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Customer support
With an experience of 49 years in the global market
of off-patents APIs, Hovione has a deep understanding of the patent, time-to-market,
bioequivalence and regulatory challenges linked to this business. Hovione
supplies its Customers with technical support that will cover all chemistry,
analytical and registration issues. On occasion, Hovione will also supply
formulation information.
We assist our Customers throughout the development and registration stages
by supplying impurities, technical documentation, analytical methods, validation,
stability and regulatory support. The supply of impurity samples, improved
HPLC methods, complete method validations, are standard practice at Hovione.
Technical presentations, direct communication lines between Customer/Hovione
technical peers and regular visits are part of Customer Service.
Customers are encouraged to call, fax and e-mail Hovione technical people.
Naturally Hovione always welcomes customers to visit our facilities, allowing
them to audit or simple view the manufacturing process in person. Our job
is to find solutions for you.
An established network of agents and sales offices, presence at trade shows,
frequent and regular travel all over the World assures a good market coverage.
But coverage is not enough; an in-depth knowledge of local regulations and
players is just as important. A track-record of exporting to the most regulated
countries for over 40 years puts Hovione people on first name terms with
many of the key players in every country.
Hovione's strategy has been defined in response to Customer's needs. We
develop few products at a time, and as a result we have a short product
list. We invest massively in research and development in a single product
at one time, so that in the short term our Customers receive the best technical
support and can get approvals fast with minimum effort. In the long term,
Customers are assured a competitive supplier and a reliable source of bulk
product.
Our expertise in chemical synthesis and in meeting regulatory requirements
consistently helps our customers to reduce the time it takes to launch their
new products.
Hovione´s services include:
The full range of quantities
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From kilo to ton: at lab-scale,
at pilot-plant, and at industrial level. |
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From oral to parenteral; ton batch quantities
of injectable grade products, as well as sterile bulk; from milled
API for topical creams to controlled micronised particle size for
inhalation products. |
The full range of GMP production skills
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Producing kilos very fast, to
very tight time-lines |
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Scaling-up from a lab process
to a synthetic route suitable for cost-efficient industrial production
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Industrial scale manufacturing
in large cost-efficient batch size |
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Obtaining from FDA approval for
process, scale and site changes to meet capacity and efficiency targets
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The full range of regulatory and quality
services appropriate to obtaining approval by the health authorities (FDA,
EMEA, MCA, TGA, HPB, BphArM, etc…)
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Extensive experience in handling
submissions and related work for IND, NDA, AADA, ANDA, ANADA, DMF,
VMF, and a successful track-record in PAI. |
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We regularly participate in inter-laboratory
reference standard evaluations for USP; we supply USP and EP with
reference standards for substances and their impurities. A number
of analytical methods found in USP and EP have been contributed by
Hovione. |
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We develop and validate analytical methods.
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About Hovione 
50 Years of Generic APIs
