COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP...

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COMPANY PROFILE

Transcript of COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP...

Page 1: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

COMPANY PROFILE

Page 2: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

YOUR ENTRY TO GMP

MANUFACTURINGCustomised production of

small batches

Page 3: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 4: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 5: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 6: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

Production layout

Production area with clean room zones conforming to GMP class C to A, suitable for highly potential active ingredients

Page 7: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

Clean room class B: facilities

workbenches

autoclave

Page 8: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

Clean room class B: ventilation concept

vertical unidirectional air flow in the entire room

air recirculation via intermediate floor

Page 9: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

Clean room class C: facilities

solution preparation

clean room washers

weighting area

Page 10: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 11: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

Business Fields

Production of investigational medicinal products

Contract manufacturing of authorized medicinal products

Compounding of patientspecific cytostatic and antibody treatment

Page 12: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 13: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 14: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

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

Page 15: COMPANY PROFILE - Pharmazeutische Lohnherstellung€¦ · COMPANY PROFILE. YOUR ENTRY TO GMP MANUFACTURING Customised production of small batches. History

CONTACT

Looking forward to a good co-operation

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