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Chemistry

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Also known as: 182349-12-8, Rupatadin fumarate, Rupafin, Ur-12592 fumarate, Rupatadine (fumarate), Alergoliber
Molecular Formula
C30H30ClN3O4
Molecular Weight
532.0  g/mol
InChI Key
JYBLCDXVHQWMSU-WLHGVMLRSA-N
FDA UNII
XJ6OT32M93

Rupatadine Fumarate
1 2D Structure

Rupatadine Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;13-chloro-2-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene
2.1.2 InChI
InChI=1S/C26H26ClN3.C4H4O4/c1-18-13-19(16-28-15-18)17-30-11-8-20(9-12-30)25-24-7-6-23(27)14-22(24)5-4-21-3-2-10-29-26(21)25;5-3(6)1-2-4(7)8/h2-3,6-7,10,13-16H,4-5,8-9,11-12,17H2,1H3;1-2H,(H,5,6)(H,7,8)/b;2-1+
2.1.3 InChI Key
JYBLCDXVHQWMSU-WLHGVMLRSA-N
2.1.4 Canonical SMILES
CC1=CC(=CN=C1)CN2CCC(=C3C4=C(CCC5=C3N=CC=C5)C=C(C=C4)Cl)CC2.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC1=CC(=CN=C1)CN2CCC(=C3C4=C(CCC5=C3N=CC=C5)C=C(C=C4)Cl)CC2.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
XJ6OT32M93
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 182349-12-8

2. Rupatadin Fumarate

3. Rupafin

4. Ur-12592 Fumarate

5. Rupatadine (fumarate)

6. Alergoliber

7. Rinialer

8. Xj6ot32m93

9. 182349-12-8 (fumarate)

10. Rupax

11. 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine Fumarate

12. Rupatadine Fumarate (jan)

13. 1217234-48-4

14. Rupatadine Fumarate [jan]

15. (2e)-but-2-enedioic Acid; 13-chloro-2-{1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene}-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(15),3,5,7,11,13-hexaene

16. 5h-benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-, (2e)-2-butenedioate (1:1)

17. Mfcd00926499

18. Unii-xj6ot32m93

19. Rupatall

20. Tamalis

21. Wystamm

22. Ralif

23. Rinialer (tn)

24. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(1-((5-methyl-3-pyridinyl)methyl)-4-piperidinylidene)-, (2e)-2-butenedioate (1:1)

25. Rupafin (tn)

26. Rupatadine Fumarate- Bio-x

27. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 6,11-dihydro-8-chloro-11-(1-((5-methyl-3-pyridinyl)methyl)-4-piperidinylidene)-, (e)-2-butenedioate (1:1)

28. 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridyl)methyl]-4-piperidylidene]-5h-benzo[5,6]cyclohepta[1,2-b]pyridine Fumarate

29. Mls006010150

30. Schembl180121

31. Schembl180512

32. Rupatadine Fumarate [mi]

33. Hms3885k05

34. Bcp05230

35. Hy-13511a

36. Rupatadine Fumarate [who-dd]

37. S3052

38. Akos005145898

39. Ac-9016

40. Ccg-269922

41. Cs-3482

42. F76r825

43. Ks-1229

44. Br164385

45. Rupatadine Fumarate [ep Monograph]

46. Smr004701267

47. Sw219889-1

48. C73520

49. D08497

50. Q-201688

51. Q27293863

52. (e)-but-2-enedioic Acid;13-chloro-2-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene

2.4 Create Date
2006-04-29
3 Chemical and Physical Properties
Molecular Weight 532.0 g/mol
Molecular Formula C30H30ClN3O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count4
Exact Mass531.1924841 g/mol
Monoisotopic Mass531.1924841 g/mol
Topological Polar Surface Area104 Ų
Heavy Atom Count38
Formal Charge0
Complexity728
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Treatment of allergic rhinitis, Treatment of chronic idiopathic urticaria


API SUPPLIERS

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USDMF

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Duphat
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Urquima Sa

Spain

USDMF

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Urquima Sa

Spain
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36047

Submission : 2021-08-09

Status : Active

Type : II

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CEP/COS

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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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CEP 2021-095 - Rev 00
Valid
Chemical
2024-07-10
2888
Inabata Company Banner

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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Certificate Number : CEP 2021-095 - Rev 00

Status : Valid

Issue Date : 2024-07-10

Type : Chemical

Substance Number : 2888

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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CEP 2023-016 - Rev 00
Valid
Chemical
2024-07-09
2888
Biophore

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Certificate Number : CEP 2023-016 - Rev 00

Status : Valid

Issue Date : 2024-07-09

Type : Chemical

Substance Number : 2888

Biophore

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JDMF

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Rupatadine fumarate (for manufacturing purposes only)

Registration Number : 306MF10071

Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA

Initial Date of Registration : 2024-05-29

Latest Date of Registration : 2024-05-29

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Rupatadine Fumarate

Registration Number : 228MF10183

Registrant's Address : Poli(´)gon Industrial Riera de Caldes Avinguda Cami(´) Reial 51-57 08184 Palau-Soli...

