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ACTIVE PHARMA INGREDIENTS

56 API Suppliers, 25 USDMF, 3 JDMF, 20 EU WC, 11 KDMF, 19 NDC API, 43 Listed Suppliers, $ API Reference Price

56 API Suppliers
25 USDMF
3 JDMF
20 EU WC
11 KDMF
19 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 52 FDA Orange Book, 70 Europe, 34 Canada, 30 Australia, 2 South Africa, 31 Listed Dossiers

219 FDF Dossiers
52 FDA Orange Book
70 Europe
34 Canada
30 Australia
2 South Africa
31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 30MG BASE, TABLET;ORAL - EQ 60MG BASE, TABLET;ORAL - EQ 90MG BASE

drugProductComposition
TABLET;ORAL - EQ 30MG BASE
TABLET;ORAL - EQ 60MG BASE
TABLET;ORAL - EQ 90MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 DFE Pharma, 6 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 5 Kerry, 9 Microlex e.U, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 13 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 2 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Fillers, Diluents & Binders, 30 Direct Compression, 22 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 15 Granulation, 13 Co-Processed Excipients, 11 Lubricants & Glidants, 9 Solubilizers, 8 Controlled & Modified Release, 8 Chewable & Orodispersible Aids, 5 Taste Masking, 4 Coating Systems & Additives, 3 Emulsifying Agents, 2 Parenteral, 2 Film Formers & Plasticizers, 1 API Stability Enhancers, 1 Rheology Modifiers

excipientsByApplications
42 Fillers, Diluents & Binders
30 Direct Compression
22 Disintegrants & Superdisintegrants
15 Thickeners and Stabilizers
15 Granulation
13 Co-Processed Excipients
11 Lubricants & Glidants
9 Solubilizers
8 Controlled & Modified Release
8 Chewable & Orodispersible Aids
5 Taste Masking
4 Coating Systems & Additives
3 Emulsifying Agents
2 Parenteral
2 Film Formers & Plasticizers
1 API Stability Enhancers
1 Rheology Modifiers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 38 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices, 16 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
46 Finished Drug Prices
16 Annual Reports

MARKET PLACE

5 APIs, 3 FDF Dossiers

marketPlace
5 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 9 Health Canada Patents

patents
6 US Patents
9 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP , 32 Others

otherSolutions
3 USP
32 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 2,054

MARKET PLACE

API

FDF

14INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

219

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

124,494,842

Annual Reports (USD Million)

7,966

Finished Drug Prices

105 RELATED EXCIPIENT COMPANIES

191EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 364782-34-3, Cinacalcet hcl, Sensipar, Mimpara, Amg073 hcl, Regpara

Molecular Formula

C₂₂H₂₃ClF₃N

Molecular Weight

393.9 g/mol

InChI Key

QANQWUQOEJZMLL-PKLMIRHRSA-N

FDA UNII

1K860WSG25

Cinacalcet Hydrochloride is the orally bioavailable hydrochloride salt of the calcimimetic cinacalcet. Cinacalcet increases the sensitivity of calcium-sensing receptors on chief cells in the parathyroid gland to extracellular calcium, thereby reducing parathyroid hormone (PTH) secretion. A reduction in PTH levels inhibits osteoclast activity, which may result in a decrease in cortical bone turnover and bone fibrosis, and normalization of serum calcium and phosphorus levels. In addition, by reducing PTH levels, cinacalcet may reduce PSA levels; PTH appears to raise PSA levels and may increase prostate cancer cell growth.

1 2D Structure

Cinacalcet Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[(1R)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C22H22F3N.ClH/c1-16(20-13-5-10-18-9-2-3-12-21(18)20)26-14-6-8-17-7-4-11-19(15-17)22(23,24)25;/h2-5,7,9-13,15-16,26H,6,8,14H2,1H3;1H/t16-;/m1./s1

2.1.3 InChI Key

QANQWUQOEJZMLL-PKLMIRHRSA-N

2.1.4 Canonical SMILES

CC(C1=CC=CC2=CC=CC=C21)NCCCC3=CC(=CC=C3)C(F)(F)F.Cl

2.1.5 Isomeric SMILES

C[C@H](C1=CC=CC2=CC=CC=C21)NCCCC3=CC(=CC=C3)C(F)(F)F.Cl

2.2 Other Identifiers

2.2.1 UNII

1K860WSG25

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Alpha-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-1-naphthalenemethanamine, (alphar)-hydrochloride

