Hi infofreak16!!
I have found some generic fluticasone propionate (Flonase)
manufacturers and labs in Argentina, UK and USA. I know that there
must be more and I will continue researching; so please not consider
this question finished yet. I am posting this because I feel that you
need this info ASAP. Please let me know also if my research is well
oriented.
Researching at an Argentinian Vademecum (K@iros) I found some
laboratories that manufacture and sell generic fluticasone propionate
in many different presentations:
Laboratorio Pablo Cassara S.R.L.
Carhué 1096
(1408) Capital Federal
Tel.: 4641-5404/0505/5362 4642-7409 4642-9523
Brand: FLUTICORT
Laboratorios Raffo S.A.
Av. Cabildo 86
(1426) Capital
Tel.: 6347-7100
http://www.raffonet.com.ar/home.htm
Brand: FLUTI-K
Laboratorio Phoenix S.A.I.C.F.
Humahuaca 4065
(1192) Capital
Tel.: 4379-4200 4379-4244
http://www.phoenix.com.ar/esp/index.asp
Brand: RINISONA FLUTICASONA
Química Montpellier S.A. (Dist. DISPROFARMA)
Virrey Liniers 667
(1220) Capital
Tel.: 4127-0000 4127-0190
http://www.montpellier.com.ar/paginaqm/homeesp.html
Brand: PROAIR NASAL
Roemmers S.A.I.C.F.
Fray Justo Sarmiento 2350
(1636) Olivos - Bs.As.
Tel.: 4346-9700
http://www.roemmers.com.ar/home/home.asp
Brand: LIDIL CORT
From the United Kingdom the only generic manufacturer I found is IVAX
Pharmaceuticals:
IVAX Pharmaceuticals UK Limited
IVAX Quays,
Albert Basin,
Royal Docks
London,
E16 2QJ,
Main Contact Numbers: 0044 (0) 207 540 7000
http://www.ivax.co.uk
Brand: NASOFAN
Sources of this new:
"In 2005 IVAX is expecting approximately 13 new generic molecules to
launch. We have already been successful with the launch of Nasofan ?
Fluticasone spray and Lamotrigine."
From "IVAX UK: Generics":
http://www.ivax.co.uk/jsps/products/generics.jsp
"IVAX European revenues 15% growth came from the continued success of
many of our Central and Eastern European operations, contributions
from our Polish pharmaceutical company, Polfa Kutno, acquired in the
fourth quarter 2004, continued growth of QVAR sales and IVAX?
first-to-market launch of Nasofan, the generic equivalent of Flonase®,
in the United Kingdom, where it has established a 44% market share."
From "IVAX: Press Center Archived Story":
http://www.ivax.com/jsps/about/press_center_archive_story.jsp?StoryId=5949242
In the United States of America there are two authorized laboratories
to manufacture generic version of Flonase by the FDA, they are Roxane
and PAR Pharmaceuticals:
ROXANE Laboratories
Homepage: https://www.roxane.com/tpPortal/appmanager/touchpoint/rli?_nfpb=true&_pageLabel=rli_home_page
For contact info see:
https://www.roxane.com/tpPortal/appmanager/touchpoint/rli?_nfpb=true&_pageLabel=rli_common_page&page=contactus
See at Roxane's homepage the links to the following news:
Fluticasone Shipments Resume:
https://www.roxane.com/tpPortal/appmanager/touchpoint/rli?_nfpb=true&_pageLabel=rli_common_page&attach_image=&content_id=0900975a803b5b36&page=news
Fluticasone Propionate Nasal Spray:
https://www.roxane.com/tpPortal/appmanager/touchpoint/rli?_nfpb=true&_pageLabel=rli_common_page&attach_image=&content_id=0900975a803b079b&page=news
PAR Pharmaceutical:
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Phone: 1-800-828-9393
http://www.parpharm.com/index.jsp
http://www.parpharm.com/contact/
For confirmation see this press release:
"PAR PHARMACEUTICAL RESUMES SHIPMENT OF GENERIC FLONASE®":
http://www.parpharm.com/media/NR_20060307.jsp
That is all until now, I am continuing the research on this in Latin
America and Europe, I also found some manufacturers from India, but I
am not sure if you are interested on them, just let me know and I will
add the info to this answer for you.
Please use the clarification feature to request what you need from me
about this question, do not hesitate.
Search strategy:
Vedemecum fluticasona
Fluticasone manufacturer
Fluticasone manufacturer generic
I hope this start will be helpful to you, you will have more news from me soon.
