other methods to best achieve your goal.
We honor and respect the confidentiality of our clients and their
products and observe Non-Disclosure agreements on a regular basis.
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7. From the early stages of non-clinical tests to IND applications,
can Hamari undertake drug substance CMC parts consistently?
From the early stages of non-clinical tests to IND applications, Hamari
will work with you through to and help with IND requests and applications.
On top of our manufacturing process, data from drug substances' physical
properties is recorded, analyzed and validated.
Both our Kunijima, Osaka and Yonezawa plants are cGMP certified. The
Yonezawa factory is FDA approved.
During meetings prior to IND, we will advise and cooperate working
together with you, and will also assist with the CMC parts of IND applications.
8. What is the total capacity of the reactors?
Please see the specialized equipment section.
9. Are beta-Lactams (penicilin/cephalosporine), argochemical, steroid,
cytotoxic, pesticide or any other potent substance produced at your
plant?
No, they are not.
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10. Do you have a reaction specialty?
Please see the Core Reactions section by clicking here.
11. Do you use any special equipment?
Please see the Specialized Equipment page by clicking here.
12. Are you ISO14001 certificated?
Yes, we are certified ISO14001 since February 16, 2001.
13. What kind of solvents can be used in your production facility?
We can use all solvents generally used in organic chemical synthesis.
(Except for Diethyl Ether, Chloroform, Benzene, and Dioxane.)
14. What kind of reactions
doesn’t Hamari
Chemicals perform?
We don’t perform:
• High temperature reactions (200-300˚C)
• Precise distillations for purification
• Phosgene chemistry
• Fluorination
• Reductions using Diborane
• Oxidations using Ozone
• Photo-reactive Chemistry
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