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Chemistry

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Also known as: Meclizine hydrochloride, Meclizine dihydrochloride monohydrate, 31884-77-2, Postafen, Agyrax, Bonamine
Molecular Formula
C25H31Cl3N2O
Molecular Weight
481.9  g/mol
InChI Key
KDLHYOMCWBWLMM-UHFFFAOYSA-N
FDA UNII
HDP7W44CIO

Meclizine Hydrochloride
A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness.
1 2D Structure

Meclizine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[(4-chlorophenyl)-phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine;hydrate;dihydrochloride
2.1.2 InChI
InChI=1S/C25H27ClN2.2ClH.H2O/c1-20-6-5-7-21(18-20)19-27-14-16-28(17-15-27)25(22-8-3-2-4-9-22)23-10-12-24(26)13-11-23;;;/h2-13,18,25H,14-17,19H2,1H3;2*1H;1H2
2.1.3 InChI Key
KDLHYOMCWBWLMM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC(=CC=C1)CN2CCN(CC2)C(C3=CC=CC=C3)C4=CC=C(C=C4)Cl.O.Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
HDP7W44CIO
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Agyrax

2. Antivert

3. Bonamine

4. Bonine

5. Chiclida

6. D Vert

7. D-vert

8. Dihydrochloride, Meclizine

9. Dvert

10. Histametizyn

11. Hydrochloride, Meclizine

12. Meclizine

13. Meclizine Dihydrochloride

14. Meclizine Hydrochloride

15. Meclizine Monohydrochloride

16. Meclozine

17. Monohydrochloride, Meclizine

18. Parachloramine

19. Ru Vert M

20. Ru-vert-m

2.3.2 Depositor-Supplied Synonyms

1. Meclizine Hydrochloride

2. Meclizine Dihydrochloride Monohydrate

3. 31884-77-2

4. Postafen

5. Agyrax

6. Bonamine

7. Hdp7w44cio

8. Meclozine Hydrochloride Monohydrate

9. Ucb-5062

10. 1-[(4-chlorophenyl)-phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine;hydrate;dihydrochloride

11. Nsc-757094

12. Piperazine, 1-((4-chlorophenyl)phenylmethyl)-4-((3-methylphenyl)methyl)-, Dihydrochloride, Monohydrate

13. Mfcd00941489

14. Meclizine Hcl Hydrate

15. Nsc-28728

16. Unii-hdp7w44cio

17. Antivert (tn)

18. Chembl3989555

19. Chebi:31805

20. Dtxsid30953792

21. Meclizine Hydrochloride (jan/usp)

22. Meclizine Hydrochloride [usp:jan]

23. Bcp13363

24. Meclizine Hydrochloride [jan]

25. Meclizine Hydrochloride [vandf]

26. Nsc 757094

27. 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methylbenzyl)piperazine Dihydrochloride Monohydrate

28. Meclizine Hydrochloride [usp-rs]

29. As-13740

30. Meclizine Hydrochloride [orange Book]

31. D01317

32. Meclizine Hydrochloride [usp Monograph]

33. A821043

34. Meclizine Dihydrochloride Monohydrate [mi]

35. (+/-)-meclizine Dihydrochloride Monohydrate

36. Meclozine Hydrochloride Monohydrate [who-dd]

37. Meclizine Dihydrochloride Monohydrate, (+/-)-

38. Q27279880

39. 1-((4-chlorophenyl)(phenyl)methyl)-4-(3-methylbenzyl)piperazine Dihydrochloride Hydrate

40. 1-((4-chlorophenyl)(phenyl)methyl)-4-(3-methylbenzyl)piperazinedihydrochloridehydrate

41. 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methylbenzyl) Piperazine Dihydrochloride Monohydrate

42. 1-(p-chloro-.alpha.-phenylbenzyl)-4-(m-methylbenzyl)piperazine Dihydrochloride Monohydrate

43. 1-[(4-chlorophenyl)(phenyl)methyl]-4-[(3-methylphenyl)methyl]piperazine--hydrogen Chloride--water (1/2/1)

