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Also known as: 124-90-3, Oxycodone hcl, Oxecta, Oxycontin, Endocodone, Roxicodone
Molecular Formula
C18H22ClNO4
Molecular Weight
351.8  g/mol
InChI Key
MUZQPDBAOYKNLO-RKXJKUSZSA-N
FDA UNII
C1ENJ2TE6C

Oxycodone Hydrochloride
A semisynthetic derivative of CODEINE.
1 2D Structure

Oxycodone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
2.1.2 InChI
InChI=1S/C18H21NO4.ClH/c1-19-8-7-17-14-10-3-4-12(22-2)15(14)23-16(17)11(20)5-6-18(17,21)13(19)9-10;/h3-4,13,16,21H,5-9H2,1-2H3;1H/t13-,16+,17+,18-;/m1./s1
2.1.3 InChI Key
MUZQPDBAOYKNLO-RKXJKUSZSA-N
2.1.4 Canonical SMILES
CN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)OC)O4)O.Cl
2.1.5 Isomeric SMILES
CN1CC[C@]23[C@@H]4C(=O)CC[C@]2([C@H]1CC5=C3C(=C(C=C5)OC)O4)O.Cl
2.2 Other Identifiers
2.2.1 UNII
C1ENJ2TE6C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dihydrohydroxycodeinone

2. Dihydrone

3. Dinarkon

4. Eucodal

5. Oxiconum

6. Oxycodeinon

7. Oxycodone

8. Oxycone

9. Oxycontin

10. Pancodine

11. Theocodin

2.3.2 Depositor-Supplied Synonyms

1. 124-90-3

2. Oxycodone Hcl

3. Oxecta

4. Oxycontin

5. Endocodone

6. Roxicodone

7. Oxycodone Hydrochloride Cii

8. Chebi:7859

9. 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

10. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

11. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydron;chloride

12. Roxicodone (tn)

13. Oxycontin (tn)

14. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

15. Oxecta (tn)

16. Roxybond

17. Oxycodone Monohydrochloride

18. Schembl30095

19. Oxycodone Hydrochloride (usp)

20. Chembl1200890

21. Dtxsid80924674

22. Oxycodone Hydrochloride [mi]

23. Oxycodone Hydrochloride [usan]

24. Akos024457896

25. Oxycodone Hydrochloride [mart.]

26. Oxycodone Hydrochloride [vandf]

27. Anhydrous Oxycodone Hydrochloride

28. Oxycodone Hydrochloride [who-dd]

29. Oxycodone Hydrochloride, Analytical Standard

30. Oxycodone Hydrochloride [orange Book]

31. Oxycodone Hydrochloride Cii [usp-rs]

32. Oxycodone Hydrochloride [ep Monograph]

33. Tylox Component Oxycodone Hydrochloride

34. C08026

35. Codoxy Component Oxycodone Hydrochloride

36. D00847

37. Oxycet Component Oxycodone Hydrochloride

38. Oxycodone Hydrochloride [usp Monograph]

39. Roxicet Component Oxycodone Hydrochloride

40. Roxilox Component Oxycodone Hydrochloride

41. Troxyca Component Oxycodone Hydrochloride

42. Combunox Component Oxycodone Hydrochloride

43. Oxycodone Hydrochloride Component Of Tylox

44. Percocet Component Oxycodone Hydrochloride

45. Percodan Component Oxycodone Hydrochloride

46. Roxiprin Component Oxycodone Hydrochloride

47. Targiniq Component Oxycodone Hydrochloride

48. Xartemis Component Oxycodone Hydrochloride

49. Oxycodone Hydrochloride Component Of Codoxy

50. Oxycodone Hydrochloride Component Of Oxycet

51. Oxycodone Hydrochloride Component Of Roxicet

52. Oxycodone Hydrochloride Component Of Roxilox

53. Oxycodone Hydrochloride Component Of Troxyca

54. Oxycodone Hydrochloride Component Of Combunox

55. Oxycodone Hydrochloride Component Of Percocet

56. Oxycodone Hydrochloride Component Of Percodan

57. Oxycodone Hydrochloride Component Of Roxiprin

58. Oxycodone Hydrochloride Component Of Targiniq

59. Oxycodone Hydrochloride Component Of Xartemis

60. Percodan-demi Component Oxycodone Hydrochloride

61. Q27107601

62. Oxycodone Hydrochloride Component Of Percodan-demi

63. 14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one Hydrochloride

64. Oxycodone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

65. Oxycodone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

66. (5?)-4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

67. (5alpha,17s)-14-hydroxy-3-methoxy-17-methyl-6-oxo-4,5-epoxymorphinan-17-ium Chloride

