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01 2Faran Shimi Pharmaceutical

02 1Sanofi

03 7Dr. Reddy's Laboratories

04 4Rusan Pharma

05 9Ethypharm

06 1Mankind Pharma

07 4ABRAXIS PHARM

08 2Accord healthcare

09 5Actavis Inc

10 3Adapt Pharma

11 2Alkem Laboratories

12 4Alvogen

13 3Amneal Pharmaceuticals

14 5Amphastar Pharmaceuticals

15 1AstraZeneca

16 3Aurobindo Pharma Limited

17 4Austell Laboratories

18 3B. Braun Melsungen AG

19 1BPI Labs

20 2Baxter Healthcare Corporation

21 2Bharat Parenterals Limited

22 3BioDelivery Sciences

23 4Bluepharma

24 3Bristol Myers Squibb

25 1Chartwell Pharmaceuticals llc

26 4DIFGEN PHARMS

27 1Dong Bang Co., Ltd

28 4EG Spa

29 1ENDO OPERATIONS

30 3Emergent BioSolutions

31 4Farbe Firma

32 2Fresenius Kabi USA

33 2Fresenius SE & Co. KGaA

34 8GL Pharma

35 1Galenica MA

36 2Hameln Pharma GmbH

37 1Harm Reduction Therapeutics

38 14Hikma Pharmaceuticals

39 8Hospira, Inc.

40 12IGI Labs, Inc.

41 8Indivior

42 3Juno Pharmaceuticals Pty Ltd

43 3KALEO INC

44 2Lannett Company, Inc.

45 1Lupin Ltd

46 1MARSAM PHARMS LLC

47 5Mallinckrodt Pharmaceuticals

48 8Mepha Pharma

49 4Molteni Farmaceutici

50 26Mundipharma

51 3Omega Laboratories Limited

52 6Orexo

53 1Orpha-Devel Commercial und Court Of GmbH

54 1Orpha-Devel Handels und

55 1Padagis

56 1Par Sterile Products

57 3Pfizer Consumer Healthcare

58 1Pharma-Q Holdings (Pty) Ltd

59 3Phebra

60 3Pluviaendo

61 4Purdue Pharma

62 3Purdue Pharmaceuticals L.P

63 3Quad Pharma

64 1R Key Enterprises

65 2RHODES PHARMACEUTICALS LP

66 2Rising Pharmaceuticals Inc

67 1SALF SpA

68 2SIRTON MEDICARE Srl

69 3SMITH & NEPHEW INC

70 16Sandoz B2B

71 2Solo Pak

72 2Somerset Pharmaceuticals Inc

73 3Southern XP Pty Ltd

74 8Spirig Healthcare

75 1Sterinova Inc.

76 1Summit Biosciences

77 9Sun Pharmaceutical Industries Limited

78 5Teva Pharmaceutical Industries

79 2Verve Human Care Laboratories

80 11Viatris

81 2WES Pharma Inc

82 4Wyeth Pharmaceuticals Inc

83 1ZMI PHARMA

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PharmaCompass

01

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Interphex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Regulatory Info :

Registration Country : Iran

Buprenorphine; Naloxone

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 2MG; 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

Faran Shimi Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : DISCN

Registration Country : USA

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

Brand Name : TALWIN NX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-12-16

Application Number : 18733

Regulatory Info : DISCN

Registration Country : USA

Sanofi Company Banner

03

  • 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

04

  • 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

05

  • 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

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

Regulatory Info : RX

Registration Country : USA

NALOXONE HYDROCHLORIDE

Brand Name : NALOXONE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.4MG/ML

Packaging :

Approval Date : 2024-02-29

Application Number : 218404

Regulatory Info : RX

Registration Country : USA

Company Banner

07

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Interphex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Regulatory Info :

Registration Country : Iran

Buprenorphine; Naloxone

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 8MG; 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

Faran Shimi Pharmaceutical

08

  • 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

09

  • 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

10

  • 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

11

  • 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

12

  • 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

13

  • 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

NALOXONE HYDROCHLORIDE

Brand Name : NALOXONE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2020-03-16

Application Number : 213209

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

14

  • 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

15

  • 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

Naloxone Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 0.4mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

16

  • 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

Naloxone Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 0.4mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

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 : 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

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; Naloxone Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 2MG; 0.5MG

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 : France

Buprenorphine; Naloxone Hydrochloride

Brand Name :

Dosage Form : Sublingual Tablet

Dosage Strength : 8MG; 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

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 : France

Naloxone Hydrochloride

Brand Name :

Dosage Form : Pre-filled Syringe

Dosage Strength : 1MG/1ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

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

Oxycodone Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Prolong-release Tablet

Dosage Strength : 5MG; 2.5MG

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

Oxycodone Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Prolong-release Tablet

Dosage Strength : 10MG; 5MG

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

Oxycodone Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Prolong-release Tablet

Dosage Strength : 20MG; 10MG

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

Oxycodone Hydrochloride; Naloxone Hydrochloride

Brand Name :

Dosage Form : Prolong-release Tablet

Dosage Strength : 40MG; 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

25

Interphex
Not Confirmed
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Interphex
Not Confirmed

NALOXONE HYDROCHLORIDE

Brand Name : NARCAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 16636

Regulatory Info : DISCN

Registration Country : USA

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26

Interphex
Not Confirmed
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Interphex
Not Confirmed

NALOXONE HYDROCHLORIDE

Brand Name : NARCAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 16636

Regulatory Info : DISCN

Registration Country : USA

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27

Interphex
Not Confirmed
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Interphex
Not Confirmed

NALOXONE HYDROCHLORIDE

Brand Name : NARCAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-06-14

Application Number : 16636

Regulatory Info : DISCN

Registration Country : USA

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28

Interphex
Not Confirmed
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Oxycodoni hydrochloridum; Naloxoni hydrochloridum anhydricum

Brand Name : Oxycodone-Naloxone-Mepha

Dosage Form : Ret Tabl

Dosage Strength : 10mg/5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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29

Interphex
Not Confirmed
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Oxycodoni hydrochloridum; Naloxoni hydrochloridum anhydricum

Brand Name : Oxycodone-Naloxone-Mepha

Dosage Form : Ret Tabl

Dosage Strength : 10mg/5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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30

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Not Confirmed
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Oxycodoni hydrochloridum; Naloxoni hydrochloridum anhydricum

Brand Name : Oxycodone-Naloxone Sandoz

Dosage Form : Ret Tabl

Dosage Strength : 5mg/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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