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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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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

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

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Australia

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Listed Dossiers

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

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Regulatory FDF Prices

NA

MARKET PLACE

0

FDF

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

Chemistry

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Also known as: 8011-96-9, Zinc;iron(3+);oxygen(2-), Calamine lotion, Calamine [usp:jan], Tenderwrap, Medipack
Molecular Formula
Fe2O4Zn
Molecular Weight
241.1  g/mol
InChI Key
CPYIZQLXMGRKSW-UHFFFAOYSA-N

Calamine
1 2D Structure

Calamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
zinc;iron(3+);oxygen(2-)
2.1.2 InChI
InChI=1S/2Fe.4O.Zn/q2*+3;4*-2;+2
2.1.3 InChI Key
CPYIZQLXMGRKSW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
[O-2].[O-2].[O-2].[O-2].[Fe+3].[Fe+3].[Zn+2]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Calamine (pharmaceutical Preparation)

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2007-12-05
3 Chemical and Physical Properties
Molecular Weight 241.1 g/mol
Molecular Formula Fe2O4Zn
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass239.778671 g/mol
Monoisotopic Mass239.778671 g/mol
Topological Polar Surface Area4 Ų
Heavy Atom Count7
Formal Charge0
Complexity0
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count7
4 Pharmacology and Biochemistry
4.1 FDA Pharmacological Classification
4.1.1 Pharmacological Classes
Decreased Copper Ion Absorption [PE]; Copper Absorption Inhibitor [EPC]

API SUPPLIERS

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01

Dr. Paul Lohmann GmbH & Co. KGaA

Germany

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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02

S D Fine Chem Limited

India

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

PEGS Boston Summit
Not Confirmed
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S D Fine Chem Limited

India

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Muby Chem

India

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

PEGS Boston Summit
Not Confirmed
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Muby Chem

India

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

Anmol Chemicals

India

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

PEGS Boston Summit
Not Confirmed
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Anmol Chemicals

India

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

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PEGS Boston Summit
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

VIPOR CHEMICALS PRIVATE LTD

India

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

PEGS Boston Summit
Not Confirmed
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VIPOR CHEMICALS PRIVATE LTD

India

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Mehta Pharmaceutical Industries

India

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

PEGS Boston Summit
Not Confirmed
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Mehta Pharmaceutical Industries

India

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

Heilen Biopharm Pvt. Ltd

India

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

PEGS Boston Summit
Not Confirmed
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Heilen Biopharm Pvt. Ltd

India

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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08

Umicore

Germany

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

PEGS Boston Summit
Not Confirmed
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Umicore

Germany

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

Durham Chemicals Birtley

United Kingdom

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

PEGS Boston Summit
Not Confirmed
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Durham Chemicals Birtley

United Kingdom

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

Global Chemical Co. Ltd

Thailand

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

PEGS Boston Summit
Not Confirmed
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Global Chemical Co. Ltd

Thailand

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

arrow
PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

PEGS Boston Summit
Not Confirmed

01

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41773

Submission : 2025-06-14

Status : Active

Type : IV

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02

Muby Chem Private Ltd

India

USDMF

arrow
PEGS Boston Summit
Not Confirmed

02

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 42194

Submission : 2025-08-16

Status : Active

Type : IV

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03

Sd Fine Chem Ltd

India

USDMF

arrow
PEGS Boston Summit
Not Confirmed

03

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28683

Submission : 2014-09-29

Status : Active

Type : IV

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04

PEGS Boston Summit
Not Confirmed

04

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23022

Submission : 2009-05-20

Status : Inactive

Type : II

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Europe

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01

LCM Limited

Italy
PEGS Boston Summit
Not Confirmed
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LCM Limited

Italy
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PEGS Boston Summit
Not Confirmed

Calamine; Zinc Oxide

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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02

Thornton & Ross Limited

United Kingdom
PEGS Boston Summit
Not Confirmed
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Thornton & Ross Limited

United Kingdom
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PEGS Boston Summit
Not Confirmed

Calamine; Zinc Oxide

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

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03

Bell Sons & Co. (Druggists) Limited

Country
PEGS Boston Summit
Not Confirmed
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Bell Sons & Co. (Druggists) Limited

Country
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PEGS Boston Summit
Not Confirmed

Calamine; Zinc Oxide

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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04

Central Procurement & Supplies Unit

Country
PEGS Boston Summit
Not Confirmed
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Central Procurement & Supplies Unit

Country
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PEGS Boston Summit
Not Confirmed

Zinc Oxide; Calamine

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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Canada

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01

PEGS Boston Summit
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CALAMINE

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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02

PEGS Boston Summit
Not Confirmed
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CALAMINE

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

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KENVUE CANADA INC.

Country
PEGS Boston Summit
Not Confirmed
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KENVUE CANADA INC.

Country
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PEGS Boston Summit
Not Confirmed

CALAMINE

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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South Africa

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01

Adcock Ingram Limited

South Africa
PEGS Boston Summit
Not Confirmed
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Adcock Ingram Limited

South Africa
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PEGS Boston Summit
Not Confirmed

Calamine

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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02

Adcock Ingram Limited

South Africa
PEGS Boston Summit
Not Confirmed
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Adcock Ingram Limited

South Africa
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Not Confirmed

Calamine

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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03

PEGS Boston Summit
Not Confirmed
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Calamine

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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04

PEGS Boston Summit
Not Confirmed
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Calamine

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

Looking for 8011-96-9 / Calamine API manufacturers, exporters & distributors?

Calamine manufacturers, exporters & distributors 1

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.

API | Excipient name

Calamine

Synonyms

8011-96-9, Zinc;iron(3+);oxygen(2-), Calamine lotion, Calamine [usp:jan], Tenderwrap, Medipack

Cas Number

8011-96-9

Calamine lotion Manufacturers

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.

Calamine lotion Suppliers

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.

Calamine lotion USDMF

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 GMP

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.

Calamine lotion CoA

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).

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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