68. 4,5.alpha.-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

69. Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, Hydrochloride, (5.alpha.)-

70. Oxycodone Hydrochloride Solution, 1.0 Mg/ml In Methanol, Analytical Standard, For Drug Analysis

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 351.8 g/mol
Molecular Formula C18H22ClNO4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count1
Exact Mass351.1237359 g/mol
Monoisotopic Mass351.1237359 g/mol
Topological Polar Surface Area59 Ų
Heavy Atom Count24
Formal Charge0
Complexity553
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameOxecta
Drug LabelOXECTA (oxycodone HCl, USP) tablets are an immediate-release opioid analgesic intended for oral administration only. OXECTA contains oxycodone HCl, USP as the active analgesic ingredient. The tablets are round, convex, white and debossed with the str...
Active IngredientOxycodone hydrochloride
Dosage FormTablet
RouteOral
Strength7.5mg; 5mg
Market StatusPrescription
CompanyAcura Pharms

2 of 4  
Drug NameOxycodone hydrochloride
Drug LabelDESCRIPTIONOxyContin (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration...
Active IngredientOxycodone hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule; Solution
Routeoral; Oral
Strength30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyCorepharma; Vintage Pharms; Amneal Pharms; Impax Pharms; Aurolife Pharma; Avanthi; Teva; Endo Pharms; Sun Pharm Inds; Coastal Pharms; Rhodes Pharms; Mallinckrodt; Roxane; Lannett Holdings; Nesher Pharms; Vistapharm; Actavis Elizabeth; Lehigh Valley; Alvog

3 of 4  
Drug NameOxecta
Drug LabelOXECTA (oxycodone HCl, USP) tablets are an immediate-release opioid analgesic intended for oral administration only. OXECTA contains oxycodone HCl, USP as the active analgesic ingredient. The tablets are round, convex, white and debossed with the str...
Active IngredientOxycodone hydrochloride
Dosage FormTablet
RouteOral
Strength7.5mg; 5mg
Market StatusPrescription
CompanyAcura Pharms

4 of 4  
Drug NameOxycodone hydrochloride
Drug LabelDESCRIPTIONOxyContin (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration...
Active IngredientOxycodone hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule; Solution
Routeoral; Oral
Strength30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyCorepharma; Vintage Pharms; Amneal Pharms; Impax Pharms; Aurolife Pharma; Avanthi; Teva; Endo Pharms; Sun Pharm Inds; Coastal Pharms; Rhodes Pharms; Mallinckrodt; Roxane; Lannett Holdings; Nesher Pharms; Vistapharm; Actavis Elizabeth; Lehigh Valley; Alvog

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)


Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

API SUPPLIERS

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DMF Review : N/A

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DMF Review : Complete

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Veranova

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Oxycodone Hydrochloride

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
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Oxycodone Hydrochloride

About the Company : Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds th...

Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds the distinction of being the second private sector company in Iran to obtain a license from the Food and Drug Organization to manufacture narcotic products. Leveraging opioid raw materials, Parand Daro has successfully produced potent medicinal substances, including codeine phosphate, noscapine, thebaine, papaverine and oxycodone. Apart from catering to domestic demand, Parand Daro has also expanded its reach by exporting its products to global markets.
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Oxycodone Hydrochloride

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Temad Co

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Oxycodone Hydrochloride

About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.
Temad

05

EUROAPI

France
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Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Oxycodone Hydrochloride

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.
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06

Rusan Pharma

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

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Oxycodone Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
Rusan Pharma

07

Noramco

U.S.A
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Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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Oxycodone Hydrochloride

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
Noramco

08

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Oxycodone

About the Company : Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to us...

Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to use pharmaceutical dosage forms. The company is known as the pioneer generic producer for new entities and ready to use pharmaceutical formulations made by research and production units. It has created a production line for anticancer active ingredients in Baran Chemical and Pharmaceutical Co., molecules in low quantity with high value such as Fingolimod, Nitisinone, Bosentan, etc.
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09

ITALTECNO

Italy
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ITALTECNO

Italy
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Oxycodone

About the Company : We are an Italian company that import and export goods and services to all around the world. Our target is to obtain the best quality goods and services to satisfy the requirements...

We are an Italian company that import and export goods and services to all around the world. Our target is to obtain the best quality goods and services to satisfy the requirements of the client and to provide them as quickly as possible. Furthermore, we aim to provide a comprehensive “one-stop” solution so that all your requirements can be purchased from ITALTECNO, from medical and machinery supplies and beyond. We would like to be considered as an extension of the client in terms of the great care and attention, we pay to each specific requirement.
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10

Kimyagaran

Iran
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Kimyagaran

Iran
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Oxycodone Hydrochloride

About the Company : Established in 1995, Kimyagaran Emrooz Chemical Industries Co. is recognized as one of the major leading production enterprises in the ethoxylation and propoxylation industry for m...

Established in 1995, Kimyagaran Emrooz Chemical Industries Co. is recognized as one of the major leading production enterprises in the ethoxylation and propoxylation industry for manufacturing a wide variety of chemicals and pharmaceuticals in the Middle East. The company started out its journey by producing pharmaceutical polyethylene glycols (PEGs). It is currently the leading manufacturer of a wide variety of ethoxylated and propoxylated products that are consumed in 17 different industrial branches. The firm places a lot of emphasis on focuses a lot on research and development. The company currently boasts of over 3,000 customers.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714501800,"product":"OXYCODONE HYDROCHLORIDE BASIC DRUG \/ CONTENT 0.495 KG (*FILE NO: XVI\/4\/28\/N\/OXY\/2024)","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"FSUE MOSCOW ENDOCRINE ","customerCountry":"RUSSIA","quantity":"0.55","actualQuantity":"0.55","unit":"KGS","unitRateFc":"760000","totalValueFC":"5014.7","currency":"INR","unitRateINR":759999.99999999988,"date":"01-May-2024","totalValueINR":"418000","totalValueInUsd":"5014.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9544425","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1672079400,"product":"OXYCODONE HYDROCHLORIDE API-EP-0-0-0","address":"A-43, GROUND FLOOR G.T.KARNAL ROAD INDUSTRIAL AREA,","city":"NEW DELHI","supplier":"WOOD & COMPANY FINANCIAL SERVICES","supplierCountry":"SLOVAKIA","foreign_port":"NA","customer":"VENOR PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.96","actualQuantity":"0.96","unit":"KGS","unitRateFc":"1426","totalValueFC":"1490.1","currency":"EUR","unitRateINR":"127912.2","date":"27-Dec-2022","totalValueINR":"122795.71","totalValueInUsd":"1490.1","indian_port":"DELHI AIR","hs_no":"29391100","bill_no":"3922566","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAK REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"A-43, GROUND FLOOR G.T.KARNAL ROAD INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1672079400,"product":"OXYCODONE HYDROCHLORIDE API-EP-0-0-0","address":"A-43, GROUND FLOOR G.T.KARNAL ROAD INDUSTRIAL AREA,","city":"NEW DELHI","supplier":"WOOD & COMPANY FINANCIAL SERVICES","supplierCountry":"SLOVAKIA","foreign_port":"NA","customer":"VENOR PHARMA LIMITED","customerCountry":"INDIA","quantity":"2.04","actualQuantity":"2.04","unit":"KGS","unitRateFc":"1426","totalValueFC":"3166.5","currency":"EUR","unitRateINR":"127912.2","date":"27-Dec-2022","totalValueINR":"260940.89","totalValueInUsd":"3166.5","indian_port":"DELHI AIR","hs_no":"29391100","bill_no":"3922566","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAK REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"A-43, GROUND FLOOR G.T.KARNAL ROAD INDUSTRIAL AREA,"}]
27-Dec-2022
01-May-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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INTERMEDIATE SUPPLIERS

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01

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

CAS Number : 57664-96-7

End Use API : Oxycodone Hydrochloride

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

02

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

CAS Number : 52446-25-0

End Use API : Oxycodone Hydrochloride

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

03

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

CAS Number : 508-54-3

End Use API : Oxycodone Hydrochloride

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

04

Temad Co

Iran
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Virtual BoothTemad- We think of world-class quality.

