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    FAMAR CDMO- From early development to commercial manufacturing.

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    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Together we can improve the quality of life

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    Labetalol

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    01 7Aspen Pharmacare Holdings

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    01

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 18/12/1981

    Application Number : 19811218000021

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 18/12/1981

    Application Number : 19811218000038

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 5mg/ml

    Packaging :

    Approval Date : 18/12/1981

    Application Number : 19811218000045

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 100mg/20ml

    Packaging :

    Approval Date : 23/10/1979

    Application Number : 41529

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    05

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05/12/1978

    Application Number : 41530

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    06

    Aspen Pharmacare Holdings

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 05/12/1978

    Application Number : 41530

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    07

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Originator

    Registration Country : South Africa

    Labetalol Hydrochloride

    Brand Name : Trandate Injection

    Dosage Form : INJ

    Dosage Strength : 5mg/1ml

    Packaging : 20X5mg/1ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    08

    Alvogen

    U.S.A
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    Alvogen

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1985-05-24

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Alvogen

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Alvogen

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    11

    Alvogen

    U.S.A
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    Alvogen

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Bayer AG

    Germany
    IPPE
    Not Confirmed
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    Bayer AG

    Germany
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18686

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Bayer AG

    Germany
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    Bayer AG

    Germany
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1987-08-31

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Bayer AG

    Germany
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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    Bayer AG

    Germany
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    Bayer AG

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    Regulatory Info : DISCN

    Registration Country : USA

    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    16

    Bayer AG

    Germany
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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    17

    Bayer AG

    Germany
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    Regulatory Info : DISCN

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;100MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Bayer AG

    Germany
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    Regulatory Info : DISCN

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;200MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Bayer AG

    Germany
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    Regulatory Info : DISCN

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;300MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    Bayer AG

    Germany
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    Regulatory Info : DISCN

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;400MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.