Best regards,
livioflores-ga |
Clarification of Answer by
livioflores-ga
on
30 Mar 2006 09:05 PST
Hi again!!
I want to add the following UK company, it is not a manufacturer but...:
Savan Group:
Savan Group is an international trading organisation dealing mainly in
bulk pharmaceuticals for human and veterinary use, food grade and
industrial chemicals.
Savan Group,
PO Box 2061,
Steyning,
Sussex BN5 0AQ, England
Tel: +44 1903 815702, Fax: +44 1903 815759
http://www.savan.co.uk
At its pharmaceutical, food grade & veterinary products list appears
fluticonase listed, so they claim that they trade this product.
"Savan Group - pharmaceutical, veterinary and food grade products":
http://www.savan.co.uk/pharlist.html
"Savan Group - fluticasone propionate specifications":
http://www.savan.co.uk/fluticasone%20propionate%20spec.html
Hope this helps!!
Regards,
livioflores-ga
|
Request for Answer Clarification by
infofreak16-ga
on
30 Mar 2006 17:40 PST
Dear Livioflores:
Good work on the Argentinean generic formulators for Fluticasone
Propionate. I know that there are several companies in Europe who are
launching a Generic of Flonase. Could you kindly keep researching and
add that info to this question? Ivax, UK was helpful, but is Ivax
producing this generic themselves or are they getting it done through
another company?
I looked at Savan Group and they are a trading company dealing with
the Active ingredients. Manufacturers in India are also making the
Active Ingredient. I am more interested in Companies that are
manufacturing the generic for retail sale to doctors and patients.
If you need further info please let me know. I will be checking very
regularly for any updates that you post.
-Infofreak16-ga
|
Clarification of Answer by
livioflores-ga
on
30 Mar 2006 19:33 PST
Hi!!
I will continue the research, as you request.
Note that, according with a relatively recent press release from IVAX
and from the MRHA (Medicine and Healthcare Products Regulatory
Agency), NASOFAN is the only generic version approved in Europe. Since
the press release is from November, 2005 some things could have
changed, so give me some time to confirm or reject this hypothesis.
See:
"October 28, 2005
IVAX Receives Final Approval for Fluticasone Nasal Spray Across Europe:
MIAMI -- October 28, 2005--IVAX Corporation (AMEX:IVX, LSE:IVX.L,
WSE:IVX) receives final Mutual Recognition Procedure (MRP) approval
from the Medicine and Healthcare Products Regulatory Agency (MHRA) for
Fluticasone nasal spray in eleven countries across Europe.
It is expected that this approval will be followed by national
marketing authorization and launched in each country over the next few
months. Fluticasone is the generic equivalent of Flixonase® (known in
the U.S. as Flonase®) marketed by GlaxoSmithKline for the treatment of
rhinitis.
There are no other known generic alternatives presently marketed in Europe.
IVAX' Fluticasone nasal spray has already been approved in the U.K.
and was launched in May of this year.
IVAX Corporation also has an ANDA for Fluticasone nasal spray pending
with the U.S. FDA...."
http://www.ivax.com/jsps/about/press_center_archive_story.jsp?StoryId=1675478
I cannot confirm if they manufacture the drug by themself, but all
tends to such direction.
I also searched at the MHRA site and found some info regarding the
approval, the other European countries that granted marketing
authorisation to IVAX's NASOFAN:
Netherlands, Ireland, Spain, Denmark, Finland, Latvia, Lithuania,
Poland, Italy, Czech Republic and Slovakia.
http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2023039.pdf
I found a recent MHRA marketing authorisation to a GSK subsidiary,
Edinburgh Pharmaceutical Industries Limited (01/16/2006):
http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con2023082.pdf
Also I will continue with the Latin American generic manufacturers
research, I think that there are more, just need a few days to finish
that.
Let me know your thoughts about how I am managing this answer in order
to keep the focus on your priorities.
Regards,
livioflores-ga
|
Request for Answer Clarification by
infofreak16-ga
on
31 Mar 2006 05:12 PST
Dear Livioflores:
Research is headed in the right direction.
Basically keep your focus on formulators of generic Actives.
It would be great if you could find companies in Europe.
If you stumble upon generic companies in the far east (Taiwan,
Malaysia, Thailand, etc.) kindly paste that info also for my
information.
Regards,
Infofreak
|
Clarification of Answer by
livioflores-ga
on
31 Mar 2006 07:29 PST
Hi!!
Ok, roger that ;>). But let me finish with the Latin America research
and then I will continue with Europe. I do it in this way because I
think that there are more possibilities for successful results in
Latin America than Europe, since in Europe the approvals are just
begining and in L.A. generic flonase has been manufactured for years.