CAS Number : 115-37-7

End Use API : Oxycodone Hydrochloride

About The Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class...

Temad

05

Temad Co

Iran
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Virtual BoothTemad- We think of world-class quality.

CAS Number : 467-13-0

End Use API : Oxycodone Hydrochloride

About The Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class...

Temad
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 5MG

USFDA APPLICATION NUMBER - 200534

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DOSAGE - SOLUTION;ORAL - 100MG/5ML

USFDA APPLICATION NUMBER - 200535

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DOSAGE - SOLUTION;ORAL - 5MG/5ML

USFDA APPLICATION NUMBER - 200535

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DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Re...DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 201194

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 202080

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DOSAGE - TABLET;ORAL - 7.5MG

USFDA APPLICATION NUMBER - 202080

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204031

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG

USFDA APPLICATION NUMBER - 208090

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 18M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 18MG

USFDA APPLICATION NUMBER - 208090

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 27M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 27MG

USFDA APPLICATION NUMBER - 208090

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36MG

USFDA APPLICATION NUMBER - 208090

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 9MG

USFDA APPLICATION NUMBER - 208090

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 80MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET;ORAL - 325MG;5MG

USFDA APPLICATION NUMBER - 87003

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Excipients by Applications

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Fillers, Diluents & Binders

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Controlled & Modified Release

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Direct Compression

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SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

02

SPI Pharma

U.S.A
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05

SPI Pharma

U.S.A
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07

SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

10

SPI Pharma

U.S.A
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Thickeners and Stabilizers

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Pfanstiehl

U.S.A
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Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Grade : Parenteral

Category : Parenteral, Thickeners and Stabilizers

04

SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Thickeners and Stabilizers

09

Pfanstiehl

U.S.A
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Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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Taste Masking

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Disintegrants & Superdisintegrants

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

Grade : Oral

Category : Disintegrants & Superdisintegrants

03

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Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

07

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Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

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Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

Brand Name : PolyKoVidone XL

Excipient Details : PolyKoVidone XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

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Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

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Granulation

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DATA COMPILATION #PharmaFlow

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Top drugs and pharmaceutical companies of 2019 by revenues
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

Impressions: 55519

https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020

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Oxycodone HCl

Drug Cost (USD) : 1,805,478

Year : 2022

Prescribers : 413

Prescriptions : 1669

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Oxycodone HCl

Drug Cost (USD) : 178,713,029

Year : 2022

Prescribers : 2109833

Prescriptions : 7760137

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Oxycodone HCl

Drug Cost (USD) : 416,084,689

Year : 2022

Prescribers : 70356

Prescriptions : 581330

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Oxycodone HCl

Drug Cost (USD) : 1,982,538

Year : 2022

Prescribers : 194

Prescriptions : 1630

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Company :

Oxycodone HCl

Drug Cost (USD) : 1,696,033

Year : 2021

Prescribers : 384

Prescriptions : 1668

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Company :

Oxycodone HCl

Drug Cost (USD) : 180,530,233

Year : 2021

Prescribers : 1883940

Prescriptions : 7486820

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Oxycodone HCl

Drug Cost (USD) : 453,164,731

Year : 2021

Prescribers : 84075

Prescriptions : 665848

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Oxycodone HCl

Drug Cost (USD) : 2,508,053

Year : 2021

Prescribers : 251

Prescriptions : 2177

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Company :

Oxycodone HCl

Drug Cost (USD) : 558,686,954

Year : 2020

Prescribers : 101492

Prescriptions : 852784

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Company :

Oxycodone HCl

Drug Cost (USD) : 170,814,813

Year : 2020

Prescribers : 1660084

Prescriptions : 7329109

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Finished Drug Prices

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Brand Name : OXYCODONE HYDROCHLORIDE

India
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RX/OTC/DISCN : DISCN

Oxycodone Hydrochloride

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

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Brand Name : OXYCODONE HYDROCHLORIDE

