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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 5 USDMF, 3 CEP/COS, 7 EU WC, 2 KDMF, 5 NDC API, 22 Listed Suppliers, $ API Reference Price

28 API Suppliers
5 USDMF
3 CEP/COS
7 EU WC
2 KDMF
5 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 30 FDA Orange Book, 115 Europe, 8 Canada, 5 Australia, 5 South Africa, 53 Listed Dossiers

216 FDF Dossiers
30 FDA Orange Book
115 Europe
8 Canada
5 Australia
5 South Africa
53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 31 Controlled & Modified Release, 25 Direct Compression, 18 Disintegrants & Superdisintegrants, 18 Granulation, 17 Thickeners and Stabilizers, 14 Solubilizers, 12 Lubricants & Glidants, 12 Co-Processed Excipients, 11 Topical, 10 Film Formers & Plasticizers, 7 Parenteral, 6 Taste Masking, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

30 NEWS #PharmaBuzz

media
30 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 93 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
93 Finished Drug Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

marketPlace
26 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

53 US Patents, 8 US Exclusivities, 56 Health Canada Patents

patents
53 US Patents
8 US Exclusivities
56 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 526

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

216

FDF Dossiers

FDA Orange Book

115

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

123,879,054

Annual Reports (USD Million)

Finished Drug Prices

193 RELATED EXCIPIENT COMPANIES

312EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as: 175591-09-0, Tapentadol hcl, Nucynta, Palexia, Tapentadol (hydrochloride), Nucynta er

Molecular Formula

C₁₄H₂₄ClNO

Molecular Weight

257.80 g/mol

InChI Key

ZELFLGGRLLOERW-YECZQDJWSA-N

FDA UNII

71204KII53

An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.

1 2D Structure

Tapentadol

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride

2.1.2 InChI

InChI=1S/C14H23NO.ClH/c1-5-14(11(2)10-15(3)4)12-7-6-8-13(16)9-12;/h6-9,11,14,16H,5,10H2,1-4H3;1H/t11-,14+;/m0./s1

2.1.3 InChI Key

ZELFLGGRLLOERW-YECZQDJWSA-N

2.1.4 Canonical SMILES

CCC(C1=CC(=CC=C1)O)C(C)CN(C)C.Cl

2.1.5 Isomeric SMILES

CC[C@@H](C1=CC(=CC=C1)O)[C@@H](C)CN(C)C.Cl

2.2 Other Identifiers

2.2.1 UNII

71204KII53

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol

2. Nucynta

3. Tapentadol

2.3.2 Depositor-Supplied Synonyms

1. 175591-09-0

2. Tapentadol Hcl

3. Nucynta

4. Palexia

5. Tapentadol (hydrochloride)

6. Nucynta Er

7. Bn-200 Hydrochloride

8. Cg5503 Hydrochloride

9. Cg-5503 Hydrochloride

10. 3-((2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl)phenol Hydrochloride

11. 71204kii53

12. 175591-09-0 (hcl)

13. Tapentadol Hydrochloride (jan)

14. Tapentadol Hydrochloride [jan]

15. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride

16. Palexia Retard

17. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol Hydrochloride

18. Unii-71204kii53

19. Palexia Sr

20. Phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, Hydrochloride (1:1)

21. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride (1:1)

22. Nucynta (tn)

23. Schembl238138

24. Jns-024 Er

25. Chembl1201777

26. Dtxsid00938677

27. Amy25232

28. Hy-70042a

29. Mfcd00944992

30. Tapentadol Hydrochloride [mi]

31. Akos016842888

32. Cs-0879

33. Tapentadol Hydrochloride [mart.]

34. Tapentadol Hydrochloride [vandf]

35. Tapentadol Hydrochloride [who-dd]

36. Ac-32018

37. Tapentadol Hydrochloride [orange Book]

38. D10199

39. Tapentadol Hydrochloride [ep Monograph]

40. 591t238

41. Tapentadol Hydrochloride (1.0 Mg/ml In Methanol)

42. R-331333

43. Q27265914

44. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl) Phenol Hydrochloride

45. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol Hydrochloride

46. 3-[(2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride

47. 3-[1-(dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen Chloride (1/1)

48. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol Hydrochloride

49. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol Hydrochloride

50. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Monohydrochloride

51. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride

52. Phenol, 3-(3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride, (r-(r*,r*))-

53. Tapentadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₂₄ClNO
Molecular Weight	257.80 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	5
Exact Mass	257.1546421 g/mol
Monoisotopic Mass	257.1546421 g/mol
Topological Polar Surface Area	23.5 Å²
Heavy Atom Count	17
Formal Charge	0
Complexity	193
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Nucynta
PubMed Health	Tapentadol (By mouth)
Drug Classes	Analgesic
Drug Label	NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
Active Ingredient	Tapentadol hydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml
Market Status	Prescription
Company	Janssen Pharms

2 of 4
Drug Name	Nucynta er
Drug Label	NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
Active Ingredient	Tapentadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base
Market Status	Prescription
Company	Janssen Pharms

3 of 4
Drug Name	Nucynta
PubMed Health	Tapentadol (By mouth)
Drug Classes	Analgesic
Drug Label	NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
Active Ingredient	Tapentadol hydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml
Market Status	Prescription
Company	Janssen Pharms

4 of 4
Drug Name	Nucynta er
Drug Label	NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
Active Ingredient	Tapentadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base
Market Status	Prescription
Company	Janssen Pharms

4.2 Drug Indication

Treatment of acute pain

Treatment of chronic pain

Treatment of acute pain

Treatment of chronic pain

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic Uptake Inhibitors

Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonists [MoA]; Opioid Agonist [EPC]

API SUPPLIERS

01

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Attending

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

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Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Virupaksha Organics

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Booth #RH.D18

With Virupaksha, you get a quality product with on-time delivery.

Contact Supplier

India

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Digital Content

USDMF CEP/COS JDMF EU-WC

NDC KDMF VMF EU

AUDIT

03

Ami Lifesciences Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

Contact Supplier

India

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Digital Content

USDMF CEP/COS

JDMF EU-WC

NDC KDMF VMF Others AUDIT

04

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Booth #2.D38

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU

AUDIT

05

Noramco

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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U.S.A

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Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

06

Farmhispania

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

Contact Supplier

Spain

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Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Corporate PDF

07

Curia

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

08

Alkem Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

09

Alkem Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

10

American Pacific Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

SupplySide West 2024

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Noramco Llc

U.S.A

Saudi International Expo

Not Confirmed

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Contact Supplier

U.S.A

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Digital Content

Tapentadol Hydrochloride (r331333) Drug Substa...

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-05

Pay. Date : 2020-07-30

DMF Number : 21084

Submission : 2008-01-23

Status : Active

Type : II

02

Alkem Laboratories Ltd

India

Saudi International Expo

Not Confirmed

03

Alkem Laboratories Ltd

India

Saudi International Expo

Not Confirmed

04

Ampac Fine Chemicals Llc

U.S.A

Saudi International Expo

Not Confirmed

05

Curia Missouri Inc

U.S.A

Saudi International Expo

Not Confirmed

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CEP/COS

01

AMI LIFESCIENCES PRIVATE LIMITED Ka...

India

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

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India

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Digital Content

Tapentadol hydrochloride

Certificate Number : R0-CEP 2021-290 - Rev 00

Status : Valid

Issue Date : 2022-11-24

Type : Chemical

Substance Number : 3035

02

Grunenthal GmbH Aachen DE

Germany

SupplySide West 2024

Not Confirmed

03

SYMED LABS LIMITED Hyderabad IN

India

SupplySide West 2024

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

01

Cohance Lifesciences

India

CPhI India 2024

Attending

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

(2S, 3R)-1-(Dimethylamino)-3-(3-methoxyphenyl)-2-m...

CAS Number : 809282-20-0

End Use API : Tapentadol

02

Cohance Lifesciences

India

CPhI India 2024

Attending

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

3-Methoxy propiophenone

CAS Number : 37951-49-8

End Use API : Tapentadol

03

SANIKA CHEMICALS PVT. LTD

India

2024 ACI Convention

Not Confirmed

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 200533

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 200533

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

USFDA APPLICATION NUMBER - 200533

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE

USFDA APPLICATION NUMBER - 200533

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 200533

DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 203794

DOSAGE - TABLET;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 22304

DOSAGE - TABLET;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 22304

DOSAGE - TABLET;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 22304

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

28 API Suppliers

5 USDMF

3 CEP/COS

7 EU WC

2 KDMF

5 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers

30 FDA Orange Book

115 Europe

8 Canada

5 Australia

5 South Africa

53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 75MG BASE

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6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

19 BASF

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2 The Dow Chemical Company

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EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders

51 Coating Systems & Additives

SOLUTION;ORAL - EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons