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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
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
| Molecular Weight | 481.9 g/mol |
|---|---|
| Molecular Formula | C25H31Cl3N2O |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 5 |
| Exact Mass | 480.150197 g/mol |
| Monoisotopic Mass | 480.150197 g/mol |
| Topological Polar Surface Area | 7.5 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 448 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
| 1 of 1 | |
|---|---|
| Drug Name | MECLIZINE HYDROCHLORIDE |
| Active Ingredient | MECLIZINE HYDROCHLORIDE |
| Company | AMNEAL 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) |
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.)
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-19
Pay. Date : 2015-03-27
DMF Number : 29161
Submission : 2015-03-31
Status : Active
Type : II
Certificate Number : R0-CEP 2019-020 - Rev 00
Issue Date : 2020-04-07
Type : Chemical
Substance Number : 622
Status : Suspended by Holder
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

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33504
Submission : 2019-03-15
Status : Active
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3689
Submission : 1980-01-16
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5045
Submission : 1983-11-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6370
Submission : 1986-05-22
Status : Inactive
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 767
Submission : 1963-12-19
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6370
Submission : 1986-05-22
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20470
Submission : 2007-04-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3665
Submission : 1979-12-21
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21987
Submission : 2008-12-05
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2847
Submission : 1977-02-04
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19419
Submission : 2006-04-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5045
Submission : 1983-11-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3689
Submission : 1980-01-16
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5050
Submission : 1983-07-28
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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...

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...

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...

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...

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...

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...

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- ...

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...

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...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

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

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...

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

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

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

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

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

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

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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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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...
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...
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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...
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...
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...

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...

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...

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...

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...

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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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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

Lead Product(s) : Meclizine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Meclizine Plasma Levels in Responders and Non-responders
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

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

Lead Product(s) : Scopolamine,Meclizine Hydrochloride
Therapeutic Area : Pharmacology/Toxicology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Motion Sickness Medications and Vestibular Time Constant
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

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

Lead Product(s) : Meclizine Hydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Contr...
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

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

Lead Product(s) : Meclizine Hydrochloride,Nicotine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Philip Morris USA, Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Meclizine as a Potential Smoking Cessation Treatment
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : India
Brand Name : Meclizine Hydrochloride
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : DISCN
Registration Country : USA
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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REF. STANDARDS & IMPURITIES
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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.
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.
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.
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.
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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.
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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.
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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).
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.
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.
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.
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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.
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).