2. Amg 073

3. Amg073

4. Cinacalcet

5. Krn 1493

6. Sensipar

2.3.2 Depositor-Supplied Synonyms

1. 364782-34-3

2. Cinacalcet Hcl

3. Sensipar

4. Mimpara

5. Amg073 Hcl

6. Regpara

7. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hydrochloride

8. Cinacalcet, Hcl

9. Cinacalcet Hydrochloride [usan]

10. Cinacalcet (hydrochloride)

11. Amg-073 Hcl

12. Amg073 Hydrochloride

13. Chebi:48391

14. 1k860wsg25

15. Parareg

16. N-[(1r)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine;hydrochloride

17. Amg-073 Hcl (cinacalcet Hydrochloride)

18. 364782-34-3 (hcl)

19. [(1r)-1-(naphthalen-1-yl)ethyl]({3-[3-(trifluoromethyl)phenyl]propyl})amine Hydrochloride

20. Dsstox_cid_26792

21. Dsstox_rid_81909

22. N-((1r)-1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hydrochloride

23. N-[(1r)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine Hydrochloride

24. Dsstox_gsid_46792

25. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoro-methyl)phenyl)propan-1-amine Hydrochloride

26. Smr002530058

27. Cas-364782-34-3

28. Krn 1493

29. Ncgc00181002-01

30. Amg 073 Hcl

31. Unii-1k860wsg25

32. Sensipar (tn)

33. Mimpara (tn)

34. Cnc-hcl

35. Cinacelcet Hydrochloride

36. Sensipar(tm)

37. Amg-073 Hydrochloride

38. Amg-073.hcl

39. Mls004774045

40. Mls006010213

41. Chembl1200776

42. Dtxsid3046792

43. Bcpp000409

44. Bcp02533

45. Nps-1493

46. Tox21_112654

47. Cinacalcet Hydrochloride (jan/usan)

48. Cinacalcet Hydrochloride [mi]

49. Hy-70037a

50. Mfcd08067750

51. S1260

52. Cinacalcet Hydrochloride [jan]

53. Akos005146514

54. Akos015969126

55. Tox21_112654_1

56. Ac-1799

57. Am90312

58. Bcp9000286

59. Ccg-268579

60. Cs-0288

61. Gs-4171

62. Cinacalcet Hydrochloride [mart.]

63. Cinacalcet Hydrochloride [usp-rs]

64. Cinacalcet Hydrochloride [who-dd]

65. Ncgc00181002-04

66. 1-naphthalenemethanamine, Alpha-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-, (alphar)-, Hydrochloride

67. Sw219246-1

68. Cinacalcet Hydrochloride [orange Book]

69. D03505

70. 782c343

71. J-520045

72. Q27121179

73. Z1741977003

74. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hcl

75. (r)-n-(3-(3-(trifluoromethyl)phenyl)propyl)-1- -(1-napthyl)ethylamine Hydrochloride

76. (alphar)-alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl)propyl]-1-napthalenemethanamine Hydrochloride

77. 1-naphthalenemethanamine, .alpha.-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-, (.alpha.r)-, Hydrochloride

78. 1-naphthalenemethanamine, Alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-, Hydrochloride (1:1), (alphar)-

79. 1-naphthalenemethanamine,a-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-, Hydrochloride, (ar)-

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₃ClF₃N
Molecular Weight	393.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	6
Exact Mass	393.1471119 g/mol
Monoisotopic Mass	393.1471119 g/mol
Topological Polar Surface Area	12 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	422
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
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	Cinacalcet hydrochloride
PubMed Health	Cinacalcet (By mouth)
Drug Classes	Calcium Regulator
Drug Label	Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt...
Active Ingredient	Cinacalcet hydrochloride
Dosage Form	Tablet
Route	oral
Strength	60mg; 30mg; 90mg
Market Status	Tentative Approval
Company	Teva Pharms; Barr

2 of 4
Drug Name	Sensipar
Drug Label	Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt...
Active Ingredient	Cinacalcet hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 90mg base; eq 30mg base; eq 60mg base
Market Status	Prescription
Company	Amgen

3 of 4
Drug Name	Cinacalcet hydrochloride
PubMed Health	Cinacalcet (By mouth)
Drug Classes	Calcium Regulator
Drug Label	Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt...
Active Ingredient	Cinacalcet hydrochloride
Dosage Form	Tablet
Route	oral
Strength	60mg; 30mg; 90mg
Market Status	Tentative Approval
Company	Teva Pharms; Barr

4 of 4
Drug Name	Sensipar
Drug Label	Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt...
Active Ingredient	Cinacalcet hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 90mg base; eq 30mg base; eq 60mg base
Market Status	Prescription
Company	Amgen

4.2 Drug Indication

* Secondary hyperparathyroidism :

Adults

Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Paediatric population

Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4. 4).

Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5. 1).

* Parathyroid carcinoma and primary hyperparathyroidism in adults:

Reduction of hypercalcaemia in adult patients with:

- parathyroid carcinoma.

- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.

Reduction of hypercalcaemia in patients with:

- parathyroid carcinoma

- primary HPT for whom parathyroidectomy

would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

* Secondary hyperparathyroidism :

Adults

Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy.

Paediatric population

Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.

Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate.

Parathyroid carcinoma and primary hyperparathyroidism in adults.

Reduction of hypercalcaemia in adult patients with:

- parathyroid carcinoma;

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5. 1).

Reduction of hypercalcaemia in patients with:

-parathyroid carcinoma.

- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium

levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Treatment of parathyroid carcinoma, Treatment of primary hyperparathyroidism , Treatment of secondary hyperparathyroidism in patients with end-stage renal disease

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Calcimimetic Agents

Small organic molecules that act as allosteric activators of the calcium sensing receptor (CaSR) in the PARATHYROID GLANDS and other tissues. They lower the threshold for CaSR activation by extracellular calcium ions and diminish PARATHYROID HORMONE (PTH) release from parathyroid cells. (See all compounds classified as Calcimimetic Agents.)

Calcium-Regulating Hormones and Agents

Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Increased Calcium-sensing Receptor Sensitivity [MoA]; Calcium-sensing Receptor Agonist [EPC]

5.3 ATC Code

H05BX01

API SUPPLIERS

01

Dr. Reddy\'s Laboratories

India

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

CPhI Worldwide, Milan

Booth #24A41

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

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India

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NDC

KDMF VMF EU, CA, ...

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02

ASolution Pharmaceuticals

India

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

CPhI Worldwide, Milan

Attending

ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.

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India

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03

Aarti Pharmalabs

India

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

CPhI Worldwide, Milan

Booth #3F17

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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NDC KDMF VMF ASMF

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04

HRV Global Life Sciences

India

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

CPhI Worldwide, Milan

Booth #3A25

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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05

Medichem S.A

Spain

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

CPhI Worldwide, Milan

Booth #10F42

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

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USDMF

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06

Megafine Pharma (P) Limited

India

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

CPhI Worldwide, Milan

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USDMF

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AUDIT

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07

Bal Pharma

India

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

CPhI Worldwide, Milan

Booth #2D82

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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08

UQUIFA

Spain

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ASC 2024

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09

Solara Active Pharma Sciences

India

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

ASC 2024

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10

Piramal Pharma Solutions

U.S.A

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USDMF

01

Dr Reddys Laboratories Ltd

India

CPhI Worldwide, Milan

Booth #24A41

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

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India

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Cinacalcet Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-22

Pay. Date : 2013-07-03

DMF Number : 27211

Submission : 2013-06-28

Status : Active

Type : II

02

Medichem Manufacturing Malta Ltd

Spain

CPhI Worldwide, Milan

Booth #10F42

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

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Cinacalcet Hydrochloride (med-200140/m )

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-25

Pay. Date : 2014-03-14

DMF Number : 21405

Submission : 2008-03-06

Status : Active

Type : II

03

Megafine Pharma P Ltd

India

CPhI Worldwide, Milan

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Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

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Cinacalcet Hydrochloride (non-sterile Drug Sub...

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DMF Review : Complete

Rev. Date : 2013-02-23

Pay. Date : 2012-12-24

DMF Number : 24881

Submission : 2011-04-22

Status : Active

Type : II

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Sun Pharmaceutical Industries Ltd

India

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JDMF

01

HETERO DRUGS LIMITED.

