I am interested in receiving list information of all the
pharmaceutical and nutraceutical (those that manufacture nutritionals
such as vitamins)laboratories in the United States registered with the
FDA (Food and Drug Administration). Beyond the obvious
inclusion of the larger companies, we are interested in ensuring that
the list contains all laboratories regarding of size. Minimum
information requirements would be name, address, telephone and
website.

---

Request for Question Clarification by pafalafa-ga on 06 Dec 2003 15:25 PST

I can direct you to a list of several thousand laboratories registered
with the FDA for manufacturing drugs.  I'm sure many of them
manufacture nutraceuticals as well, although they are not regulated in
the same manner as drug manufacturers -- companies that *only*
manufacture nutraceuticals may not be included on the list.

Typical entries include name, address and phone number (no web site
information), and look like this:

AGA LINDE HEALTHCARE PUERTO RICO INC  11 HOSTOS AVE, PONCE, PR, 00716,
UNITED STATES  787-6208130

--------------------------------------------------------------------------------
 
AIR WAY OXYGEN INC  1908 MORTH MITCHELL, CADILLAC, MI, 49601, UNITED S
 616-2473900

--------------------------------------------------------------------------------
 
AIRGAS GREAT LAKES INC  5527 ENTERPRISE BLVD, TOLEDO, OH, 43612,
UNITED ST  989-4962210

--------------------------------------------------------------------------------
 
AIRGAS MID AMERICA INC  1 OREGON ST, CHARLESTON, WV, 25312, UNITED
STATES  270-8429489

--------------------------------------------------------------------------------
 
AIRGAS NOR PAC INC  950 POWELL AVE SOUTHWEST, RENTON, WA, 98055, UNITE
 206-2240433

-------------------------------------------------------------------------------

As I said, there are several thousand companies listed although I
cannot guarantee that EVERY such company that you may be interested in
is included in the list.

Let me know if you would like me to post information about accessing
the list as an answer to your question.

---

Clarification of Question by fertico-ga on 08 Dec 2003 09:40 PST

Although I am aware that nutraceutical companies are not regulated as
stringently as pharmaceutical compananies, our company has a
commercial interest in selling to both (since the laboratories share
products used in both environments). Nevertheless, our main interest
is to have a list of all registered pharmaceutical/nutraceutical labs
in the United States regardless of size.

---

Request for Question Clarification by pafalafa-ga on 08 Dec 2003 11:53 PST

Hello again, fertico-ga,

Just to be clear, you wrote: "...our main interest is to have a list
of all registered pharmaceutical/nutraceutical labs in the United
States regardless of size."

If this is the only answer that would be acceptable to you, I'm afraid
I cannot help you.  I simply have no way of knowing whether my list
captures ALL the labs out there, or the proportion that might not be
included.

However, I can point you to a list of several thousand labs registered
with the FDA, who produce both pharmaceuticals and nutraceuticals.  I
don't want to post this information as an answer to your question
unless it would fully meet your needs.

Please let me know if you would like this information posted as an
answer to your question.  If you would like me to spot-check a few
companies, to see if they are included, just post their names here,
and I'll tell you if they're on the list or not.

Thanks...and best of luck in your venture.

---

Clarification of Question by fertico-ga on 08 Dec 2003 12:30 PST

If your list contains several thousand labs, and if it contains
pharmaceutical and nutraceutical labs, I am sure that I will able to
obtain the information I am seeking from this list. Please post this
information and I will consider the question answered. Thank you

---

Request for Question Clarification by pafalafa-ga on 08 Dec 2003 13:18 PST

Hello fertico-ga,

Thanks so much for sticking with the process as we clarified the type
of information that would best meet your needs.

