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List of All Manufacturers & Suppliers of Focalin Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 8Granules India Limited

02 3ABHAI INC

03 8Adare Pharma Solutions

04 8Ajanta Pharma Limited

05 3Alkem Laboratories

06 8Aurolife Pharma LLC

07 2Bionpharma

08 3COMMAVE THERAP

09 8ENDO OPERATIONS

10 7Impax Laboratories

11 6Intellipharmaceutics Corporation

12 3Lannett Company, Inc.

13 2Neolpharma

14 3Novel Laboratories, Inc.

15 3RHODES PHARMACEUTICALS LP

16 19Sandoz B2B

17 11Sun Pharmaceutical Industries Limited

18 12Teva Pharmaceutical Industries

19 3Tris Pharma Inc

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 35MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

09

Pharmaconex 2024
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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2001-11-13

Application Number : 21278

Regulatory Info : RX

Registration Country : USA

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10

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2001-11-13

Application Number : 21278

Regulatory Info : RX

Registration Country : USA

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11

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2001-11-13

Application Number : 21278

Regulatory Info : RX

Registration Country : USA

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12

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2005-05-26

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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13

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2005-05-26

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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14

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2005-05-26

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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15

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2006-08-01

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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16

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2009-10-23

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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17

Pharmaconex 2024
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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2010-08-11

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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18

Pharmaconex 2024
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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 35MG

Packaging :

Approval Date : 2011-04-21

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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19

Pharmaconex 2024
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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2011-04-21

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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20

Pharmaconex 2024
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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2007-01-29

Application Number : 77107

Regulatory Info : DISCN

Registration Country : USA

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