India

Gabon

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EU WC

01

Dr. Reddy\'s Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

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Cinacalcet Hydrochloride IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

02

Aarti Pharmalabs

India

CPhI Worldwide, Milan

Booth #3F17

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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India

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Cinacalcet Hydrochloride IH

Date of Issue : 2023-01-06

Valid Till : 2025-07-29

Written Confirmation Number : WC-0099

Address of the Firm : Plot No. E-50, Unit-IV, MIDC, Tarapur - 401506, Taluka: Palghar, District: Thane...

03

Megafine Pharma (P) Limited

India

CPhI Worldwide, Milan

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Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

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Cinacalcet Hydrochloride IH

Date of Issue : 2022-07-27

Valid Till : 2025-07-21

Written Confirmation Number : WC-0087-(Annexure-1)

Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Village Lakhmapur, Taluka Dindo...

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04

Aurobindo Pharma Limited

India

ASC 2024

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05

Cipla

India

ASC 2024

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06

Dishman Carbogen Amcis

India

ASC 2024

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07

10

Mehta API

India

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Listed Suppliers

01

Dr. Reddy\'s Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

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India

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Cinacalcet Hydrochloride

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

02

ASolution Pharmaceuticals

India

CPhI Worldwide, Milan

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Cinacalcet Hydrochloride

About the Company : Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality,...

Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality, embedding our values into every endeavor. Our aim is to cultivate mutually beneficial relationships with customers, suppliers, and ourselves, fostering sustainable growth. Empowered by visionary leadership and a quality-driven team, ASolution is steadfast in providing innovative solutions to challenges such as Process Development, Optimization, Drug Product and Substance Manufacturing, and more.

03

Aarti Pharmalabs

India

CPhI Worldwide, Milan

Booth #3F17

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

Contact Supplier

India

Virtual Booth

Digital Content

Cinacalcet

About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...

Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It also offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

04

HRV Global Life Sciences

India

CPhI Worldwide, Milan

Booth #3A25

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

Cinacalcet Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

05

Medichem S.A

Spain

CPhI Worldwide, Milan

Booth #10F42

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Contact Supplier

Spain

Virtual Booth

Digital Content

Cinacalcet Hydrochloride

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

06

Megafine Pharma (P) Limited

India

CPhI Worldwide, Milan

Attending

Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

Contact Supplier

India

Virtual Booth

Digital Content

Cinacalcet Hydrochloride

About the Company : Megafine, established in 1995, is a privately owned and professionally managed enterprise with its corporate office in MUMBAI and two multipurpose manufacturing sites at VAPI & NAS...

Megafine, established in 1995, is a privately owned and professionally managed enterprise with its corporate office in MUMBAI and two multipurpose manufacturing sites at VAPI & NASHIK in India for APIs & Intermediates. The facilities have been successfully inspected by US-FDA, EDQM, Japan PMDA, Health Canada, TGA Australia, ANVISA Brazil, COFEPRIS Mexico, Korea MFDS & WHO besides being certified for ISO 9001:2008, 14001:2004 & OHSAS 18001:2007. The company focuses on niche molecules for the regulated market globally.

Corporate PDF

07

Bal Pharma

India

CPhI Worldwide, Milan

Booth #2D82

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Cinacalcet Hydrochloride

About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...

Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk actives. We are dedicated to enhancing patients' quality of life by offering products that are safe, effective, high-quality, and affordable. Bal Pharma's APIs and FDFs are produced at world-class manufacturing facilities. Our APIs are widely exported to Europe, the Far East, Latin America, Africa, the Middle East, and other global markets. Our FDFs are exported to semi-regulated and non-regulated markets, and we are now entering regulated markets.

