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Chemistry

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Also known as: Mls002637530, Hydrocortisoni acetas, Ncgc00183367-01, Chembl1715636, Schembl13026148, Hms2232p13
Molecular Formula
C23H32O6
Molecular Weight
404.5  g/mol
InChI Key
ALEXXDVDDISNDU-UHFFFAOYSA-N

Hydrocortisone Acetate
1 2D Structure

Hydrocortisone Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] acetate
2.1.2 InChI
InChI=1S/C23H32O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h10,16-18,20,26,28H,4-9,11-12H2,1-3H3
2.1.3 InChI Key
ALEXXDVDDISNDU-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(=O)OCC(=O)C1(CCC2C1(CC(C3C2CCC4=CC(=O)CCC34C)O)C)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Mls002637530

2. Hydrocortisoni Acetas

3. Ncgc00183367-01

4. Chembl1715636

5. Schembl13026148

6. Hms2232p13

7. Hms3373l06

8. Bbl033683

9. Stl301800

10. Akos001582713

11. Akos021734921

12. [2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] Acetate

13. Ac-12502

14. Smr001317857

15. Vs-12217

16. Ft-0627126

17. Ft-0667894

18. Ah-034/06873032

19. Pregn-4-ene-3,20-dione,11beta,17alpha,21-trihydroxy-,21 Acetate

20. 2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate

21. 2-{1,10-dihydroxy-9a,11a-dimethyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl}-2-oxoethyl Acetate

2.3 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 404.5 g/mol
Molecular Formula C23H32O6
XLogP32.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass404.21988874 g/mol
Monoisotopic Mass404.21988874 g/mol
Topological Polar Surface Area101 Ų
Heavy Atom Count29
Formal Charge0
Complexity786
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count7
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameHydrocortisone acetate
Drug LabelEpifoam (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 1...
Active IngredientHydrocortisone acetate
Dosage FormCream; Powder
RouteFor rx compounding; Topical
Strength100%; 2.5%
Market StatusPrescription
CompanyX Gen Pharms; Ferndale Labs

2 of 2  
Drug NameHydrocortisone acetate
Drug LabelEpifoam (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 1...
Active IngredientHydrocortisone acetate
Dosage FormCream; Powder
RouteFor rx compounding; Topical
Strength100%; 2.5%
Market StatusPrescription
CompanyX Gen Pharms; Ferndale Labs

