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Productlist ac-Pharma [PDF]

Weg im Esterholz 6

82064 Straßlach

Telefon +49 89 666496-0

Telefax +49 89 619346

E-Mail info@ac-Pharma.de

Internet http://www.ac-pharma.de

Vertretungsberechtigter Vorstand: Achim Schneider

Vorsitzender des Aufsichtsrats: Hasso Kolberg

Registergericht: Amtsgericht München

Registernummer: HR 116537

Umsatzsteuer-Identifikationsnummer
gemäߧ 27 a Umsatzsteuergesetz: DE 128353659

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Address

Telephone    +49 (89) 666496-0

Facsimile    +49 (89) 61 93 46

E-Mail    info@ac-Pharma.de

Address

Weg im Esterholz 6

82064 Strasslach (near Munich)

GERMANY

Since 1984, ac-Pharma with Achim Schneider at the helm has been offering both approved German registrations and, increasingly, registration dossiers for the worldwide marketing (except the U.S.A.) of generics and added-value generics (i.e. new dosage forms and strengths of well-established molecules) as well as some innovative and patented projects.

We specialize in the development and handling of Mutual Recognition Procedures in compliance with the latest EU/ICH guidelines.

In doing so, we provide our customers with all-inclusive service from a single source:

• thus cutting their costs,
• saving them time, and freeing them to concentrate on the actual marketing of their products.

Our strengths are

Expertise

Experienced and highly qualified staff, who react quickly and commensurately to any and all challenges, stand behind the unvaryingly high quality of our registrations.

Innovation

For our customers we develop, in addition to traditional generics, new concentrations and dosage forms of established active ingredients (i.e., added-value generics), which helps them broaden their product lines and expand market coverage.

Efficiency

A high level of technical expertise and short decision-making channels guarantee fast, flexible solutions and lead quickly to the desired results.

Service

Our can-do service, tailored to your specific requirements, opens up perfect outsourcing possibilities for you. We handle entire registration processes – in your name if you wish – locate producers for the finished product, and help you obtain extensions of approved registrations. All of this from just one source.

• Interested? Just contact us.
  
