Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers


1. Calamine (pharmaceutical Preparation)
1. 8011-96-9
2. Zinc;iron(3+);oxygen(2-)
3. Calamine Lotion
4. Calamine [usp:jan]
5. Tenderwrap
6. Medipack
7. Reliamed
8. Primer
9. Repara
10. Calamine (pharmaceutical Preparation)
11. Dtxsid9051612
12. Ft-0657528
13. Iron Oxide (fe2o3), Mixture With Zinc Oxide
| Molecular Weight | 241.1 g/mol |
|---|---|
| Molecular Formula | Fe2O4Zn |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 0 |
| Exact Mass | 239.778671 g/mol |
| Monoisotopic Mass | 239.778671 g/mol |
| Topological Polar Surface Area | 4 Ų |
| Heavy Atom Count | 7 |
| Formal Charge | 0 |
| Complexity | 0 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 7 |
Dr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28683
Submission : 2014-09-29
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42194
Submission : 2025-08-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41773
Submission : 2025-06-14
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23022
Submission : 2009-05-20
Status : Inactive
Type : II






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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41773
Submission : 2025-06-14
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42194
Submission : 2025-08-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28683
Submission : 2014-09-29
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23022
Submission : 2009-05-20
Status : Inactive
Type : II

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Calamine Lotion Bp
Dosage Form : Cutaneous Suspension
Dosage Strength : 2.5%W/V; 15%W/V
Packaging :
Approval Date : 2006-10-31
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Invalid
Registration Country : Malta
Brand Name : Aqueous Calamine
Dosage Form : Cream
Dosage Strength : 4.0%W/W; 3.0%W/W
Packaging :
Approval Date : 2016-08-04
Application Number :
Regulatory Info : Invalid
Registration Country : Malta

Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Calamine Lotion Bp
Dosage Form : Cutaneous Suspension
Dosage Strength : 100%W/V; 15%W/V
Packaging :
Approval Date : 2006-05-31
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Corporate PDF
Regulatory Info : Invalid
Registration Country : Malta
Brand Name : Calamine Lotion Bp
Dosage Form : Cutaneous Solution
Dosage Strength : 5%W/V; 15%W/V
Packaging :
Approval Date : 2020-02-20
Application Number :
Regulatory Info : Invalid
Registration Country : Malta

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Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Brand Name : LOTION CALAMINE AVEC ANTIHISTAMINIQUE
Dosage Form : SUSPENSION
Dosage Strength : 8%
Packaging : 150ML
Approval Date :
Application Number : 2241462
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada

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Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Brand Name : CALAMINE LOTION WITH ANTIHISTAMINE
Dosage Form : SUSPENSION
Dosage Strength : 8%
Packaging : 150ML
Approval Date :
Application Number : 538493
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada

Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Brand Name : AVEENO ANTI-ITCH LOTION
Dosage Form : LOTION
Dosage Strength : 3%/W/W
Packaging :
Approval Date :
Application Number : 2240105
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada

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Virtual Booth
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Calasthetic
Dosage Form : CRE
Dosage Strength : 1200mg/10g
Packaging : 35X1mg/10g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Biohist Lotion (Un Boxed)
Dosage Form : LIT
Dosage Strength : 150mg/ml
Packaging : 100X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Caladryl
Dosage Form : LOT
Dosage Strength : 10mg
Packaging : 100X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Caladryl
Dosage Form : CRE
Dosage Strength : 10mg/ml
Packaging : 42X1mg/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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ABOUT THIS PAGE
34
PharmaCompass offers a list of Calamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calamine manufacturer or Calamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calamine manufacturer or Calamine supplier.
A Calamine lotion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calamine lotion, including repackagers and relabelers. The FDA regulates Calamine lotion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calamine lotion 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 Calamine lotion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Calamine lotion supplier is an individual or a company that provides Calamine lotion active pharmaceutical ingredient (API) or Calamine lotion finished formulations upon request. The Calamine lotion suppliers may include Calamine lotion API manufacturers, exporters, distributors and traders.
click here to find a list of Calamine lotion suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Calamine lotion DMF (Drug Master File) is a document detailing the whole manufacturing process of Calamine lotion active pharmaceutical ingredient (API) in detail. Different forms of Calamine lotion DMFs exist exist since differing nations have different regulations, such as Calamine lotion USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calamine lotion DMF submitted to regulatory agencies in the US is known as a USDMF. Calamine lotion USDMF includes data on Calamine lotion's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calamine lotion USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calamine lotion suppliers with USDMF on PharmaCompass.
Calamine lotion 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 Calamine lotion GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calamine lotion GMP manufacturer or Calamine lotion GMP API supplier for your needs.
A Calamine lotion CoA (Certificate of Analysis) is a formal document that attests to Calamine lotion's compliance with Calamine lotion specifications and serves as a tool for batch-level quality control.
Calamine lotion CoA mostly includes findings from lab analyses of a specific batch. For each Calamine lotion 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.
Calamine lotion may be tested according to a variety of international standards, such as European Pharmacopoeia (Calamine lotion EP), Calamine lotion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calamine lotion USP).