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Our range of products
and services
Hovione has a track record for industrializing
processes for molecules that few other companies can match.
Our focus in developing and manufacturing difficult APIs has
given us a deep understanding of the challenges and opportunities
that exist in generic APIs.
Today, Hovione’s traditional expertise is complemented
by advanced technologies in API Particle Design, inhalation
formulation development as well as in the areas of parenteral
grade and high potency APIs. Additionally, an unblemished track
record at FDA assures our customers can take a totally compliant
environment for granted.
Hovione has over 90 DMFs filed worldwide and have been granted
10 CEPs. We assist our customers throughout the development
and registration stages by supplying impurities, technical documentation,
analytical methods, validation, stability and regulatory support.
During the last 6 years, Hovione has been involved in 3 FDA
pre-approval inspections for 8 products. As a result of the
service and quality we provide, every customer that has come
to Hovione has become a repeat customer.
Generic products
| • |
Tetracycline derived antibiotics: |
|
-
Doxycycline hyclate and monohydrate
- Minocycline
- Sancycline
|
| • |
Macrolides: |
|
-
Roxithromycin |
| • |
Mectins: |
|
-
Ivermectin |
| • |
Corticosteroids: |
|
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Betamethasones
- Beclomethasones
- Dexamethasones
- Fluticasone
- Clobetasol
- Halobetasol
- Mometasone |
|
| • |
Contrast Media: |
|
- Iopamidol
- Iohexol
|
| • |
Other Products: |
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Tamsulosin
- Sumatriptan succinate and base
|
| • |
New products
in development / launched |
|
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Iodixanol
- Fluticasone furoate
- Mometasone monohydrate
- Tiotropium bromide
- Ciclesonide
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API development and manufacturing services
Process development
R&D
| • |
Process development |
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Scale-up |
| • |
Process engineering |
| • |
Industrialization |
Multi-scale cGMP manufacturing
| • |
Validation batches |
| • |
Multi-scale manufacturing
from oral to parenteral use, including sterile bulk |
| • |
Particle Design |
| • |
cGMP spray drying at all
scales |
| • |
Controlled particle size
reduction using state-of-the-art technologies |
| • |
Micronization of APIs for oral, topical,
injectable and inhalation use |
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Supporting services
| • |
Continuous assessment of
processes |
| • |
Comprehensive review and
analysis of patent opportunities |
| • |
Analytical support |
| • |
Drug Product development |
| • |
Process validation |
| • |
Regulatory filing for ANDA
(either DMF or CMC sections) worldwide |
| • |
Synthesis and qualification
of reference standards and impurities |
| • |
Identification and isolation
of impurities |
| • |
Stability studies that conform
to ICH guidelines |
| • |
In-house engineering |
|
For further information on our products please contact:
Portugal
Pedro Couto Rosado
Account Manager
Phone: + 351 219 829 451
Fax: + 351 219 829 388 |
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USA
Carla Vozone
Business Development Director
Generics Business Unit
Phone: + 001 609 918 2466
Fax: + 001 609 918 2615 |
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About Hovione 
50 Years of Generic APIs