• Your person to call at ac-Pharma

GENERIC PRODUCTS

• Acarbose tablets 50, 100 mg
• Acetylcysteine effervescent tablets 200 mg, 600 mg
• Acetylcysteine granules in sachets 200 mg
• Acyclovir tablets 800 mg
• Alendronate Sodium tablets 70 mg
• Ambroxol effervescent tablets 60 mg
• Amiodarone tablets 100, 200 mg
• Amlodipine maleate tablets 2.5, 5, 10 mg
• Amoxy Tri, Suspension, 125/200/250/400 mg/5ml
• Amoxicillin + Clavulanic Acid tablets 250/125 mg (*)
• Amoxicillin + Clavulanic Acid tablets 500/125 mg (*)
• Amoxicillin + Clavulanic Acid tablets 875/125 mg (*)
• Amoxicillin + Clavulanic Acid Injectables 0.5+0.1, 1+0.2, 2+0.2 g
• Amoxicillin + Clavulanic Acid PFOS 125/31.25/5ml, 250/62.5/5ml,
• Amoxicillin Capsules, 250 / 500 mg
• Atenolol tablets 25,50,100 mg
• Azathioprine film-coated tablets 25, 50 mg
• Azithromycin tablets 250, 500, 600 mg
• Azithomycin suspension 100 / 200 mg – 5ml
• Benazepril, tablets – 5, 10, 20, 40 mg
• Bisoprolol tablets 5, 10 mg
• Budesonide nasal 50 mcg/200 doses, 100 mcg/200 doses
• Calcium carbonate + Vitamin D3 effervescent tablets 1000mg + 880 I.U.
• Calcium carbonate + Vitamin D3 suspension 1200 mg + 800 I.U.
• Carbamazepine tabs ER, 100, 200, 400 mg
• Calcitonin nasal spray 2 ml and 3.5 ml
• Calcium carbonate effervescent tablets 500, 1000 mg
• Calcium Carbonate +Vitamin D3 chewable tablets
• 500 mg + 400 IU
• Carvedilol tablets 3.125, 6.25, 12.5, 25 mg
• Cefalexin Capsules 250, 500 mg
• Cefapime, Inj. 0.5, 1 + 2 g
• Cefazolin injection 0.25, 0.5,1 and 2 g
• Cefotaxime, Injection 0.25, 0.5, 1 g
• Cefpodoxime Oral Suspension 50, 100mg/5ml
• Cefpodoxime proxetile, Suspension, 50/5ml, 100/5ml
• Cefpodoxime proxetile, tablets 100, 200 mg
• Cefprozil pfos 125,250 mg/ 5 ml
• Ceftazidime 0.25,0.5,1,2,3, g
• Ceftibuten Caps 400 mg
• Ceftibuten Suspension 90 / 180 mg / 5ml
• Ceftriaxone, Inj. 0.25, 0.5, 1g
• Cefuroxim-axetil PFOS 125/25 mg / 5ml
• Cefuroxim-axetil tabs 125, 250, 500 mg
• Cefuroxime sodium Inj. 0.25, 0.75, 1.5 mg
• Cephalexin tablets, 250, 500, 750, 1000 mg
• Cetirizine tablets 10 mg
• Chlorhexidine cluconate solution for external use 4 %
• Ciprofloxacin film coated tablets 100, 250, 500, 750 mg
• Ciprofloxacin solution for infusion 2 mg/ml
• Cisapride oral solution 5 mg / 5 ml
• Citalopram film-coated tablets 10,20,30,40 mg
• Citalopram oral solution 40 mg/ml
• Clarithromycin film-coated tablets 250, 500 mg
• Clarithromycin pfos 125,250 mg/5ml
• Clarithromycin injectable
• Clarithromycin suspension 125/5 ml, 250/5 ml (available 12/07)
• Clopidogrel tablets 75 mg
• Dextromethorphan lozenges 10 mg (honey/lemon and aniseed flavour)
• Dextromethorphan oral solution 10 mg/5 ml
• Diclofenac gel
• Didanosine, chewable tablets 25, 50, 100, 150, 200 mg
• Didanosine ec-capsules 125, 200, 250, 400 mg
• Donepezil tablets 5, 10 mg
• Dorzolamide eye drop solution 2%, 5ml
• Dorzolamide + Timolol eye drop solution (2,0+0,5)%, 5ml
• Doxazosin tablets 1, 2, 4 mg
• Enalapril + HCT tablets 10 + 25 mg
• Felodipine tablets 2.5, 5, 10 mg
• Ferrous gluconate effervescent tablets 695 mg
• Fexofenadine film-coated tablets 30, 60, 120, 180 mg
• Finasteride tablets 5 mg
• Fluconazole injection, oral solution 100 mg/50 ml, 200 mg/100 ml
• Fluconazole tablets 50, 100, 150, 200 mg
• Fluoxetine capsules 10, 20, 40, 60 mg
