Contract Manufacturing
PharmaZell’s experience in manufacturing a very wide range of chemicals and API’s has developed over many decades and allows us now to quickly come up with solutions to virtually all types of chemical and other problems that we handle for our customers.
Click Here To Download:
•Brochure: Custom Synthesis
•Presentation: PharmaZell Overview
•Presentation: Continuous Processing
•Presentation: Custom Synthesis
PharmaZell’s experience in manufacturing a very wide range of chemicals and API’s has developed over many decades and allows us now to quickly come up with solutions to virtually all types of chemical and other problems that we handle for our customers.
Being able to develop and produce at different sites with different histories and different capabilities gives us the highest degree of flexibility in production. Multi-step synthesis’ can be worked on simultaneously at different sites which allows for the fastest possible new product introduction and - if one of our Indian sites is part of the supply chain - leads to economic advantages for both PharmaZell and our customer.
The wide range of technologies that the PharmaZell group has in its portfolio allows us to produce most of the known API’s. Also niche technologies such as electrolysis on a large scale and controlled substances are part of our knowhow. And, of course, we constantly enlarge our portfolio of technologies.
Site Raubling / Germany
Production follows GMP-standards (Good Manufacturing Practice) – as it is practiced in all PharmaZell locations. Regular inspections by the FDA and German authorities reflect the high standard of quality and regulatory compliance. Reliability regarding quality and timeline is of utmost importance at PharmaZell.
At the Raubling site, PharmaZell provides its customers with a wide range of services: production processes, customized active pharmaceutical ingredients, and analytical methods including all regulatory documents are all developed on-site by highly skilled employees.
Site Profile
COMPANY |
PharmaZell GmbH |
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Location |
Raubling (Germany) |
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Operation since |
1947 |
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Area (m²) |
33'780 m² |
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Headcount |
138 |
||
EQUIPMENT |
|
|
|
Reactors |
# |
Volume |
|
Total |
53 |
230 m³ |
|
Stainless Steel |
17 |
80 m³ |
|
Glass Lined |
28 |
110 m³ |
|
Other |
8 |
40 m³ |
|
Other Equipment |
# |
|
|
Centrifuges |
14 |
|
|
Nutsches |
3 |
|
|
Filter-Dryers |
0 |
|
|
Dryers |
5 |
|
|
Operating Ranges |
|
|
|
Temperature (min / max) |
-65 °C (min) |
200 °C (max) |
|
Pressure (min / max) |
3 mbar (min) |
10 bar (max) |
|
INFRASTRUCTURE |
|
|
|
Buildings |
# |
15 |
|
Biological Effluent Treatment Plant |
Yes |
||
TECHNOLOGIES |
|
|
|
Epichlorohydrin |
Electrochemistry |
|
|
Cryogenic reactions |
Nitration 100% Nitric Acid |
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Micronization |
Hydrogenation |
|
|
CERTIFICATIONS / APPROVALS |
|
|
|
|
FDA (since 1972) |
|
|
|
German Health Authority |
Site Copenhagen / Denmark
As the site used to be key in the development of formulations for its parent company prior to the acquisition by PharmaZell there is still a vast amount of knowhow on site available which can be tapped into if customers require assistance in their formulation needs. The site itself has stopped its formulation activities, as it is not part of the core business anymore.
Site Profile
COMPANY |
Pharmazell Denmark A/S |
|
Location |
CPH (Denmark) |
|
Operation since |
1930 |
|
Area (m²) |
20'705 m² |
|
Headcount |
44 |
|
EQUIPMENT |
|
|
Reactors |
# |
Volume |
Total |
16 |
30 m³ |
Stainless Steel |
7 |
19 m³ |
Glass Lined |
9 |
11 m³ |
Other |
0 |
0 m³ |
Other Equipment |
# |
|
Centrifuges |
0 |
|
Nutsches |
1 |
|
Filter-Dryers |
4 |
0,05 - 4 m² |
Dryers |
2 |
|
Operating Ranges |
|
|
Temperature (min / max) |
-40 °C (min) |
180 °C (max) |
Pressure (min / max) |
3 mbar (min) |
5 bar (max) |
INFRASTRUCTURE |
|
|
Buildings |
# |
4 |
Biological Effluent Treatment Plant |
-- |
|
TECHNOLOGIES |
|
|
Controlled Substances |
Hydrogenation |
|
Sodium Hydride |
Chlorosulfonation |
|
Complex hydride reductions |
Palladium coupling |
|
Grignard |
Phosphorylation |
|
CERTIFICATIONS / APPROVALS |
|
|
|
Danish Health Authority |
Site Vizag / India
PharmaZell (Vizag) Pv. Ltd. was founded as a greenfield site in 2007 when construction started in the Special Economic Zone of the Jawaharlal Nehru Pharma City, a new large industrial estate exclusively for the pharmaceutical industry. The new PharmaZell production site was designed such that all infrastructure and utilities are available to support future expansion project with many more production blocks. The site was officially opened in October 2008 just after the first audit by the German Health Authority.