44. 1-[(4-chlorophenyl)-phenyl-methyl]-4-(m-tolylmethyl)piperazine Hydrate Dihydrochloride;meclizine Dihydrochloride Monohydrate

45. 1-[(4-chlorophenyl)phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine Dihydrochloride Hydrate

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 481.9 g/mol
Molecular Formula C25H31Cl3N2O
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass480.150197 g/mol
Monoisotopic Mass480.150197 g/mol
Topological Polar Surface Area7.5 Ų
Heavy Atom Count31
Formal Charge0
Complexity448
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameMECLIZINE HYDROCHLORIDE
Active IngredientMECLIZINE HYDROCHLORIDE
CompanyAMNEAL PHARMS (Application Number: A201451); EPIC PHARMA LLC (Application Number: A200294); JUBILANT CADISTA (Application Number: A040659); MYLAN PHARMS INC (Application Number: A202640); PAR PHARM (Application Number: A087127); PAR PHARM (Application Number: A087128); SANDOZ (Application Number: A084092); SANDOZ (Application Number: A084843)

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)


Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)


Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)


Cholinergic Antagonists

Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Emesis Suppression [PE]; Antiemetic [EPC]

API SUPPLIERS

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LGM Pharma

U.S.A

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Jai Radhe Sales

India

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Pharm-RX Chemical

U.S.A

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Tenatra Exports

India

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Harika Drugs

India

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Virtual BoothHarika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.

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THINQ Pharma-CRO PVT Ltd

India

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THINQ Pharma-CRO PVT Ltd

India

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Unichem Laboratories Limited

India

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ASCO GU
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Unichem Laboratories Limited

India

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UCB Pharma S.A

Belgium

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UCB Pharma S.A

Belgium

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UCB Pharma S.A

Belgium

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ASCO GU
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UCB Pharma S.A

Belgium

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F. Hoffmann-La Roche

Switzerland

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F. Hoffmann-La Roche

Switzerland

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USDMF

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01

Arlin Chemicals Inc

U.S.A

USDMF

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01

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 767

Submission : 1963-12-19

Status : Inactive

Type : II

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Kv Pharmaceutical Co

Switzerland

USDMF

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02

Kv Pharmaceutical Co

Switzerland
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6370

Submission : 1986-05-22

Status : Inactive

Type : II

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03

ASCO GU
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03

ASCO GU
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20470

Submission : 2007-04-23

Status : Inactive

Type : II

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ASCO GU
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05

Jubilant Pharmova Ltd

India

USDMF

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06

ASCO GU
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07

ASCO GU
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09

Ucb Pharma Sa

Belgium

USDMF

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Ucb Pharma Sa

Belgium
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3689

Submission : 1980-01-16

Status : Inactive

Type : II

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EU WC

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01

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Meclizine Hydrochloride USP

Date of Issue : 2022-08-16

Valid Till : 2025-08-13

Written Confirmation Number : WC-0229

Address of the Firm : Survey No. 270, Nawabpet Village, Shivampet Mandai, Medak District, Telangana-50...

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ASCO GU
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Meclozine Hydrochloride BP/Ph.Eur

Date of Issue : 2022-08-16

Valid Till : 2025-08-13

Written Confirmation Number : WC-0229

Address of the Firm : Survey No. 270, Nawabpet Village, Shivampet Mandai, Medak District, Telangana-50...

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ASCO GU
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Meclizine Hydrochloride USP

Date of Issue : 2020-06-18

Valid Till : 2022-08-13

Written Confirmation Number : WC-0229A2

Address of the Firm : Survey No.270, Nawabpet (V), Shivampet (M), Medak District, Telangana State, Ind...

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Meclizine Hydrochloride BP

Date of Issue : 2020-06-18

Valid Till : 2022-08-13

Written Confirmation Number : WC-0229A2

Address of the Firm : Survey No.270, Nawabpet (V), Shivampet (M), Medak District, Telangana State, Ind...

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Meclizine Hydrochloride BP/USP/Ph. Eur

Date of Issue : 2025-08-26

Valid Till : 2028-08-25

Written Confirmation Number : WC-0076

Address of the Firm : Plot No.5, Phase-IV, G.I.D.C, Industrial Area, Panoli-394116, Dist-Bharuch, Guja...