• Fluoxetine solution 20 mg/5 ml
• Fluoxetine tablets 10, 20, 40 mg
• Fosinopril + HTZ, tablets 12.5/20 mg, 10/12.5 mg
• Furosemide tablets 40 mg
• Gabapentin capsules 100, 300, 400 mg
• Gabapentin tablets 100, 300, 400, 600, 800 mg
• Gatifloxacin tablets 200 / 400 mg
• Glipizide tabs ER 2.5 / 5 / 10 mg
• Gliclazide tablets 80 mg
• Glimepiride film-coated tablets 1, 2, 3, 4 mg
• Ibuprofen film-coated tablets 200, 400, 600 mg
• Ibuprofen 200, 400, 600 mg suspension in unit-dose sachets
• Ibuprofen suspension 2 % (in bottles)
• ISMN capsules (pellets) 40, 60 mg
• ISMN drops 4%
• ISMN s.r. tablets 100 mg
• L-Carnitine oral solution
• Lamotrigine tablets 2, 5, 25, 50, 100, 200 mg
• Lansoprazole capsules 15, 30 mg
• Levetiracetam tabs, 250, 500, 750, 1000 mg
• Lisinopril tablets 2.5, 10, 20, 30, 40 mg
• Lisinopril + HCTZ, tablets 10/12.5, 20/12.5, 12.5/20-25 mg
• Loratadine tablets 10 mg
• Losartan tablets 25,50,100 mg
• Losartan + HCTZ tablets 50-12.5, 100-25 mg
• Meloxicam tablets 7.5, 15 mg
• Metformin film coated tablets 500, 850 mg
• Metformin film coated tablets 1000 mg
• Methylprednisolone tablets 4, 8, 16, 32 mg
• Metoclopramide solution/drops, 5 mg/ml
• Metoprolol Succinate Tablets ER 25, 50, 100, 200 mg
• Mirtazapine tablets 15, 30, 45 mg
• Mirtazapine oral dispersible tablets 15, 30, 45 mg
• Morphine effervescent tablets 20 mg
• Olanzapine tablets 2.5, 5, 7.5, 10, 15 mg
• Omeprazole capsules (pellets) 10, 20, 40 mg
• Ondansetron film-coated tablets 4, 8, 24 mg
• Ondansetron i.v. 4, 8 mg
• Ondansetron OD tablets 4, 8 mg
• Oxcarbazepine film coated tablets 150 / 300 / 600 mg
• Pantoprazole tablets 20, 40 mg
• Paracetamol chewable tablets 500, 1000 mg
• Paracetamol effervescent tablets 500 mg
• Paracetamol tablets 500, 1000 mg
• Paroxetine tablets 10, 20, 30, 40 mg
• Paroxetine tablets SR, 12.5, 25, 37.5 mg
• Penicillin V tablets 125,250,500,1000 mg
• Penicillin V pfos 125,250 mg/5ml
• Pen V Suspension 250/5 ml
• Perindopril tablets 2,4,8 mg
• Piperacillin + Tazobact / Vial LYO 2+0.25, 3+0.375, 4+0.5 mg
• Pravastatin tablets 10, 20, 40 mg
• Quetiapine tablets 25, 100, 150, 200, 300 mg
• Quinapril tablets    5, 10, 20, 40 mg
• Quinapril + HCTZ tablets 10-12.5, 20-12.5, 20-25.0 mg
• Rabeprazol, tablets 20 mg
• Ramipril Capsules 1.25, 2.5, 5, 10 mg
• Ribavirin Capsules 200 mg
• Risperidone film-coated tablets 0.5, 1, 2, 3, 4, 6 mg
• Risperidone oral solution 1 mg/ml
• Roxithromycin film-coated tablets 150, 300 mg
• Selegiline tablets 5 mg
• Sertraline film-coated tablets 50, 100 mg
• Sildenafil tablets 25,50,100 mg
• Simvastatin film coated tablets 10, 20, 40, 80 mg
• Sumatriptan tablets 25, 50, 100 mg
• Sumatriptan succinate tablets 50, 100 mg
• Sumatriptan Injection 0,5 ml
• Tamsulosin capsules 0.4 mg
• Terbinafine tablets 125, 250 mg
• Tibolone tablets 2, 5 mg
• Ticlopidine tablets 250 mg
• Tolterodine Capsules ER 2, 4 mg
• Tolterodine tablets 1, 2 mg
• Topiramate tablets 25, 50, 100, 200 mg (available in 2007)
• Torsemide tablets 10, 20, 100 mg
• Trandolapril capsules 0.5, 1, 2, 4 mg
• Tramadol effervescent tablets 50, 100 mg, drops 100 mg / ml
• Venlafaxine Capsule ER 37.5 / 75 / 150 mg
• Zidovudin Capsules 250, 500 mg
• Zidovudin Oral solution 50 mg / 5 ml
• Zolpidem film coated tablets 5, 10 mg