The first production building to go on stream was built for manufacturing Mesalamine following the same process as used at the Raubling site. The fully automated state-of-the-art production plant ensures consistently highest GMP and quality standards.
In 2009 a new small scale production unit was commissioned predominantly for small volumes of generic API’s. In this production unit wide temperature and pressure ranges can be handled.
Currently a second small scale production unit with larger reactors is under construction and will be completed early 2011.
Site Profile
COMPANY |
PharmaZell (Vizag) Pv. Ltd. |
|
Location |
Vizag (India) |
|
Operation since |
2008 |
|
Area (m²) |
67.708 m² |
|
Headcount |
72 |
|
EQUIPMENT |
|
|
Reactors |
# |
Volume |
Total |
16 |
56 m³ |
Stainless Steel |
4 |
1 m³ |
Glass Lined |
7 |
33 m³ |
Other |
5 |
22 m³ |
Other Equipment |
# |
|
Centrifuges |
3 |
|
Nutsches |
4 |
|
Filter-Dryers |
1 |
|
Dryers |
5 |
|
Operating Ranges |
|
|
Temperature (min / max) |
-70 °C (min) |
250 °C (max) |
Pressure (min / max) |
1 mbar (min) |
40 bar (max) |
INFRASTRUCTURE |
|
|
Buildings |
# |
7 |
Biological Effluent Treatment Plant |
-- |
|
TECHNOLOGIES |
|
|
|
Electrochemistry |
|
|
Hydrogenation |
|
|
Cryogenic reactions |
|
CERTIFICATIONS / APPROVALS |
|
|
|
German Health Authority |
Site Chennai / India
PharmaZell (India) Pv. Ltd. was constructed as a greenfield site in 1995 in the Special Economic Zone of the Madras Export Processing Zone (MEPZ). It was initially built as a 100% affiliate of the German site to produce amino acids and their derivatives using water based chemistry only.
Due to its location close to the International Airport of Chennai and one of the largest harbors of India as well as easy access to a pool of well trained people of the mega polis of Chennai the site, however, has developed hugely since then and handles now a wide range of chemistry on an area three times as large as at the beginning. It is definitely one of the key pillars in the PharmaZell group manufacturing products from smallest scale in the kilo lab up to products with many hundreds of tons.
Site Profile
COMPANY |
PharmaZell (India) Pv. Ltd. |
|
Location |
Chennai (India) |
|
Operation since |
1995 |
|
Area (m²) |
21.115 m² |
|
Headcount |
214 |
|
EQUIPMENT |
|
|
Reactors |
# |
Volume |
Total |
38 |
129 m³ |
Stainless Steel |
11 |
42 m³ |
Glass Lined |
25 |
86 m³ |
Other |
2 |
2 m³ |
Other Equipment |
# |
|
Centrifuges |
15 |
|
Nutsches |
|
|
Filter-Dryers |
1 |
|
Dryers |
12 |
|
Operating Ranges |
|
|
Temperature (min / max) |
-15 °C (min) |
120 °C (max) |
Pressure (min / max) |
10 mbar (min) |
6 bar (max) |
INFRASTRUCTURE |
|
|
Buildings |
# |
10 |
Biological Effluent Treatment Plant |
Yes |
|
TECHNOLOGIES |
|
|
|
Electrochemistry |
|
|
Hydrogenation |
|
CERTIFICATIONS / APPROVALS |
|
|
|
FDA |
|
|
German Health Authority |
|
|
Pharmaceuticals and Medical Devices Agency Japan (PMDA) |
Click Here To Download:
•Brochure: Custom Synthesis
•Presentation: PharmaZell Overview
•Presentation: Continuous Processing
•Presentation: Custom Synthesis