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Meclizine Hydrochloride Ph.Eur

Date of Issue : 2025-02-14

Valid Till : 2027-11-04

Written Confirmation Number : WC-0092

Address of the Firm : Plot No. 18, 56, 57, 58, KIADB Industrial Area, Nanjangud, 571 302, Dist: Mysore...

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Meclozine Dihydrochloride EP

Date of Issue : 2025-12-24

Valid Till : 2028-09-09

Written Confirmation Number : WC-0246

Address of the Firm : Plot No. 17/24, Plot No. 17/22, 17/23, 17/13, Taloja-410 208, Panvel, District- ...

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Symed Labs

India
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Symed Labs

India
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Meclizine Hydrochloride USP/Ph. Eur

Date of Issue : 2025-09-29

Valid Till : 2028-08-09

Written Confirmation Number : WC-0072

Address of the Firm : Unit-II, Plot No.: 25/B, Phase -III, Jeedimetla(V),Quthbullapur (M), Medchal -Ma...

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Meclizine Hydrochloride USP

Date of Issue : 2022-06-30

Valid Till : 2025-07-28

Written Confirmation Number : WC-0063

Address of the Firm : Plot No. 99, MIDC Area - Dhatav Roha, Dist. Raigad, Roha, Raigad-402116, Maharas...

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NDC API

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01

ASCO GU
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MECLIZINE HYDROCHLORIDE

NDC Package Code : 66639-014

Start Marketing Date : 2019-01-18

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ASCO GU
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MECLIZINE HYDROCHLORIDE

NDC Package Code : 65372-1137

Start Marketing Date : 2008-06-12

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MECLIZINE HYDROCHLORIDE ANHYDROUS

NDC Package Code : 51927-0228

Start Marketing Date : 2022-02-08

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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ASCO GU
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MECLIZINE HYDROCHLORIDE ANHYDROUS

NDC Package Code : 71554-010

Start Marketing Date : 2019-04-27

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ASCO GU
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MECLIZINE HYDROCHLORIDE

NDC Package Code : 49452-4390

Start Marketing Date : 2016-04-01

End Marketing Date : 2027-10-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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ASCO GU
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MECLIZINE HYDROCHLORIDE

NDC Package Code : 66326-809

Start Marketing Date : 2020-01-19

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ASCO GU
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MECLIZINE

NDC Package Code : 13746-102

Start Marketing Date : 2008-01-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MECLIZINE HYDROCHLORIDE

NDC Package Code : 66022-0114

Start Marketing Date : 1982-01-20

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MECLIZINE HYDROCHLORIDE

NDC Package Code : 54469-0002

Start Marketing Date : 2016-12-15

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MECLIZINE HYDROCHLORIDE

NDC Package Code : 68981-024

Start Marketing Date : 2021-04-21

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

LGM Pharma

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

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Meclizine Hydrochloride

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

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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02

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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Meclizine Hydrochloride

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Jai Radhe Sales

03

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Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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Meclizine Hydrochloride

About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...

Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a highly selective supplier qualification process, including direct visits to overseas manufacturers, to maintain high quality standards. Pharm-Rx’s growth is driven by a consistent focus on quality ingredients, competitive pricing, and customer service. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Pharm RX

04

  • fda
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Meclizine Hydrochloride

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Tenatra

05

Harika Drugs

India
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Virtual BoothHarika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.

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Meclizine Hydrochloride

About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...

Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilities. Our manufacturing unit is based near Hyderabad, which is equipped with the latest production equipment to produce super quality Bulk Drugs/APIs. Spread on the area of 18000 sq. m., our factory has high production capacity and as a result of which we are able to satisfy immediate and bulk requirements of our clients.
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Meclizine Hydrochloride

About the Company : CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been su...

CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been successfully inspected and approved by major regulatory authorities, including the USFDA, EDQM, WHO-Geneva, and other international agencies. The company has been a pioneer and industry leader in the manufacturing of APIs, particularly in the therapeutic areas of Anti-Tuberculosis, Anti-Malarial, and Macrolide segments, catering to the treatment of acute diseases.
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Meclizine HCl

About the Company : Jubilant Life Sciences Limited, is an integrated global pharmaceutical and life sciences company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmace...

