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Company Profile
WÖRWAG R&D GmbH



Woerwag Research and Development GmbH, an independent subsidiary within the Wörwag
Pharma Group: we are dedicated to develop generic and OTC products as well as other added value
products (e. g. new application forms, diagnostic devices) according to european guidelines.

Our Mission: the right product right in time for launch upon patent expiry and for the right markets.

Our professional and enthusiastic team is realising the mission to develop a range of generics and
OTC-Products in up-to-date quality and meeting all regulatory, quality and IP requirements.

On the following pages, you can find our current developments and the readily compiled dossiers
with regulatory approval!

Please visit us on the Internet: www.woerwag-rd.com




Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle              www.woerwag-rd.com      1
Company Profile
WÖRWAG R&D GmbH

Readily Compiled Dossiers:

The following dossiers are readily compiled and have received german and some european Marketing
Authorisations. They are ready for submission in additional markets:

•Clopidogrel film coated tablets (75 mg); Original: Plavix, Iscover

•Enalapril-HCT tablets (20/12,5 mg); Original: Benalapril Plus

•HCT tablets (12,5 | 25 mg); Original: Esidrix

•Lagosa film coated tablets (Milk Thistle Dry Extract, corresponding to 150 mg Silymarin (UV))

•Lagosa capsules (Milk Thistle Dry Extract, corresponding to 86,5 mg Silymarin (HPLC))

•Losartan film coated tablets (12,5 | 25 | 50 | 100 mg); Original: Lorzaar

•Losartan-HCT film coated tablets (50/12,5 | 100/12,5 | 100/25 mg); Original: Lorzaar Plus

•Torasemid tablets (2,5 | 5 | 10 | 20 | 200 mg); Original: Torem, Unat

•Xipamid tablets (10 | 20 | 40 mg); Original: Aquaphor


Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle                      www.woerwag-rd.com   2
Company Profile
WÖRWAG R&D GmbH

  Current developments

  Currently we are developping the following products:

  •Candesartan tablets (2 | 4 | 8 | 16 | 32 mg), Dossier ready, DCP ongoing; Original: Atacand

  •Candesartan-HCT tablets (8/12,5 | 16/12,5 | 32/12,5 | 32/25 mg), Dossier ready until Q III-2011, DCP in Q IV-
  2011; Original: Atacand Plus

  •Donepezil film coated tablets (5 | 10 mg), Dossier ready, DCP ongoing, Original: Aricept

  •Galantamine xr capsules (8 | 16 | 24 mg), Dossier ready in Dec. 2010, DCP in Jan. 2011; Original: Reminyl

  •Levetiracetam film coated tablets (250 | 500 | 750 | 1000 mg), Dossier ready, DCP ongoing, Original: Keppra

  •Pioglitazon tablets (15 | 30 | 45 mg), Dossier ready, DCP ongoing, Original: Actos

  •Valsartan tablets (40 | 80 | 160 | 320 mg), Dossier ready, DCP ongoing, Original: Diovan




Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle                        www.woerwag-rd.com       3
Company Profile
WÖRWAG R&D GmbH


  Contact:

  Wörwag R & D GmbH
  Calwer Str. 7
  D-71034 Böblingen
  Germany

  Dr. Wolfgang Bäurle
  Head, Business Development

  Tel.: +49 7031-6204-794
  Fax: +49 7031-6204-72
  E-mail: Wolfgang.Baeurle@woerwagpharma.com
  Internet: www.woerwag-rd.com




Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle   www.woerwag-rd.com   4

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Woerwag R&D presentation Dec 2010

  • 1. Company Profile WÖRWAG R&D GmbH Woerwag Research and Development GmbH, an independent subsidiary within the Wörwag Pharma Group: we are dedicated to develop generic and OTC products as well as other added value products (e. g. new application forms, diagnostic devices) according to european guidelines. Our Mission: the right product right in time for launch upon patent expiry and for the right markets. Our professional and enthusiastic team is realising the mission to develop a range of generics and OTC-Products in up-to-date quality and meeting all regulatory, quality and IP requirements. On the following pages, you can find our current developments and the readily compiled dossiers with regulatory approval! Please visit us on the Internet: www.woerwag-rd.com Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle www.woerwag-rd.com 1
  • 2. Company Profile WÖRWAG R&D GmbH Readily Compiled Dossiers: The following dossiers are readily compiled and have received german and some european Marketing Authorisations. They are ready for submission in additional markets: •Clopidogrel film coated tablets (75 mg); Original: Plavix, Iscover •Enalapril-HCT tablets (20/12,5 mg); Original: Benalapril Plus •HCT tablets (12,5 | 25 mg); Original: Esidrix •Lagosa film coated tablets (Milk Thistle Dry Extract, corresponding to 150 mg Silymarin (UV)) •Lagosa capsules (Milk Thistle Dry Extract, corresponding to 86,5 mg Silymarin (HPLC)) •Losartan film coated tablets (12,5 | 25 | 50 | 100 mg); Original: Lorzaar •Losartan-HCT film coated tablets (50/12,5 | 100/12,5 | 100/25 mg); Original: Lorzaar Plus •Torasemid tablets (2,5 | 5 | 10 | 20 | 200 mg); Original: Torem, Unat •Xipamid tablets (10 | 20 | 40 mg); Original: Aquaphor Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle www.woerwag-rd.com 2
  • 3. Company Profile WÖRWAG R&D GmbH Current developments Currently we are developping the following products: •Candesartan tablets (2 | 4 | 8 | 16 | 32 mg), Dossier ready, DCP ongoing; Original: Atacand •Candesartan-HCT tablets (8/12,5 | 16/12,5 | 32/12,5 | 32/25 mg), Dossier ready until Q III-2011, DCP in Q IV- 2011; Original: Atacand Plus •Donepezil film coated tablets (5 | 10 mg), Dossier ready, DCP ongoing, Original: Aricept •Galantamine xr capsules (8 | 16 | 24 mg), Dossier ready in Dec. 2010, DCP in Jan. 2011; Original: Reminyl •Levetiracetam film coated tablets (250 | 500 | 750 | 1000 mg), Dossier ready, DCP ongoing, Original: Keppra •Pioglitazon tablets (15 | 30 | 45 mg), Dossier ready, DCP ongoing, Original: Actos •Valsartan tablets (40 | 80 | 160 | 320 mg), Dossier ready, DCP ongoing, Original: Diovan Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle www.woerwag-rd.com 3
  • 4. Company Profile WÖRWAG R&D GmbH Contact: Wörwag R & D GmbH Calwer Str. 7 D-71034 Böblingen Germany Dr. Wolfgang Bäurle Head, Business Development Tel.: +49 7031-6204-794 Fax: +49 7031-6204-72 E-mail: Wolfgang.Baeurle@woerwagpharma.com Internet: www.woerwag-rd.com Dec 2010 I Wörwag R&D I Business Development I Dr. Wolfgang Bäurle www.woerwag-rd.com 4