The U.S. Food and Drug Administration requires firms that manufacture
"drugs and biological products" to register with the FDA.  A guidance
document explaining the registration requirements in detail can be
found here:

----------

http://www.fda.gov/cder/guidance/4316dft.htm

Guidance for Industry
Forms for Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution

"Section 510 of the [Federal Food, Drug, and Cosmetic] Act and 21 CFR
part 207, inter alia, require establishments (e.g. manufacturers,
repackers, and relabelers) upon first engaging in the manufacture,
preparation, propagation, compounding, or processing of human drugs,
veterinary drugs, and biological products, with certain exceptions, to
register their establishments and submit listing information for all
drugs and biological products in commercial distribution. Registrants
are also required to submit, on or before December 31 of each year,
updates in registration information for their establishments."

----------

A list of FAQs regarding the registration process can be found here:

http://www.fda.gov/cder/dfars/drlsfaq.htm

Frequently Asked Questions on Drug Firm Annual Registration Status

----------

The list of firms, itself, is accessible through a search site
maintained by FDA, which can be found here:

http://www.fda.gov/cder/dfars/docs/querydrls.htm

Drug Firm Annual Registration Status Query
Search by Firm Name:

----------

Enter "inc" into the search box (without the quote marks) and the
system will return a list of several thousand firms.

Once you have the list on screen, you can search it for firms of
interest, using your browser's Find function (Ctrl-F in a Windows
system).  For instance, a Ctrl-F search for "nutra" identifies a
number of firms with nutraceutical and related terms in their company
name, such as:

NUTRACEUTICAL LABS INC  3617 WEST CAMBRIDGE AVE, PHOENIX, AZ, 85009, 602-9958715 


And of course, you can use your browser's "Save As" function to save
the entire list as a text file or html file on your local drive.

I trust this is the information you need, but if anything here is not
clear, or if you would like any additional information, just let me
know by posting a Request for Clarirfication, and I'll be happy to
assist you further.

pafalafa-ga


search strategy:  used bookmarked FDA search sites

Hello fertico-ga,

Thanks so much for sticking with the process as we clarified the type
of information that would best meet your needs.

The U.S. Food and Drug Administration requires firms that manufacture
"drugs and biological products" to register with the FDA.  A guidance
document explaining the registration requirements in detail can be
found here:

----------

http://www.fda.gov/cder/guidance/4316dft.htm

Guidance for Industry
Forms for Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution

"Section 510 of the [Federal Food, Drug, and Cosmetic] Act and 21 CFR
part 207, inter alia, require establishments (e.g. manufacturers,
repackers, and relabelers) upon first engaging in the manufacture,
preparation, propagation, compounding, or processing of human drugs,
veterinary drugs, and biological products, with certain exceptions, to
register their establishments and submit listing information for all
drugs and biological products in commercial distribution. Registrants
are also required to submit, on or before December 31 of each year,
updates in registration information for their establishments."

----------

A list of FAQs regarding the registration process can be found here:

http://www.fda.gov/cder/dfars/drlsfaq.htm

Frequently Asked Questions on Drug Firm Annual Registration Status

----------

The list of firms, itself, is accessible through a search site
maintained by FDA, which can be found here:

http://www.fda.gov/cder/dfars/docs/querydrls.htm

Drug Firm Annual Registration Status Query
Search by Firm Name:

----------

Enter "inc" into the search box (without the quote marks) and the
system will return a list of several thousand firms.

Once you have the list on screen, you can search it for firms of
interest, using your browser's Find function (Ctrl-F in a Windows
system).  For instance, a Ctrl-F search for "nutra" identifies a
number of firms with nutraceutical and related terms in their company
name, such as:

NUTRACEUTICAL LABS INC  3617 WEST CAMBRIDGE AVE, PHOENIX, AZ, 85009, 602-9958715 


And of course, you can use your browser's "Save As" function to save
the entire list as a text file or html file on your local drive.

I trust this is the information you need, but if anything here is not
clear, or if you would like any additional information, just let me
know by posting a Request for Clarirfication, and I'll be happy to
assist you further.

pafalafa-ga


search strategy:  used bookmarked FDA search sites


P.S.  I inadvertently posted this as a clarification, as well...sorry
for any confusion.