Jubilant Life Sciences Limited, is an integrated global pharmaceutical and life sciences company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Life Science Ingredients. It also provides services in Contract Manufacturing of Sterile Injectables and Drug Discovery and Development. The Company’s strength lies in its unique offerings of Pharmaceutical and Life Sciences products and services across the value chain. Our success is an outcome of strategic focus on the pharmaceuticals and life sciences industry, moving up the pharmaceutical value chain for products.
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08

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Meclizine Hydrochloride

About the Company : Headquartered in Mumbai, Keshava Organics is a US FDA approved facility making select antihistamine active pharmaceutical ingredients.Our facility located 100 kms north of Mumbai i...

Headquartered in Mumbai, Keshava Organics is a US FDA approved facility making select antihistamine active pharmaceutical ingredients.Our facility located 100 kms north of Mumbai is audited from time to time and is approved by most multinational companies that use these products. The US FDA gave us their approval in September 2011 for all products manufactured at the facility. Our desire and constant quest for improvement in everything we do at Keshava , timely upgrading and improvement in the factory infrastructure has resulted in a consistent quality which has been acknowledged and appreciated by our valued clients.
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09

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Meclizine Hydrochloride

About the Company : Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharma...

Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharmaceuticals, Nishchem International Pvt. Ltd. (NIPL) stands on the virtue of revolutionizing the ends, as well as the means to safe and secure health. Medicinal drugs have always held an important place in the sphere of healing and treatment, with their applications ranging from diagnosis, treatment and cure right up to prophylaxis.
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10

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Meclizine Hydrochloride

About the Company : SRI KRISHNA PHARMA (SKPL) with exports to over 75 countries offers innovative solutions across the value-chain. The API Division, with 4 manufacturing facilities, offers APAP/Parac...

SRI KRISHNA PHARMA (SKPL) with exports to over 75 countries offers innovative solutions across the value-chain. The API Division, with 4 manufacturing facilities, offers APAP/Paracetamol, Domperidone, Frusemide, Glibenclamide and Folic Acid and Enalapril Maleate with COS/CEP. We also offer Glipizide, Phenylepherine, Meclizine and Doxylamine Succinae with DMFs. The formulation facility manufactures and markets Microencapsulated product and Direct Compression grades of APAP/Paracetamol, Ibuprofen, Metformin, Guaifenesin, Aspirin and Other APIs. SKPL facilities have been GMP approved by USFDA, TGA & E.U. Health Authorities (French/Italian).
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01-Jan-2022
26-Dec-2025
KGS
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Drugs in Development

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  • Development Update

Details:

Meclizine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Motion Sickness.


Lead Product(s): Meclizine Hydrochloride,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 23, 2020

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01

Medical Corps, Israel Defense Force

Country
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ASCO GU
Not Confirmed

Medical Corps, Israel Defense Force

Country
arrow
ASCO GU
Not Confirmed

Details : Meclizine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Motion Sickness.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 23, 2020

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  • Development Update

Details:

Scopolamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Drug-Related Side Effects and Adverse Reactions.


Lead Product(s): Scopolamine,Meclizine Hydrochloride

Therapeutic Area: Pharmacology/Toxicology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 01, 2017

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02

Medical Corps, Israel Defense Force

Country
arrow
ASCO GU
Not Confirmed

Medical Corps, Israel Defense Force

Country
arrow
ASCO GU
Not Confirmed

Details : Scopolamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Drug-Related Side Effects and Adverse Reactions.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 01, 2017

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  • Development Update

Details:

Meclizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Vertigo.


Lead Product(s): Meclizine Hydrochloride,Inapplicable

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 14, 2014

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03

Apsen Farmaceutica

Country
arrow
ASCO GU
Not Confirmed

Apsen Farmaceutica

Country
arrow
ASCO GU
Not Confirmed

Details : Meclizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Vertigo.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 14, 2014

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  • Development Update

Details:

Meclizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Smoking Cessation.


