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Bora CDMO Bora CDMO

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sol S.p.a Group

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01 Nitric Oxide (1)

02 Nitrogen (2)

03 Oxygen (1)

04 Blank (2)

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01 Blank (6)

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01 Valid (6)

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01 Blank (6)

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01 Blank (6)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2014-103 - Rev 00
Valid
Nitric oxide
2020-05-26
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Nitric oxide
Issue/Submission Date
2020-05-26
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2014-311 - Rev 00
Valid
Nitrogen, low-oxygen
2021-03-10
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Nitrogen, low-oxygen
Issue/Submission Date
2021-03-10
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2014-312 - Rev 00
Valid
Nitrogen
2021-03-10
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Nitrogen
Issue/Submission Date
2021-03-10
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2020-295 - Rev 00
Valid
Oxygen
2021-05-10
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Oxygen
Issue/Submission Date
2021-05-10
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Oxygen, Verona site

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USDMF

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CEP/COS

Found CEP/COS

CEP 2023-184 - Rev 00
Valid
Oxygen, Verona site
2024-03-05
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Oxygen, Verona site
Issue/Submission Date
2024-03-05
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Oxygen, Mantova site

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USDMF

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CEP/COS

Found CEP/COS

CEP 2023-162 - Rev 00
Valid
Oxygen, Mantova site
2024-03-06
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Oxygen, Mantova site
Issue/Submission Date
2024-03-06
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