Product/Service

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.

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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

Location

Raubling (Germany)

Operation since

1947

Area (m²)

33'780 m²

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

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