08

Ningbo Zhenlei Chemical Co.,Ltd

China

ASC 2024

Not Confirmed

09

Rampex Labs

India

ASC 2024

Not Confirmed

10

Solara Active Pharma Sciences

India

ASC 2024

Not Confirmed

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

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API Reference Price

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,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"ACTIVE PHARMACEUTICAL INGREDIENTS - OTHER ORGANIC CHEMICAL COMPOUNDS CINACALCET HYDROCHLORIDE","address":"SETHNA BUILDING, 4TH FLR,","city":"LINES, MUMBAI ,MAHARASHTRA","supplier":"MEGAFINE PHARMA (P) LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"T.C ZIRAAT BANKASI A.S","customerCountry":"TURKEY","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"2300","totalValueFC":"11331.4","currency":"USD","unitRateINR":190092.79999999999,"date":"23-Aug-2024","totalValueINR":"950464","totalValueInUsd":"11331.4","indian_port":"Bombay Air","hs_no":"29214990","bill_no":"3441067","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SETHNA BUILDING, 4TH FLR,, LINES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"CINACALCET HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1621621800,"product":"CINACALCET HYDROCHLORIDE - CINACALCET HYDROCHLORIDE (EU)","address":"T-184, MIDC, BHOSARI,PUNE","city":"PUNE-MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"2100","totalValueFC":"169951","currency":"USD","unitRateINR":"155610","date":"22-May-2021","totalValueINR":"12448800","totalValueInUsd":"169951","indian_port":"BOMBAY AIR","hs_no":"29214990","bill_no":"4041966","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"","customerAddress":"T-184, MIDC, BHOSARI,PUNE"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635877800,"product":"(FOC) CINACALCET HCI LOT NO:F-210034 (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU","city":"BANGALORE,KARNATAKA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"218.09","actualQuantity":"218.09","unit":"KGS","unitRateFc":"2524.8","totalValueFC":"560467.8","currency":"USD","unitRateINR":"191383.1","date":"03-Nov-2021","totalValueINR":"41738739.4","totalValueInUsd":"560467.8","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"6114800","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"CINACALCET HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA","city":"MUMBAI,MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"11.01","actualQuantity":"11.01","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"23244.3","currency":"USD","unitRateINR":"167982.2","date":"05-Aug-2022","totalValueINR":"1849483.73","totalValueInUsd":"23244.3","indian_port":"DELHI AIR","hs_no":"29214290","bill_no":"9872428","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"CINACALCET HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA","city":"MUMBAI,MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"56.78","actualQuantity":"56.78","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"119873.9","currency":"USD","unitRateINR":"167982.1","date":"05-Aug-2022","totalValueINR":"9538025.76","totalValueInUsd":"119873.9","indian_port":"DELHI AIR","hs_no":"29214290","bill_no":"9872428","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663525800,"product":"CINACALCET HCL (CINACALCET HYDROCHLORIDE )","address":"T-184, MIDC, BHOSARI,,PUNE","city":"PUNE,MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"2100","totalValueFC":"63203.6","currency":"USD","unitRateINR":"168840","date":"19-Sep-2022","totalValueINR":"5065200","totalValueInUsd":"63203.6","indian_port":"BOMBAY AIR","hs_no":"29214990","bill_no":"2509287","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"T-184, MIDC, BHOSARI,,PUNE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1664994600,"product":"CINACALCET HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA","city":"MUMBAI,MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"49.50","actualQuantity":"49.5","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"101206.9","currency":"USD","unitRateINR":"168237","date":"06-Oct-2022","totalValueINR":"8327731.5","totalValueInUsd":"101206.9","indian_port":"DELHI AIR","hs_no":"29214290","bill_no":"2755186","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685039400,"product":"CINACALCET HYDROCHLORIDE FOC SAMPLE NOT FOR SALE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO MATULYA CENTRE, SENAPATI BAPAT MARG","city":"MUMBAI","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"0.28","actualQuantity":"0.275","unit":"KGS","unitRateFc":"2094.5","totalValueFC":"583.1","currency":"USD","unitRateINR":"174475.6","date":"26-May-2023","totalValueINR":"47980.8","totalValueInUsd":"583.1","indian_port":"DELHI AIR","hs_no":"29214290","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Spain","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO MATULYA CENTRE, SENAPATI BAPAT MARG"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701887400,"product":"CINACALCET HCL","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1600","totalValueFC":"32329.4","currency":"USD","unitRateINR":"134560","date":"07-Dec-2023","totalValueINR":"2691200","totalValueInUsd":"32329.4","indian_port":"Delhi Air","hs_no":"29214290","bill_no":"9111098","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701887400,"product":"CINACALCET HCL","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"20.07","actualQuantity":"20.07","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"42428.8","currency":"USD","unitRateINR":"175979.3","date":"07-Dec-2023","totalValueINR":"3531903.55","totalValueInUsd":"42428.8","indian_port":"Delhi Air","hs_no":"29214290","bill_no":"9112485","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701887400,"product":"CINACALCET HCL","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"29.35","actualQuantity":"29.35","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"62047","currency":"USD","unitRateINR":"175979.3","date":"07-Dec-2023","totalValueINR":"5164990.99","totalValueInUsd":"62047","indian_port":"Delhi Air","hs_no":"29214290","bill_no":"9112485","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"CINACALCET HYDROCHLORIDE(QTY:1 X 250 MG, VALUE: USD422) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"1688000","totalValueFC":"444.3","currency":"USD","unitRateINR":"148343960","date":"26-Jun-2024","totalValueINR":"37085.99","totalValueInUsd":"444.3","indian_port":"Hyderabad Air","hs_no":"29214990","bill_no":"4196499","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]

