Sartorius Stedim Biotech | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Sartorius Stedim Biotech
FDA

FAMAR CDMO- From early development to commercial manufacturing.

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Sartorius Stedim Biotech

VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 91 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
91 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

12 All APIs, 4 USDMF, 8 JDMF

12 All APIs
4 USDMF
8 JDMF

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

SERVICES

Analytical, API & Drug Product Development

Analytical
API & Drug Product Development
- 1 API Development

INSPECTIONS & REGISTRATIONS

5 FDA, 1 Third-Party Audit

5 FDA
1 Third-Party Audit

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FILTER :

filter Legal Name Reset all filters

5 All

01 4Sartorius Stedim Biooutsource Limited

02 1Sartorius Stedim North America, Inc.

filter District Decision Reset all filters

5 All

01 2No Action Indicated

02 3Voluntary Action Indicated

filter Inspection End Date Reset all filters

5 All

01 12023-06-23

02 12019-12-11

03 12019-03-06

04 12017-09-13

05 12016-01-26

filter City Reset all filters

5 All

01 1Cambridge

02 4Glasgow

filter Country/Area Reset all filters

5 All

01 1U.S.A

02 4United Kingdom

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01

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-06-23

Sartorius Stedim Biotech

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2142

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-06-23

Product
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Stock Recap
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Data Compilation
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02

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2019-12-11

Sartorius Stedim Biotech

City : Glasgow

State :

Country/Area : United Kingdom

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-12-11

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2019-03-06

Sartorius Stedim Biotech

City : Glasgow

State :

Country/Area : United Kingdom

Zip :

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-03-06

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04

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2017-09-13

Sartorius Stedim Biotech

City : Glasgow

State :

Country/Area : United Kingdom

Zip :

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2017-09-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

FDA Audited

USA

PEGS Boston Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2016-01-26

Sartorius Stedim Biotech

City : Glasgow

State :

Country/Area : United Kingdom

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2016-01-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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Contact Sartorius Stedim Biotech and get a quotation

Sartorius Stedim Biotech is a supplier offers 8 products (APIs, Excipients or Intermediates).

Find CIM CONVECTIVE INTERACTION MEDIA SDVB bulk with DMF offered by Sartorius Stedim Biotech

Find STERILIZING (0.1 µm, 0.2 µm) GRADE AND BIOBURDEN (0.45 µm) REDUCTION FILTERS bulk with DMF offered by Sartorius Stedim Biotech

Find 4CELL XTRACHO MEDIA SYSTEM bulk with DMF offered by Sartorius Stedim Biotech

Find Medium/medium additives: 4Cell XtraCHO Feed Medium B bulk with JDMF offered by Sartorius Stedim Biotech

Find Culture medium/medium supplements - 4Cell XtraCHO stock preparation and acclimation medium bulk with JDMF offered by Sartorius Stedim Biotech

Find Culture medium/culture medium additives ・4Cell XtraCHO production medium bulk with JDMF offered by Sartorius Stedim Biotech

Find Medium/medium additives: 4Cell XtraCHO Feed Medium A bulk with JDMF offered by Sartorius Stedim Biotech

Find FILTER MEMBRANE MATERIALS bulk offered by Sartorius Stedim Biotech

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