India
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Oxycodone Hydrochloride

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

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03

Brand Name : OXYCODONE HYDROCHLORIDE

India
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Oxycodone Hydrochloride

Dosage Form : SOLUTION;ORAL

Dosage Strength : 100MG/5ML

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

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Brand Name : OXYCODONE HYDROCHLORIDE

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Oxycodone Hydrochloride

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

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Brand Name : OXYCODONE HYDROCHLORIDE

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Oxycodone Hydrochloride

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

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06

Brand Name : OXYCODONE HYDROCHLORIDE

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Oxycodone Hydrochloride

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Price Per Pack :

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Country : USA

RX/OTC/DISCN : DISCN

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07

Brand Name : OXYCODONE HYDROCHLORIDE

India
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Oxycodone Hydrochloride

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

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08

Brand Name : Oxynorm

Germany
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Brand Name : Oxynorm

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Oxycodone Hydrochloride

Dosage Form : Caps

Dosage Strength : 10mg

Price Per Pack (Euro) : 16.22

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Oxynorm

Germany
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Oxycodone Hydrochloride

Dosage Form : Caps

Dosage Strength : 10mg

Price Per Pack (Euro) : 28.54

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Oxycodone Vita Balance

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Oxycodone Hydrochloride

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 41.855

Published in :

Country : Norway

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ABOUT THIS PAGE

Oxycodone Hydrochloride Manufacturers

A Oxycodone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxycodone Hydrochloride, including repackagers and relabelers. The FDA regulates Oxycodone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxycodone Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Oxycodone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Oxycodone Hydrochloride Suppliers

A Oxycodone Hydrochloride supplier is an individual or a company that provides Oxycodone Hydrochloride active pharmaceutical ingredient (API) or Oxycodone Hydrochloride finished formulations upon request. The Oxycodone Hydrochloride suppliers may include Oxycodone Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Oxycodone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Oxycodone Hydrochloride USDMF

A Oxycodone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxycodone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Oxycodone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Oxycodone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Oxycodone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxycodone Hydrochloride USDMF includes data on Oxycodone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxycodone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Oxycodone Hydrochloride suppliers with USDMF on PharmaCompass.

Oxycodone Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Oxycodone Hydrochloride Drug Master File in Japan (Oxycodone Hydrochloride JDMF) empowers Oxycodone Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Oxycodone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxycodone Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Oxycodone Hydrochloride suppliers with JDMF on PharmaCompass.

Oxycodone Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Oxycodone Hydrochloride Drug Master File in Korea (Oxycodone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxycodone Hydrochloride. The MFDS reviews the Oxycodone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Oxycodone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Oxycodone Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Oxycodone Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Oxycodone Hydrochloride suppliers with KDMF on PharmaCompass.

Oxycodone Hydrochloride CEP

A Oxycodone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxycodone Hydrochloride Certificate of Suitability (COS). The purpose of a Oxycodone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxycodone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxycodone Hydrochloride to their clients by showing that a Oxycodone Hydrochloride CEP has been issued for it. The manufacturer submits a Oxycodone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxycodone Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxycodone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxycodone Hydrochloride DMF.

A Oxycodone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxycodone Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Oxycodone Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Oxycodone Hydrochloride WC

A Oxycodone Hydrochloride written confirmation (Oxycodone Hydrochloride WC) is an official document issued by a regulatory agency to a Oxycodone Hydrochloride manufacturer, verifying that the manufacturing facility of a Oxycodone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxycodone Hydrochloride APIs or Oxycodone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxycodone Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Oxycodone Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Oxycodone Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Oxycodone Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Oxycodone Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Oxycodone Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Oxycodone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxycodone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Oxycodone Hydrochloride suppliers with NDC on PharmaCompass.

Oxycodone Hydrochloride GMP

Oxycodone Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Oxycodone Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Oxycodone Hydrochloride GMP manufacturer or Oxycodone Hydrochloride GMP API supplier for your needs.

Oxycodone Hydrochloride CoA

A Oxycodone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Oxycodone Hydrochloride's compliance with Oxycodone Hydrochloride specifications and serves as a tool for batch-level quality control.

Oxycodone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxycodone Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Oxycodone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxycodone Hydrochloride EP), Oxycodone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxycodone Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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