Initial Date of Registration : 2016-09-09

Latest Date of Registration : 2017-06-30

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EU WC

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Rupatadin Fumarate EP

Date of Issue : 2022-09-01

Valid Till : 2025-07-02

Written Confirmation Number : WC-0074

Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India

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Rupatadin Fumarate EP

Date of Issue : 2019-07-29

Valid Till : 2022-07-02

Written Confirmation Number : WC-0074A1

Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India

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Rupatadine Fumarate EP / IH

Date of Issue : 2022-12-16

Valid Till : 2025-12-15

Written Confirmation Number : WC-0544

Address of the Firm : Plot No. 825,826,827, Industrial Area, Sector-Ill, Pithampur,\\r\\nDhar-454774, ...

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FDC

India
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FDC

India
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Rupatadine Fumarate (IH)

Date of Issue : 2022-06-08

Valid Till : 2025-07-07

Written Confirmation Number : WC-0055

Address of the Firm : Plot No. 19, 20/2, MIDC Area, Dhatav, Roha, Dist. Raigad

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Rupatadin Fumarate IH/EP

Date of Issue : 2022-06-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0231

Address of the Firm : D No.6/223 Sarpavaram Kakinada AP

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Rupatadine Fumarate EP

Date of Issue : 2022-06-15

Valid Till : 2025-07-14

Written Confirmation Number : WC-0183nA2

Address of the Firm : Unit -II, Plot No.79,\r\n\r\nJawaharlal Nehru Pharmacity,\r\n\r\nThanam Village,...

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Rupatadin Fumarate (Ph.Eur)

Date of Issue : 2019-07-15

Valid Till : 2022-07-14

Written Confirmation Number : WC-0183

Address of the Firm : Unit-II, Plot No.79, Jawaharlal Nehru Pharma City, Thanam Village, Parawad Manda...

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Listed Suppliers

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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Rupatadine Fumarate

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.
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LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Rupatadine Fumarate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

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Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

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Rupatadine Fumarate

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
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Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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Rupatadine Fumarate

About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
Tagoor Laboratories

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Rupatadine Fumarate

About the Company : Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable ...

Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.
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DEAFARMA

Italy
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DEAFARMA

Italy
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Rupatadine Fumarate

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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FDC

India
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FDC

India
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Rupatadine Fumarate

About the Company : FDC continues to uphold the pioneering spirit of its founding vision, achieving accreditations from esteemed regulatory bodies such as the US-FDA, UK-MHRA, MCC-RSA, and UAE authori...

FDC continues to uphold the pioneering spirit of its founding vision, achieving accreditations from esteemed regulatory bodies such as the US-FDA, UK-MHRA, MCC-RSA, and UAE authorities, among others. As a leader in the production of ORS and ophthalmic products, FDC has established globally approved manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms across multiple locations. These facilities are situated in Roha, Waluj, and Sinnar in Maharashtra, Verna in Goa, and Baddi in Himachal Pradesh. With a diverse portfolio of over 300 products, FDC exports its offerings to more than 50 countries worldwide.
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Rupatadine Fumarate

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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Noucor

Spain
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Noucor

Spain
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Rupatadine

About the Company : NOUCOR, headquartered near Barcelona, is a forward-thinking chemical-pharmaceutical company with a rich history spanning nearly two centuries. We operate three specialized manufact...

NOUCOR, headquartered near Barcelona, is a forward-thinking chemical-pharmaceutical company with a rich history spanning nearly two centuries. We operate three specialized manufacturing plants: Urquima, dedicated to fine chemicals and active ingredient production, a pharmaceutical plant, and a facility exclusively for food supplements. Employing over 500 people, NOUCOR is driven by innovation, focusing on research, development, licensing, manufacturing, and supply of high-quality pharmaceutical products to meet global healthcare needs.
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Rupatadine Fumarate

About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...

Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals Ingredients (API'S) for wide range of therapeutic categories. Therapeutic segments of focus are Anti Fungals, Anti Depressants, and Anti Hypertensive. Synergene manufacturing facilities are cGMP compliant meeting global standards in terms of infrastructure and systems. The company has two manufacturing facilities located at Hyderabad & Vishakhapatnam manufacturing Active Pharmaceutical Ingredients and Intermediates.
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API Reference Price

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02-Jan-2021
29-Nov-2024
KGS
overview
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Average Price (USD/KGS)

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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South Africa

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01

Duphat
Not Confirmed
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Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupallerg10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Duphat
Not Confirmed
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Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupallerg10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Duphat
Not Confirmed
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Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupanase Junior

Dosage Form : SOL

Dosage Strength : 1g/1ml

Packaging : 120X1g/1ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Duphat
Not Confirmed
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Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupanase 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Duphat
Not Confirmed
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arrow
Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupanase 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Duphat
Not Confirmed
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Duphat
Not Confirmed

Rupatadine Fumarate

Brand Name : Rupanase 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Pharma Q (Pty) Ltd

South Africa
Duphat
Not Confirmed
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Pharma Q (Pty) Ltd

South Africa
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Duphat
Not Confirmed

Rupatadine

Brand Name : Zealargy

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Pharma Q (Pty) Ltd

South Africa
Duphat
Not Confirmed
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Pharma Q (Pty) Ltd

South Africa
arrow
Duphat
Not Confirmed

Rupatadine

Brand Name : Zealargy

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Duphat
Not Confirmed
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Duphat
Not Confirmed

RUPATADINE

Brand Name : RAZTROL

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Duphat
Not Confirmed
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Duphat
Not Confirmed

RUPATADINE

Brand Name : RAZTROL

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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