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01 6Dr. Reddy's Laboratories

02 6Rusan Pharma

03 14Ethypharm

04 7Actavis Inc

05 3Activase Pharmaceuticals Limited

06 4Adcock Ingram

07 2Alkem Laboratories

08 11Alvogen

09 1American Regent

10 2Amneal Pharmaceuticals

11 2Barr Laboratories

12 10BioDelivery Sciences

13 3Bluefish Pharmaceuticals AB

14 1CEVA ANIMAL HEALTH INC

15 2DIFGEN PHARMS

16 1ENDO OPERATIONS

17 2Eumedica Pharmaceuticals

18 3GL Pharma

19 5Hikma Pharmaceuticals

20 1Hospira, Inc.

21 30Indivior

22 2L Molteni & C Dei F.LLI

23 2Lannett Company, Inc.

24 2Mallinckrodt Pharmaceuticals

25 2Martindale Pharmaceuticals Ltd.

26 1Medartuum AB

27 2NORVIUM BIOSCIENCE

28 3ORIFARM GROUP AS

29 6Orexo

30 4Pharmascience Inc.

31 1R Key Enterprises

32 1REACX PHARMS

33 4RHODES PHARMACEUTICALS LP

34 2Rubicon Research

35 2Sandoz B2B

36 10Sun Pharmaceutical Industries Limited

37 10Teva Pharmaceutical Industries

38 1VetViva Richter

39 4Viatris

40 2WES Pharma Inc

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : FILM;BUCCAL, SUBLINGUAL

Dosage Strength : EQ 2MG BASE;EQ 0.5MG BASE

Packaging :

Approval Date : 2018-06-14

Application Number : 205299

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 2MG; 0.5MG

Packaging : Pack Size 10x10; 1x7; 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2MG BASE

Packaging :

Approval Date : 2010-09-24

Application Number : 90622

Regulatory Info : RX

Registration Country : USA

Ethypharm

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : FILM;BUCCAL, SUBLINGUAL

Dosage Strength : EQ 8MG BASE;EQ 2MG BASE

Packaging :

Approval Date : 2018-06-14

Application Number : 205299

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : FILM;BUCCAL, SUBLINGUAL

Dosage Strength : EQ 4MG BASE;EQ 1MG BASE

Packaging :

Approval Date : 2018-06-14

Application Number : 205806

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : FILM;BUCCAL, SUBLINGUAL

Dosage Strength : EQ 12MG BASE;EQ 3MG BASE

Packaging :

Approval Date : 2018-06-14

Application Number : 205806

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : DISCN

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2MG BASE;EQ 0.5MG BASE

Packaging :

Approval Date : 2020-07-17

Application Number : 206953

Regulatory Info : DISCN

Registration Country : USA

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : DISCN

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 8MG BASE;EQ 2MG BASE

Packaging :

Approval Date : 2020-07-17

Application Number : 206953

Regulatory Info : DISCN

Registration Country : USA

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 8MG; 2MG

Packaging : Pack Size 10x10; 1x7; 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 0.2mg

Packaging : Pack Size 5x20; 1x7; 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 0.4mg

Packaging : Pack Size 3x10; 1x7; 1x10; 5x20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

12

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 2mg

Packaging : Pack Size 4x7; 10x10; 1x7; 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

13

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 8mg

Packaging : Pack Size 4x7; 10x10; 1x7; 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 8MG BASE

Packaging :

Approval Date : 2010-09-24

Application Number : 90622

Regulatory Info : RX

Registration Country : USA

Ethypharm

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2MG BASE;EQ 0.5MG BASE

Packaging :

Approval Date : 2015-10-16

Application Number : 204431

Regulatory Info : RX

Registration Country : USA

Ethypharm

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info : RX

Registration Country : USA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 8MG BASE;EQ 2MG BASE

Packaging :

Approval Date : 2015-10-16

Application Number : 204431

Regulatory Info : RX

Registration Country : USA

Ethypharm

17

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Oral Lyophilizate

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

18

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Oral Lyophilizate

Dosage Strength : 8MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

19

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : Norway

Buprenorphine Hydrochloride

Brand Name : Espranor

Dosage Form : Lyofilisattablett

Dosage Strength : 8 mg

Packaging : Endose blister pack 7 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Ethypharm

20

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : Norway

Buprenorphine Hydrochloride

Brand Name : Espranor

Dosage Form : Lyofilisattablett

Dosage Strength : 2 mg

Packaging : Endose blister pack 7 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Ethypharm

21

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 0.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

22

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

23

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

24

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

25

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 6MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

26

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Buprenorphine Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 8MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

27

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

BUPRENORPHINE HYDROCHLORIDE

Brand Name : BUPRENEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 18401

Regulatory Info : DISCN

Registration Country : USA

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28

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

BUPRENORPHINE HYDROCHLORIDE

Brand Name : SUBUTEX

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-10-08

Application Number : 20732

Regulatory Info : DISCN

Registration Country : USA

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29

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

BUPRENORPHINE HYDROCHLORIDE

Brand Name : SUBUTEX

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-10-08

Application Number : 20732

Regulatory Info : DISCN

Registration Country : USA

blank

30

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand Name : SUBOXONE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-10-08

Application Number : 20733

Regulatory Info : DISCN

Registration Country : USA

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