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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shanghai Kyowa Amino Acid Co., Ltd.

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01 Amino Acids Mixture (1)

02 Aspartic Acid API (1)

03 Isoleucine (1)

04 L-Alanine API (1)

05 L-Arginine Hydrochloride API (2)

06 L-Histidine (2)

07 L-Leucine API (1)

08 L-Lysine Hydrochloride (1)

09 L-Threonine (1)

10 L-VALINE (1)

11 Phenylalanine (1)

12 Proline (1)

13 Serine (1)

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01 Active (1)

02 Blank (14)

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01 Valid (14)

02 Blank (1)

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01 Blank (15)

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01 Blank (15)

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USDMF

Found USDMF

32088
Active
AMINO ACIDS
2017-09-08
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
32088
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
AMINO ACIDS
Issue/Submission Date
2017-09-08
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2007-353 - Rev 00
Valid
Aspartic Acid
2018-04-26
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Aspartic Acid
Issue/Submission Date
2018-04-26
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-188 - Rev 00
Valid
Isoleucine
2017-02-08
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Isoleucine
Issue/Submission Date
2017-02-08
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2007-351 - Rev 01
Valid
Alanine
2023-01-12
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Alanine
Issue/Submission Date
2023-01-12
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-045 - Rev 00
Valid
Arginine
2017-02-20
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Arginine
Issue/Submission Date
2017-02-20
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-048 - Rev 00
Valid
Arginine hydrochloride
2017-02-20
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Arginine hydrochloride
Issue/Submission Date
2017-02-20
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USDMF

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CEP/COS

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R1-CEP 2010-047 - Rev 01
Valid
Histidine Hydrochloride Monohydrate
2017-06-01
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Histidine Hydrochloride Monohydrate
Issue/Submission Date
2017-06-01
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-046 - Rev 01
Valid
Histidine
2017-04-28
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Histidine
Issue/Submission Date
2017-04-28
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-189 - Rev 00
Valid
Leucine
2017-01-31
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Leucine
Issue/Submission Date
2017-01-31
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2012-007 - Rev 00
Valid
Lysine Hydrochloride
2018-03-01
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Lysine Hydrochloride
Issue/Submission Date
2018-03-01
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