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01 3Allergan Aesthetics

02 3Breckenridge Pharmaceutical

03 3Alembic Pharmaceuticals Limited

04 3Hisamitsu Pharmaceutical Co., Inc.

05 2Kwality Pharmaceuticals

06 2N.V. Organon Kloosterstraat -

07 2ORGANON CANADA INC.

08 8Organon

09 2Sigmapharm Laboratories, LLC

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PharmaCompass

01

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : SAPHRIS

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2009-08-13

Application Number : 22117

Regulatory Info : RX

Registration Country : USA

Abbvie CB

02

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 205960

Regulatory Info : RX

Registration Country : USA

Breckenridge Pharmaceutical

03

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : SAPHRIS

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2009-08-13

Application Number : 22117

Regulatory Info : RX

Registration Country : USA

Abbvie CB

04

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : SAPHRIS

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2015-03-12

Application Number : 22117

Regulatory Info : RX

Registration Country : USA

Abbvie CB

05

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 205960

Regulatory Info : RX

Registration Country : USA

Breckenridge Pharmaceutical

06

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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2021-03-08

Application Number : 205960

Regulatory Info : RX

Registration Country : USA

Breckenridge Pharmaceutical

07

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 206098

Regulatory Info : RX

Registration Country : USA

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08

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 206098

Regulatory Info : RX

Registration Country : USA

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09

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2021-07-19

Application Number : 206098

Regulatory Info : RX

Registration Country : USA

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10

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE

Brand Name : SECUADO

Dosage Form : SYSTEM;TRANSDERMAL

Dosage Strength : 3.8MG/24HR

Packaging :

Approval Date : 2019-10-11

Application Number : 212268

Regulatory Info : RX

Registration Country : USA

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11

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE

Brand Name : SECUADO

Dosage Form : SYSTEM;TRANSDERMAL

Dosage Strength : 5.7MG/24HR

Packaging :

Approval Date : 2019-10-11

Application Number : 212268

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

ASENAPINE

Brand Name : SECUADO

Dosage Form : SYSTEM;TRANSDERMAL

Dosage Strength : 7.6MG/24HR

Packaging :

Approval Date : 2019-10-11

Application Number : 212268

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

Asenapine Maleate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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14

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Asenapine Maleate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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15

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

asenapinmaleat

Brand Name : Sycrest

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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16

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

asenapinmaleat

Brand Name : Sycrest

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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17

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Asenapina 10Mg 60 Units Sublingual Use

Dosage Strength : 60 sublingual cpr 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Asenapina 5Mg 60 Units Sublingual Use

Dosage Strength : 60 sublingual CPR 5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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19

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Subling Tabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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20

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Subling Tabl

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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21

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

asenapine

Brand Name : Saphris

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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22

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

asenapine

Brand Name : Saphris

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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23

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 206107

Regulatory Info : RX

Registration Country : USA

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24

CPhI India 2024
Not Confirmed
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CPhI India 2024
Not Confirmed

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-12-10

Application Number : 206107

Regulatory Info : RX

Registration Country : USA

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25

N.V. Organon Kloosterstraat -

Country
CPhI India 2024
Not Confirmed
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N.V. Organon Kloosterstraat -

Country
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Sublingvaltablett

Dosage Strength : 10 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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26

N.V. Organon Kloosterstraat -

Country
CPhI India 2024
Not Confirmed
arrow

N.V. Organon Kloosterstraat -

Country
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CPhI India 2024
Not Confirmed

Asenapine

Brand Name : Sycrest

Dosage Form : Sublingvaltablett

Dosage Strength : 5 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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27

ORGANON CANADA INC.

Country
CPhI India 2024
Not Confirmed
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ORGANON CANADA INC.

Country
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CPhI India 2024
Not Confirmed

ASENAPINE (ASENAPINE MALEATE)

Brand Name : SAPHRIS

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging : 20/60

Approval Date :

Application Number : 2374803

Regulatory Info : Prescription

Registration Country : Canada

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28

ORGANON CANADA INC.

Country
CPhI India 2024
Not Confirmed
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ORGANON CANADA INC.

Country
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CPhI India 2024
Not Confirmed

ASENAPINE (ASENAPINE MALEATE)

Brand Name : SAPHRIS

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging : 20/60

Approval Date :

Application Number : 2374811

Regulatory Info : Prescription

Registration Country : Canada

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