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

01 Dr. Reddy\'s Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Lead Product(s) : Cinacalcet Hydrochloride

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

DEALS_DEV

Dr. Reddy's Laboratories Announces the Launch of Cinacalcet Tablets in the U.S. Market

Details : Cinacalcet Tablets is a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 01, 2020

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Virtual Booth

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INTERMEDIATES SUPPLIERS

01

Minakem

France

CPhI Worldwide, Milan

Booth #5A73

Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

(R )-(+)-1-(1-Naphtyl)-ethylamine Hydrochloride

CAS Number : 82572-04-1

End Use API : Cinacalcet Hydrochloride

Product Web Link

02

DKSH

Switzerland

CPhI Worldwide, Milan

Booth #6C42

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

1 ACETYL NAPHTHALENE (1 ACETONAPHTHONE)

CAS Number : 941-98-0

End Use API : Cinacalcet Hydrochloride

03

Malladi Drugs & Pharmaceuticals Lim...

India

CPhI Worldwide, Milan

Booth #3B11

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

R-Naphthylethyl amine

CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

Portfolio PDF

Product Web Link

Virtual Booth

China

ASC 2024

Not Confirmed

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

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FDF Dossiers

01

Cohance Lifesciences

India

CPhI Worldwide, Milan

Booth #4B1

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Cohance Lifesciences

India

CPhI Worldwide, Milan

Booth #4B1

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Cohance Lifesciences

India

CPhI Worldwide, Milan

Booth #4B1

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 90MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

04

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

05

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

06

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

07

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

08

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 60 mg

Packaging : 28 UNITS 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

09

Dr. Reddy's Laboratories

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 90 mg

Packaging : 28 UNITS 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

10

Strides Pharma Science

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2018-04-30

Application Number : 209226

Regulatory Info : RX

Registration Country : USA

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

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FDA Orange Book

01

DR REDDYS

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

02

DR REDDYS

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

03

DR REDDYS

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

04

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

05

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

06

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

07

ACCORD HLTHCARE

United Kingdom

ASC 2024

Not Confirmed

08

WATSON LABS TEVA

Ireland

ASC 2024

Not Confirmed

09

BARR

U.S.A

ASC 2024

Not Confirmed

10

CIPLA

India

ASC 2024

Not Confirmed

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

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Europe

01

DR. REDDY'S SRL

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

02

DR. REDDY'S SRL

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 60 mg

Packaging : 28 UNITS 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

03

DR. REDDY'S SRL

India

CPhI Worldwide, Milan

Booth #24A41

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 90 mg

Packaging : 28 UNITS 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

04

Accord Healthcare Ltd.

United Kingdom

ASC 2024

Not Confirmed

05

Amgen Europe B.V.

U.S.A

ASC 2024

Not Confirmed

06

09

Devatis AG

Switzerland

ASC 2024

Not Confirmed

10

Mylan S.A.S.

U.S.A

ASC 2024

Not Confirmed

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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;ORAL - EQ 30MG BASE

USFDA APPLICATION NUMBER - 21688

DOSAGE - TABLET;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 21688

DOSAGE - TABLET;ORAL - EQ 90MG BASE

USFDA APPLICATION NUMBER - 21688

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Direct Compression

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Granulation

Co-Processed Excipients

Lubricants & Glidants

Solubilizers

Controlled & Modified Release

Chewable & Orodispersible Aids

Taste Masking

01

SPI Pharma

U.S.A

CPhI Worldwide, Milan

Booth #6G33

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : Advantose FS95

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Fructose

02

SPI Pharma

U.S.A

CPhI Worldwide, Milan

Booth #6G33

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : MS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-170, Taped Density: 0.80

Ingredient(s) : Starch

03

SPI Pharma

U.S.A

CPhI Worldwide, Milan

Booth #6G33

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : CS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-175, Tapped Density: 0.85