What I found is a Spanish pharmacological group (Faes Farma) that
manufactures and commercializes fluticasone, but licenzed by GSK:
FAES Farma:
Máximo Aguirre,14 - 48940 - Leioa (Vizcaya)
Apartado de Correos 555
48080 Bilbao (España)
E mail: imwakio@faes.es
Tel.: +34 94 481 83 00 - Fax: +34 94 481 83 23
http://www.faes.es
See the contact page for more detailed contact info:
http://www.faes.es/f_en.link?data=9bd1229c690bcc90
Brands: INALACOR, INALADUO, RINISONE
Regards,
livioflores-ga
|
Clarification of Answer by
livioflores-ga
on
01 Apr 2006 18:45 PST
Hi again!!
I got more generic manufacturers from Latin America:
COLOMBIA:
Biogen Laboratorios de Colombia
Carrera 36a No. 24-68,
Santa Fe De Bogota D. C ,
Colombia
Phone (571) 2695111
Fax (571) 2691908
Email: lbiogen@impsat.net.co
http://www.laboratoriosbiogen.com/
Brand: NOVEX
CHILE:
LABORATORIOS RECALCINE S.A.
Av.Pedro de Valdivia 295 - Providencia-Santiago.
TE: 3505200
FAX: 2397342
eMail: servicios@dif.recalcine.cl
Brands: (no nasal spray version)
FLUSONA Crema (fluticasone propionate cream)(through a subsidiary: MEDIDERM)
FLUSONA Aerosol (Fluticasone Oral Inhalation)(through a subsidiary: PEDIAPHARM)
Laboratorios Raffo S.A.
Avda. Simón Bolívar 2183
Ñuñoa - Santiago
Tel.: (56)-(2)-3411988
Chile
Email: laboratorios@labraffo.cl
http://www.labraffo.cl
Brand: RAFFONIN
ETEX FARMACEUTICA LTDA.
Av. Andrés Bello 2687 Piso 19
Las Condes-Santiago.
TE: (56)2-382-9000
FAX: 2039041
Brands:
BREXONASE Suspensión para Nebulización Nasal
BREXOTIDE LF Inhalador (Oral Inhalation - in combination with Salmeterol)
LABORATORIOS ANDROMACO S.A.
Av. Quilín 5273 - Peñalolén
Santiago - Chile
TEL: (56 2)5108500
FAX: (56 2)5108494
Email: info@andromaco.cl
WebSite: www.andromaco.cl
Brand:
ALBEOLER Aerosol para Inhalación (Fluticasone Oral Inhalation)
A detailed list of medicines containing Fluticasone and laboratories
from Chile is after this link (in Spanish, sorry):
"Fluticasona":
http://www.farmaciasahumada.cl/stores/fasa/html/mft/DROGAS/D1263.HTM
I also found some clues that leading me to include the following Chilean company:
Laboratorio Chemopharma S.A.
Av. Américo Vespucio N° 01260, Quilicura -
Santiago - Chile
Teléfono: (56-2) 4446600 -
Fax: (56-2) 4446651
Email: chemopharma@chemopharma.cl
http://www.chemopharma.cl/default.asp
Brand: just Fluticasona, I have not found any record about a brand
name for its generic version of fluticasone, neither a single mention
on the company's site and their list of products; but I found, at a
reputed pharmaceutical site, this company listed included their retail
prices in Chilean pesos (exchange rate is about 1 USD = 530 chilean
pesos).
To see the page go to:
http://www.revistakairos.com
Then select Chile and search for "fluticasona" without quotes. You
will get the following:
FLUTICASONA (CHEMOPHARMA)
Presentación: 125mcg /dosis Env. x 120 Dosis
Price: 7,000 (About 13.20 USD)
FLUTICASONA PROPIONATO/SALMETEROL 125/25 (CHEMOPHARMA)
Presentación: 125 /25mcg Aer. p/Inhalac. x 120 Dosis
Price: 13,000 (about 24.5 USD)
Researching for this company (ChemoPharma) I found an Austrian company
with the same name (coincidence?) that includes in their
PHARMACEUTICAL RAW MATERIAL products Fluticasone Propionate, see:
http://www.chemopharma.com/pharmaceutical_raw_material.htm
I know that you are not after raw material manufacturers but this
could be a great clue for your purposes, so I include the contact info
for you:
CHEMOPHARMA
Chemikalien- und Pharmazeutika Handelsges.m.b.H.