(*)    This offer is not valid in some countries, kindly inquire about validity in your country.

ADDED-VALUE PROJECTS

(New dosage forms, new strengths)

• Amoxicillin chewable tablets 250, 1000 mg
• Calcium carbonate + Vit. D3 effervescent tablets
• 1000mg + 880 I.U.
• Cetirizine lozenges 10 mg
• Ibuprofen 200, 400, 600 mg suspension in unit-dose sachets
• Ibuprofen suspension 2 % (in bottles)
• ISMN solution / drops 4%
• ISMN s.r. tablets 100 mg
• Morphine effervescent tablets 20 mg
• Tramadol chewable tablets 50 mg
• Tramadol effervescent tablets 50, 100 mg
• Zolpidem effervescent tablets 10 mg (cannot be offered in France, Japan, Turkey)

INNOVATIVE AND PATENTED PROJECTS

• Amoxicillin liquitabs 250 mg
• Dry Powder System
  • Budesonide
    • 200 mcg, 200 or 250 puffs
    • 400 mcg, 100 or 200 puffs
  • Formoterol: in preparation, available in 2007
  • Fluticasone: scheduled end 2007/2008
  • Salmeterol: scheduled 2007/2008
  • Various combinations: after patent expiry

DERMATOLOGICAL PROJECTS*

• Betamethasone
  • Cream
  • Lotion
  • Ointment
• Clobetasol
  • Cream
  • Suspension
  • Fatty ointment
  • Ointment
• Dexamethasone
  • Suspension
  • Fatty ointment
  • Ointment
  • Tablets 4, 8 mg
• Methylprednisolone

  • Tablets 4, 8, 16 mg

• Prednisolone

  • Tablets 5, 10, 20, 50 mg

• Triamcinolone
  • Cream
  • Ointment

* This offer is not valid in Germany.

OTC PROJECTS

• Acetylcysteine effervescent tablets 200, 600 mg (OTC classification depending on indication)
• Acetylcysteine granules in sachets 200 mg
• Ambroxol effervescent tablets 60 mg
• Calcium carbonate + Vitamin D3 effervescent tablets 1000 mg + 880 I.U.
• Calcium carbonate + Vitamin D3 suspension 1200 mg + 800 I.U.
• Calcium carbonate effervescent tablets 500, 1000 mg
• Calcium carbonate chewable tablets 500mg
• Cetirizine tablets 10 mg
• Cetirizine lozenges 10 mg
• Dextometorphane lozenges 10 mg (honey/lemon and aniseed flavour)
• Dextometorphane oral solution 10 mg/5 ml
• Ferrous gluconate effervescent tablets 695 mg
• Ibuprofen film-coated tablets 400 mg (OTC classification depending on indication)
• Ibuprofen 200, 400, 600 mg suspension in unit-dose sachets (OTC classification depending on indication)
• Ibuprofen suspension 2 % (in bottles) (OTC classification depending on indication)
• Loratadine tablets 10 mg
• Paracetamol chewable tablets 500, 1000 mg
• Paracetamol tablets 500, 1000 mg
• Paracetamol effervescent tablets 500 mg

The products are classified as OTC in Germany.

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Productlist ac-Pharma (Juli 2007) [PDF]

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To open up …

broader markets for our customers, we include not only traditional generics in our portfolio, but also new dosage forms and concentrations. We develop generics and added-value generics: from the very first lab tests through to the product with EU-compliant dossier and approved registration.

Our customer …

list covers the entire world and includes both well-known producers of generics and researching multinationals. Whether in Germany, other EU countries, Eastern Europe, Asia, or Central and South America, we offer all customers our registration services – procedure, handling, etc.

We offer …

you approved registrations including the complete registration dossier with DMF in compliance with current requirements of the domestic and foreign authorities. If you are interested in an older product, we amend the dossier to conform with current EU/ICH guidelines.

We trade …

in registrations in Germany and other countries. Besides out-licensing, we also handle in-licensing. And, if you wish, we’ll work with you to find buyers for your products or registrations among our customers all over the world.

New ideas are our key for converting visions into reality. Our ultimate goals are the satisfaction and success of our customers. That’s why we develop both traditional and added-value generics and handle the entire registration procedure. Because added-value generics are so attractive and beneficial for patients (therapeutic security and improved compliance), we effectively offer our customers a clear competitive advantage. Experienced, highly motivated staff guarantee the unwaveringly high quality of our registrations. We are proud of the market-oriented flexibility of our product portfolio and the excellent, personal service we habitually provide.

We offer

• Developing traditional and added-value generics
• Conducting clinical studies on efficacy and bioequivalence
• Compiling registration dossiers
• Handling registrations for Germany, the EU and other countries
• Sale of registrations
• Supply of our pharmaceuticals at all stages of manufacturing –
  all manufacturers are E.U.-certified.