Lead Product(s): Meclizine Hydrochloride,Nicotine

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Philip Morris USA, Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 30, 2011

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Duke University

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ASCO GU
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Duke University

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Details : Meclizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Smoking Cessation.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 30, 2011

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INTERMEDIATE SUPPLIERS

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CAS Number : 303-26-4

End Use API : Meclizine Hydrochloride

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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FDF Dossiers

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

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Regulatory Info :

Registration Country : India

Meclizine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

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

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Registration Country : India

Meclizine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

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Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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Regulatory Info : DISCN

Registration Country : USA

MECLIZINE HYDROCHLORIDE

Brand Name : MECLIZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 1988-03-31

Application Number : 89674

Regulatory Info : DISCN

Registration Country : USA

Strides Pharma Science

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Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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Regulatory Info :

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Meclizine Hydrochloride

Brand Name : Meclizine Hydrochloride

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

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DELCOR ASSET

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DELCOR ASSET

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ASCO GU
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MECLIZINE HYDROCHLORIDE

Brand Name : ANTIVERT

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 1982-01-20

Application Number : 10721

Regulatory Info : RX

Registration Country : USA

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DELCOR ASSET

U.S.A
ASCO GU
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DELCOR ASSET

U.S.A
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ASCO GU
Not Confirmed

MECLIZINE HYDROCHLORIDE

Brand Name : ANTIVERT

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 1982-01-01

Application Number : 10721

Regulatory Info : RX

Registration Country : USA

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DELCOR ASSET

U.S.A
ASCO GU
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DELCOR ASSET

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ASCO GU
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MECLIZINE HYDROCHLORIDE

Brand Name : ANTIVERT

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 1982-01-01

Application Number : 10721

Regulatory Info : RX

Registration Country : USA

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08

DELCOR ASSET

U.S.A
ASCO GU
Not Confirmed
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DELCOR ASSET

U.S.A
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ASCO GU
Not Confirmed

MECLIZINE HYDROCHLORIDE

Brand Name : ANTIVERT

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Packaging :

Approval Date : 1982-01-01

Application Number : 10721

Regulatory Info : RX

Registration Country : USA

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09

ASCO GU
Not Confirmed
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ASCO GU
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MECLIZINE HYDROCHLORIDE

Brand Name : MECLIZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Packaging :

Approval Date : 2010-06-04

Application Number : 40659

Regulatory Info : RX

Registration Country : USA

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10

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

MECLIZINE HYDROCHLORIDE

Brand Name : MECLIZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Packaging :

Approval Date : 1997-01-30

Application Number : 40179

Regulatory Info : DISCN

Registration Country : USA

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 12.5MG

USFDA APPLICATION NUMBER - 10721

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 10721

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DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 10721

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ABOUT THIS PAGE

Looking for 31884-77-2 / Meclizine Hydrochloride API manufacturers, exporters & distributors?

Meclizine Hydrochloride manufacturers, exporters & distributors 1

92

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meclizine Hydrochloride manufacturer or Meclizine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Meclizine Hydrochloride API Price utilized in the formulation of products. Meclizine Hydrochloride API Price is not always fixed or binding as the Meclizine Hydrochloride Price is obtained through a variety of data sources. The Meclizine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Meclizine Hydrochloride

Synonyms

Meclizine dihydrochloride monohydrate, 31884-77-2, Postafen, Agyrax, Bonamine, Hdp7w44cio

Cas Number

31884-77-2

Unique Ingredient Identifier (UNII)

HDP7W44CIO

About Meclizine Hydrochloride

A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness.

Meclizine Hydrochloride Manufacturers

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

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

Meclizine Hydrochloride Suppliers

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

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

Meclizine Hydrochloride USDMF

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

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

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

Meclizine Hydrochloride CEP

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

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

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

Meclizine Hydrochloride WC

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

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

Meclizine Hydrochloride NDC

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

Finished drug products

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

Unfinished drugs

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

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

Compounded drug products

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

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

Meclizine Hydrochloride GMP

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

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

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

Meclizine Hydrochloride CoA

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

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

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

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