COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP...
Transcript of COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP...
COMPANY PROFILE
YOUR ENTRY TO GMP
MANUFACTURINGCustomised production of
small batches
History
• Viktoria Apotheke family owned since 1960, in 1995 takeover by Dr. Fritz Trennheuser, since 1997 focusing on manufacturing of sterile products
• Founding of Topmedicare GmbH in 2007, initially supplying retirement homes and care services with non-medical remedies and aids with focus on diabetes and parenteral nutrition
• Acquisition of Topmedicare GmbH in 2010 in one group with Viktoria Apotheke, developing the new business field of contract manufacturing of sterile and non-sterile products including IMPs
Exploiting synergies between manufacturer and pharmaceutical competence
production according GMP quality standards
Development of the corporate family
Since 2019:
Incorporation of PharmBioTec GmbH as subsidiary company of Topmedicare GmbH
Business fields:• Contract laboratory for analytical testing• Drug discovery and synthesis• Drug delivery
>> Topmedicare becomes a full service provider
Manufacturing authorisation
• Manufacturing license according to German Pharmaceutical Act (§13 AMG) for contract manufacturing of medicinal products including IMPs
• Quality management system according to EU GMP guide
Production layout
Production area with clean room zones conforming to GMP class C to A, suitable for highly potential active ingredients
Clean room class B: facilities
workbenches
autoclave
Clean room class B: ventilation concept
vertical unidirectional air flow in the entire room
air recirculation via intermediate floor
Clean room class C: facilities
solution preparation
clean room washers
weighting area
Further services
• Research & development in cooperation with PharmBioTec
• Quality control carried out by our in-house laboratory and external laboratories contracted for microbiological, stability and analytical testing
• Monitored storage areas with different temperature zones
Business Fields
Production of investigational medicinal products
Contract manufacturing of authorized medicinal products
Compounding of patientspecific cytostatic and antibody treatment
Contract Manufacturing and Supply Network
Formulation development
Production of API's (PharmBioTec)
Production of investigational medicinal products
Production of authorized medicinal products
Analytical testing
Market Access
Portfolio
Manufacturing processes compounding aseptic filling terminal sterilisation
Types of preparation solutions emulsions powders and more
Dosage forms and primary packaging injection vials infusion bags prefilled syringes
(such as intravitreal injections) cartridges nasal sprays eye drops and many more
Customer Benefits
Lean Structure:
• Direct customer support
• Short response time
• Reasonable costs
Young motivated team with strong backbone:
• Team of pharmacists and employees covering 30+ years of experience in the pharmaceutical industry
Integrated supply chain:
• API-manufacturing – development –contract manufacturing – delivery –market access
CONTACT
Looking forward to a good co-operation
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