A-1150 Wien/Austria; Reindorfgasse 13
Tel. (43-1) 89117-0, Fax: (43-1) 8940215
e-mail: office@chemopharma.com
VAT-No.: ATU14217701
http://www.chemopharma.com/index.html
http://www.chemopharma.com/Representing%20Offices.html
From now i will focus my efforts on European laboratories, I hope I
can find any, fingers are crossed ;>).
Hope this helps you.
Regards,
livioflores-ga
|
Request for Answer Clarification by
infofreak16-ga
on
06 Apr 2006 07:04 PDT
Hey Livioflores:
Any luck in Europe or anywhere else?
Regards.
Infofreak
|
Clarification of Answer by
livioflores-ga
on
06 Apr 2006 23:27 PDT
Hi!!
Not yet but I am working on it, I sent some mails and waiting
confirmations I hope to get something for you soon.
In the meantime you can try with some Asian manufacturers that I found:
The following two manufacture generic fluticasone propionate for retail sale.
Cipla Ltd.
Mumbai Central
Mumbai 400 008
India
Telephone: 2308 2891
2309 5521
Fax: 91 22 2307 0013
91 22 2307 0393
Emails list: http://www.cipla.com/contactus/e-mail.htm
Homepage: http://www.cipla.com
Brands:
Flutinase Nasal Spray
http://www.cipla.com/admin.php?mode=prod&action=disp&id=444
Seroflo HFA Inhaler
http://www.cipla.com/admin.php?mode=prod&action=disp&id=121
Seroflo Inhaler/Rotacaps
http://www.cipla.com/admin.php?mode=prod&action=disp&id=120
They also can provide Fluticasone Propionate as Active Pharmaceutical Ingredient:
http://www.cipla.com/ourproducts/bulkdrugs/api.htm#f
The other company is Sun Pharma:
Sun Pharmaceuticals Industries Ltd.
17 B Mahal Industrial Estate,
Mahakali Caves Rd Andheri (E),
Mumbai 400 093.
Tel.: (91-22) 5645 5645
Fax: (91-22) 5645 5685.
Email: corpcomm@sunpharma.com
Homepage: http://www.sunpharma.com/index.html
Brands:
Combitide and Floease
See the following page at Anti-asthmatics section for info about presentations:
http://www.sunpharma.com/formulations_active.htm
I also found three companies that claim they are manufacturing the
active component but I received some info that they make formulations
also, just try contacting them:
TIANJIN HI-TESION PHARMA&CHEM CO., LTD
ELINA SUN: BUSINESS MANAGER
TEL: 86-22-23725099
FAX: 86-22-23726399
EMAIL: elina3153@yahoo.com; hi_tesion@yahoo.com.cn
MSN: sunnysunnyunderthesun@hotmail.com
Nivon Specialties
Plot # G-16,
RH-5,Sector-06,
Vashi, New Mumbai,
INDIA. Pin: 400 703.
Telephone : 91-9323789882
Fax : 0091-22-27824698
Email: info@nivonindia.com
nivonindia@hotmail.com
Homepage: http://www.nivonindia.com
Yier Hi-Tech Bio-Pharm Co.,Ltd
12F Gaoke Building, No. 52 Gaoxin Road,
Development Zone for Hi-Tech Industries
Xi'an 710075 China
TEL?029-88316539 88315135
FAX?029-88322669 88322467
E-mail?trade@yier.cn
Homepage: http://www.yier.com.cn/english/default.asp
Hope this helps, and also hope to find something useful to you in Europe.
Regards,
livioflores-ga
|
Clarification of Answer by
livioflores-ga
on
10 Apr 2006 00:18 PDT
Hi again infofreak!!
I continued the research for an European generic manufacturer of
fluticasone formulations, but without success. The only laboratory
authorized to do that is IVAX as I told you. There are some Active
Pharmaceutical Ingredients (APIs) manufacturers, for example Hovione.
But this companies works mainly for regulated markets (US, EU and
Japan), selling the API to companies that produce the medicine
licenced by GSK. There are some clues that this status can change in
the short run, the GSK exclusive license is close to its expiration
date (but in some places like Spain it can be renewed) and the recent
approval that IVAX gets for itself.
Nowadays the main source for generics (in this case we are talking
about the generic products offered by the online pharmacies) are the
Indian laboratories, and fluticasone is not the exception. I have
listed for you a couple of them (the most renowned and popular) Indian
labs and now I can give you one more lab that works worldwide:
- Lotus International:
Presently exporting to some of the African, Latin American, South East
Asian and Middle East Countries. Company is managed by Dr. Omprakash
Jagnani.
