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01 2ADVANZ PHARMA CANADA INC.

02 2Advanz Pharma

03 2Apotex Inc

04 3Chiesi Australia

05 3Intas Pharmaceuticals

06 2Intercept Pharma Ltd.

07 2Intercept Pharmaceuticals

08 2Lupin Ltd

09 2MSN Laboratories

10 1Optimus Pharma

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PharmaCompass

01

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Acidum obeticholicum

Brand Name : Ocaliva

Dosage Form : Film-Coated Tablets

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Acidum obeticholicum

Brand Name : Ocaliva

Dosage Form : Film-Coated Tablets

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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04

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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05

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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11

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : RX

Registration Country : USA

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12

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : RX

Registration Country : USA

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13

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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14

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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15

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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16

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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17

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET; ORAL

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number : 214935

Regulatory Info :

Registration Country : USA

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18

Intercept Pharma Ltd.

Country
CPhI India 2024
Not Confirmed
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Intercept Pharma Ltd.

Country
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CPhI India 2024
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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19

Intercept Pharma Ltd.

Country
CPhI India 2024
Not Confirmed
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Intercept Pharma Ltd.

Country
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CPhI India 2024
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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20

ADVANZ PHARMA CANADA INC.

Country
CPhI India 2024
Not Confirmed
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ADVANZ PHARMA CANADA INC.

Country
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2463121

Regulatory Info : Prescription

Registration Country : Canada

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21

ADVANZ PHARMA CANADA INC.

Country
CPhI India 2024
Not Confirmed
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ADVANZ PHARMA CANADA INC.

Country
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CPhI India 2024
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2463148

Regulatory Info : Prescription

Registration Country : Canada

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