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Bora CDMO Bora CDMO

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apex Healthcare Limited

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01 Alendronate Sodium (2)

02 Benzocaine (2)

03 Bisacodyl (2)

04 Cetirizine Dihydrochloride (1)

05 Lidocaine (2)

06 Lidocaine Hydrochloride (2)

07 Lornoxicam (2)

08 Meloxicam (2)

09 Phenyramidol Hydrochloride (2)

10 Piroxicam (2)

11 Piroxicam-Beta-Cyclodextrin (2)

12 Prilocaine (2)

13 Prilocaine Hydrochloride (2)

14 Sodium Picosulfate (2)

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01 Active (6)

02 Inactive (1)

03 Blank (20)

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01 Valid (3)

02 Blank (24)

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01 Blank (27)

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01 WC-0409 (11)

02 WC-0409A2 (3)

03 WC-0409n (13)

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USDMF

Found USDMF

36841
Active
PIROXICAM USP
2022-02-25
CEP/COS

Found CEP/COS

CEP 2021-358 - Rev 00
Valid
Piroxicam
2024-03-20
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Piroxicam BP/EP/USP
2021-03-19
Application Number
36841
Indian CDSCO WC-0409n
Status
Active
Fees Unpaid
N/A
Valid
 
Expired
2023-12-31
Filing Details
PIROXICAM USP
Piroxicam
Piroxicam BP/EP/USP
Issue/Submission Date
2022-02-25
2024-03-20
2021-03-19
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USDMF

Caution USDMF

34196
Inactive
BENZOCAINE USP
2019-10-16
CEP/COS

Found CEP/COS

R0-CEP 2022-102 - Rev 00
Valid
Benzocaine
2023-08-09
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Benzocaine BP/EP/USP
2021-03-19
Application Number
34196
Indian CDSCO WC-0409n
Status
Inactive
Fees Unpaid
N/A
Valid
 
Expired
2023-12-31
Filing Details
BENZOCAINE USP
Benzocaine
Benzocaine BP/EP/USP
Issue/Submission Date
2019-10-16
2023-08-09
2021-03-19
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USDMF

Found USDMF

36766
Active
BENZOCAINE USP
2022-02-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409A2
Expired
Benzocaine (BP/EP)
2019-12-03
Application Number
36766
Indian CDSCO WC-0409A2
Status
Active
Fees Unpaid
N/A
 
Expired
2020-12-31
Filing Details
BENZOCAINE USP
Benzocaine (BP/EP)
Issue/Submission Date
2022-02-03
2019-12-03
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USDMF

Found USDMF

36474
Active
BISACODYL USP
2022-01-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Bisacodyl BP/EP/USP
2021-03-19
Application Number
36474
Indian CDSCO WC-0409n
Status
Active
Fees Unpaid
N/A
 
Expired
2023-12-31
Filing Details
BISACODYL USP
Bisacodyl BP/EP/USP
Issue/Submission Date
2022-01-27
2021-03-19
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USDMF

Found USDMF

34109
Active
LIDOCAINE USP
2019-09-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Lidocaine BP/EP/USP
2021-03-19
Application Number
34109
Indian CDSCO WC-0409n
Status
Active
Fees Unpaid
N/A
 
Expired
2023-12-31
Filing Details
LIDOCAINE USP
Lidocaine BP/EP/USP
Issue/Submission Date
2019-09-21
2021-03-19
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USDMF

Found USDMF

34307
Active
LIDOCAINE HYDROCHLORIDE USP
2020-12-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Lidocaine HCl BP/EP/USP
2021-03-19
Application Number
34307
Indian CDSCO WC-0409n
Status
Active
Fees Unpaid
N/A
 
Expired
2023-12-31
Filing Details
LIDOCAINE HYDROCHLORIDE USP
Lidocaine HCl BP/EP/USP
Issue/Submission Date
2020-12-15
2021-03-19
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USDMF

Found USDMF

39139
Active
LIDOCAINE HYDROCHLORIDE USP
2023-12-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409
Expired
Lidocaine Hydrochloride (BP/EP/USP)
2018-01-01
Application Number
39139
Indian CDSCO WC-0409
Status
Active
Fees Unpaid
N/A
 
Expired
2021-01-01
Filing Details
LIDOCAINE HYDROCHLORIDE USP
Lidocaine Hydrochloride (BP/EP/USP)
Issue/Submission Date
2023-12-01
2018-01-01
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2016-061 - Rev 00
Valid
Meloxicam
2023-05-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Meloxicam BP/EP/USP
2021-03-19
Application Number
Indian CDSCO WC-0409n
Status
Valid
 
Expired
2023-12-31
Filing Details
Meloxicam
Meloxicam BP/EP/USP
Issue/Submission Date
2023-05-17
2021-03-19
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409n
Expired
Sodium alendronate BP/EP/USP
2021-03-19
Application Number
Indian CDSCO WC-0409n
Status
 
Expired
2023-12-31
Filing Details
Sodium alendronate BP/EP/USP
Issue/Submission Date
2021-03-19
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0409
Expired
Sodium Alendronate (BP/EP/USP)
2018-01-01
Application Number
Indian CDSCO WC-0409
Status
 
Expired
2021-01-01
Filing Details
Sodium Alendronate (BP/EP/USP)
Issue/Submission Date
2018-01-01
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