Contact:
Dr. Omprakash Jagnani.
OR
Mr. Purshottam Malsisaria.
LOTUS INTERNATIONAL
Unit No-206, Unique Towers,
Off. S. V. Road,
Goregaon (West),
Mumbai- 400 062.
INDIA.
Tel:- +91-22-2877 7767, 2877 7704
Fax :- +91-22-2877 3944
E-mail :- lotus@lotusinternational.com, lotusint@vsnl.com
Under its list of generics products you can find listed:
"GENERIC NAME / FORMULATION / STRENGTHS / INTERNATIONAL BRAND NAME
Fluticasone Capsules / 50-100-200mcg / Advair - Flonase "
LOTUS INTERNATIONAL -Generics:
http://www.lotusinternational.com/generic.htm
I found two more labs in Spain that produce formulations similar to
GSK's fluticasone formulations, but remember that they do that under
GSK license:
- Almirall Prodesfarma, S.A.
General Mitre, 151
08022 Barcelona - España
Tel. + 34 93 291 30 00
Fax + 34 93 291 31 80
http://www.almirall.es/almirall/cda/index_eng.jsp
Brands:
PLUSVENT, FLUINOL and FLUSONAL
- Laboratorios Alter S.A.
Manufacturer of pharmaceuticals and cosmetics.
Mateo Inurria 30
28036 Madrid
Spain
Phone ++34 91 3592000
Fax ++34 91 3591827
http://www.alter.es
Brands:
ANASMA and TRIALONA
Again just in case you have here details about Hovione, an APIs manufacturer:
- HOVIONE S.A.
Sete Casas, Loures 2674-506, Portugal
Phone: +351-(21)-982 9125
Fax: +351-(21)-982 9118
http://www.hovione.com
See these pages:
http://www.hovione.com/Fluticasone/
And specially this report could be of your interest (for further
details register for free at the site):
Hovione - Fluticasone - Commercial Overview:
http://www.hovione.com/fluticasone/commercial.htm
Regarding the European pharma market you can get a better understand
of its patent's regulations after reading the following article (it
includes references on the GSK/fluticasone status):
"Lovells - European Union - 2004 - Annus Horribilis for Innovative
Pharma? (21/03/2005)" from Mondaq:
http://www.mondaq.com/i_article.asp_Q_articleid_E_31499
To read it you must register at this place for free, you can also see
a cached version here:
http://72.14.203.104/search?q=cache:Y0NFYTpBU4QJ:www.mondaq.com/i_article.asp_Q_articleid_E_31499+fluticasone+italy+generic&hl=en&ct=clnk&cd=28
Regarding the North American market, it is probably that in the short
or mediun run a new actor enters in the generic fluticasone
manufacturers club, Apotex (a Canadian company), see the following
article:
"GlaxoSmithKline loses fluticasone case Apotex' generic version of
Flonase (fluticasone propionate nasal spray)":
http://www.dancewithshadows.com/hara/fluticasone.asp
- Apotex Inc.
150 Signet Drive
Weston, Ontario M9L 1T9
Telephone: (416) 749-9300
Facsimile: (416) 401-3835
Order Desk : 1-877-4-APOTEX (Toll Free in North America)
General Inquiries: 1-800-268-4623
http://www.apotex.ca/En/Default.htm?/En/contactus/Contents.htm
- Apotex Corporation USA:
2400 North Commerce Parkway,
Suite 400, Weston, Florida 33326
Phone: 1-800-706-5575
Contact Apotex Drug Information for specific product related
questions: DISpedia@apotex.com
http://www.apotexcorp.com/talk_frameset.html
I hope that this satisfies your needs. I will keep an eye open to see
if something new appears, but from now I will not do a further
research; due the last results and news I think that I will not be
able find an european manufacturer as you request. Feel free to
continue using the clarification feature if you like to request
something else related to this question.
Best regards,
livioflores-ga
|
Request for Answer Clarification by
infofreak16-ga
on
10 Apr 2006 23:24 PDT
Thanks livioflores.
I have added a rating to the question. I will request you to research
more, at your convenience, about the Europeans.
Regards,
Infofreak
|
Clarification of Answer by
livioflores-ga
on
11 Apr 2006 01:02 PDT
Dear infofreak!!
Thank you so much for the good rating and the very generous tip!!
It is always welcome knowing that our work is useful to our costumers.
As I told you I will keep an eye open on the europeans fluticasone
manufacturers.
I hope you will continue trusting in us by requesting more answers
when you need them.
Warm regards,
livioflores-ga
|
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