Ingredient(s) : Calcium Carbonate Excipient

04

Sigachi Industries

India

FNCE 2024

Not Confirmed

05

Gangwal Chemicals

India

FNCE 2024

Not Confirmed

Coating Systems & Additives

Emulsifying Agents

Parenteral

Film Formers & Plasticizers

API Stability Enhancers

Rheology Modifiers

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DATA COMPILATION #PharmaFlow

NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Annual Reports

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Market Place

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APIs

Various APIs needed in Jordan [ENA07802]

A pharmaceutical company based in Jordan that develops, manufactures, markets and distributes branded generic pharmaceuticals and under-licensed products globally, with a strong focus on the Middle East and North Africa region is looking for suppliers of Various APIs. The suppliers must support this enquiry with GMP, USDMF & CoA. 1. Ph. Eur Grade Tamsulosin HCl (10 kg) 2. Cinacalcet Hydrochloride (70 kg) 3. Injectable Grade Vancomycin Hydrochloride (100 kg) 4. Injectable Grade Iohexol (60 kg) 5. Injectable Grade, USP Grade Acetaminophen (250 kg)

06 Jul 2020

Cinacalcet Hydrochloride API needed in the US [ENA07376]

A complete drug product development company is looking for suppliers of Cinacalcet Hydrochloride API. The suppliers must support this enquiry with an active USDMF.

22 May 2020

Spironolactone & Cinacalcet HCl APIs needed in India [ENA06081]

A vertically integrated pharmaceutical company with 15 years, of experience, having established state-of-the-art manufacturing facilities in API, Formulations and Clinical Research is looking for suppliers of Spironolactone & Cinacalcet HCl APIs. The suppliers must support this enqury with Brazilian and GCC countries documentation.

17 Dec 2019

Propofol, Piribedil and other APIs needed in Russia [ENA05300]

A Russian pharmaceutical company specializing in the wholesale supply of immunobiological drugs and diagnostic products is looking for suppliers of APIs mentioned below. 1. Propofol 2. Piribedil 3. Cinacalcet 4. Diatrizoate Sodium.

28 Sep 2019

Enquiry// Valsartan, Hydrochlorothiazide, Zolpidem Tartrate and other APIs are needed in India [ENA01374]

Celogen generics brings to global market Quality Generics, which are equivalent to the original molecule. Celogen is looking for suppliers of the following APIs: 1) Valsartan- 2800kg 2) Hydrochlorothiazide- 100 3) Zolpidem Tartrate- 50kg 4) Telmisartan- 250kg 5) Orlistat- 1300kg 6) Pravastatin Sodium- 1100kg 7) Ramipril- 1700 8) Olmesartan Medoxomil- 110kg 9) Lisinopril Dihydrate- 55kg 10) Gliclazide – 10150kg 11) Donepezil Hydrochloride- 125kg 12) Cinacalet Hydrochloride- 100kg 13) Dihydrocodeine Tartrate- 700kg 14) Paracetamol- 35200kg 15) Captopril- 25kg 16) Cimetidine- 800kg Interested suppliers must support this enquiry with CEP.

07 Aug 2018

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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USP

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Market Place

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

56 API Suppliers

25 USDMF

3 JDMF

20 EU WC

11 KDMF

19 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers

52 FDA Orange Book

70 Europe

34 Canada

30 Australia

2 South Africa

31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 30MG BASE

TABLET;ORAL - EQ 60MG BASE

TABLET;ORAL - EQ 90MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

1 DKSH

5 Boai NKY Pharmaceuticals Ltd

10 Gangwal Healthcare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

2 DFE Pharma

6 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

5 Kerry

9 Microlex e.U

2 Novo Excipients

3 Pharmatrans-Sanaq

3 Pluviaendo

2 Prachin Chemical

13 Roquette

1 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

8 Sigachi Industries

2 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Fillers, Diluents & Binders

30 Direct Compression

22 Disintegrants & Superdisintegrants

15 Thickeners and Stabilizers

15 Granulation

13 Co-Processed Excipients

11 Lubricants & Glidants

9 Solubilizers

8 Controlled & Modified Release

8 Chewable & Orodispersible Aids

5 Taste Masking

4 Coating Systems & Additives

3 Emulsifying Agents

2 Parenteral

2 Film Formers & Plasticizers

1 API Stability Enhancers

1 Rheology Modifiers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow

38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

46 Finished Drug Prices

16 Annual Reports

MARKET PLACE