API Reference Price

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NO.19, XINY CHINA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712169000,"product":"HYDROCORTISONE ACETATE PH.EUR.9.8 MICRO","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"TIANJIN JINJIN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"CIPLA","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"820","totalValueFC":"24745.1","currency":"USD","unitRateINR":"68880","date":"04-Apr-2024","totalValueINR":"2066400","totalValueInUsd":"24745.1","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"2873207","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Micronized","supplierPort":"TIANJIN","supplierAddress":"CO.,LTDNO 8 OF JINGFU ROAD, INDUSTRIALZONE OF ZHANGJIAWO TOWN, XIDING CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716748200,"product":"HYDROCORTISONE ACETATE EP\/USP","address":"110-B,ANDHERI INDUSTRIAL ESTATE","city":"ANDHERI(W),MUMBAI, MAHARASHTRA","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ADD BIOTEC","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"300","totalValueFC":"9107.5","currency":"USD","unitRateINR":"25305","date":"27-May-2024","totalValueINR":"759150","totalValueInUsd":"9107.5","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"3677875","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT TIANJIN Tianjin - 300171, , CHINASDNF CHINA","customerAddress":"110-B,ANDHERI INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719513000,"product":"HYDROCORTISONE ACETATE IP2022\/EP11\/USP43","address":"502 FLOOR 5 PLOT 7 2 JOLLY BHAWAN ,? NEW MARINE LINES CHURCHGATE MUMBAI CITY ,? MUMBAI , ?MUMBAI ,? MAHARASHTRA,? 400020","city":"","supplier":"HENAN LIHUA PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"ZHENGZHOU","customer":"B M CHEMIE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"338","totalValueFC":"17066.1","currency":"USD","unitRateINR":"28493.4","date":"28-Jun-2024","totalValueINR":"1424670","totalValueInUsd":"17066.1","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"4230819","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZHENGZHOU","supplierAddress":"MIDDLE OF HUANGHE STREET, ANYANG HIAN, , , CHINA CHINA","customerAddress":"502 FLOOR 5 PLOT 7 2 JOLLY BHAWAN ,? NEW MARINE LINES CHURCHGATE MUMBAI CITY ,? MUMBAI , ?MUMBAI ,? MAHARASHTRA,? 400020"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"HYDROCORTISONE ACETATE IP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"366","totalValueFC":"18488","currency":"USD","unitRateINR":"30908.7","date":"06-Jul-2024","totalValueINR":"1545435","totalValueInUsd":"18488","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"4364972","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT, TIANJIN 300171, CHINASDNF China","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723055400,"product":"HYDROCORTISONE ACETATE EP\/USP","address":"110-B,ANDHERI INDUSTRIAL ESTATE","city":"ANDHERI(W),MUMBAI, MAHARASHTRA","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ADD BIOTEC","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"290","totalValueFC":"14624.7","currency":"USD","unitRateINR":"24534","date":"08-Aug-2024","totalValueINR":"1226700","totalValueInUsd":"14624.7","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"4942220","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT TIANJIN Tianjin - 300171, , CHINASDNF CHINA","customerAddress":"110-B,ANDHERI INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723141800,"product":"HYDROCORTISONE ACETATE IP\/EP","address":"110-B,ANDHERI INDUSTRIAL ESTATE","city":"ANDHERI(W),MUMBAI, MAHARASHTRA","supplier":"TIANJIN JINJIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ADD BIOTEC","customerCountry":"INDIA","quantity":"130.00","actualQuantity":"130","unit":"KGS","unitRateFc":"285","totalValueFC":"37368.7","currency":"USD","unitRateINR":"24111","date":"09-Aug-2024","totalValueINR":"3134430","totalValueInUsd":"37368.7","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"4964299","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.08 OF JINGFU ROAD INDUSTRIAL ZONE OF ZHANGJIAWO TOWN XIQING DIST Tianjin, , CHINA CHINA","customerAddress":"110-B,ANDHERI INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733423400,"product":"HYDROCORTISONE ACETATE USP","address":"L-4, PHASE-III,","city":"AKOLA. MAHARASHTRA","supplier":"ZHEJIANG SACHEM PHARMACEUTICAL,","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"LEBEN LABORATORIES PRIVATE ","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"245","totalValueFC":"30870.5","currency":"USD","unitRateINR":"20984.3","date":"06-Dec-2024","totalValueINR":"2623031.25","totalValueInUsd":"30870.5","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"7077977","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"TECHNOLOGY CO., LTD. ROOM 1611,BUIL DING 7,CANAL FORTUNE CENTER,NO.99NO .99 SHENHUA ROAD,GONGSHU,DISTRICT,H CHINA","customerAddress":"L-4, PHASE-III,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735065000,"product":"HYDROCORTISONE ACETATE PH.EUR9.8 MICRO HYDROCORTISONE ACETATE PH.EUR9.8 MICRO","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"TIANJIN JINJIN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CIPLA","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"820","totalValueFC":"49768","currency":"USD","unitRateINR":"70479","date":"25-Dec-2024","totalValueINR":"4228740","totalValueInUsd":"49768","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"7445619","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Micronized","supplierPort":"BEIJING","supplierAddress":"CO.,LTD NO 8 OF JINGFU ROAD, INDUSTRIAL ZONE OF ZHANGJIAWO TOWN, XIDING CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"HYDROCORTISONE ACETATE IP2022\/EP11\/USP43 HYDROCORTISONE ACETATE IP2022\/EP11\/USP43","address":"502 FLOOR 5 PLOT 7 2 JOLLY BHAWAN ,? NEW MARINE LINES CHURCHGATE MUMBAI CITY ,? MUMBAI , ?MUMBAI ,? MAHARASHTRA,? 400020","city":"","supplier":"HENAN LIHUA PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"ZHENGZHOU","customer":"B M CHEMIE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"318","totalValueFC":"48181.7","currency":"USD","unitRateINR":"27697.8","date":"21-Jan-2025","totalValueINR":"4154670","totalValueInUsd":"48181.7","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"7909578","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZHENGZHOU","supplierAddress":"MIDDLE OF HUANGHE STREET, ANYANG HI #NAME? AN, , , CHINA","customerAddress":"502 FLOOR 5 PLOT 7 2 JOLLY BHAWAN ,? NEW MARINE LINES CHURCHGATE MUMBAI CITY ,? MUMBAI , ?MUMBAI ,? MAHARASHTRA,? 400020"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741113000,"product":"HYDROCORTISONE ACETATE IP\/EP HYDROCORTISONE ACETATE IP\/EP","address":"110-B,ANDHERI INDUSTRIAL ESTATE","city":"ANDHERI(W),MUMBAI, MAHARASHTRA","supplier":"TIANJIN JINJIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ADD BIOTEC","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"300","totalValueFC":"30392.2","currency":"USD","unitRateINR":"26325","date":"05-Mar-2025","totalValueINR":"2632500","totalValueInUsd":"30392.2","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"8710831","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.08 OF JINGFU ROAD INDUSTRIAL ZON E OF ZHANGJIAWO TOWN XIQING DIST Ti anjin, , CHINA CHINA","customerAddress":"110-B,ANDHERI INDUSTRIAL ESTATE"}]
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26-Mar-2025
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DOSAGE - AEROSOL, METERED;RECTAL - 10%

USFDA APPLICATION NUMBER - 17351

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DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50218

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DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML

USFDA APPLICATION NUMBER - 50356

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DOSAGE - AEROSOL, METERED;TOPICAL - 1%;1%

USFDA APPLICATION NUMBER - 86195

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ABOUT THIS PAGE

Looking for 42016-02-4 / Hydrocortisone Acetate API manufacturers, exporters & distributors?

Hydrocortisone Acetate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Hydrocortisone Acetate 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 Hydrocortisone Acetate manufacturer or Hydrocortisone Acetate supplier for your needs.

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

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

API | Excipient name

Hydrocortisone Acetate

Synonyms

Mls002637530, Hydrocortisoni acetas, Ncgc00183367-01, Chembl1715636, Schembl13026148, Hms2232p13

Cas Number

42016-02-4

Epifoam Manufacturers

A Epifoam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epifoam, including repackagers and relabelers. The FDA regulates Epifoam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epifoam 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 Epifoam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Epifoam Suppliers

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

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

Epifoam USDMF

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

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

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

Epifoam JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Epifoam Drug Master File in Japan (Epifoam JDMF) empowers Epifoam API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Epifoam JDMF during the approval evaluation for pharmaceutical products. At the time of Epifoam JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Epifoam suppliers with JDMF on PharmaCompass.

Epifoam KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Epifoam Drug Master File in Korea (Epifoam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epifoam. The MFDS reviews the Epifoam KDMF as part of the drug registration process and uses the information provided in the Epifoam KDMF to evaluate the safety and efficacy of the drug.

After submitting a Epifoam KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Epifoam API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Epifoam suppliers with KDMF on PharmaCompass.

Epifoam CEP

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

A Epifoam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epifoam 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 Epifoam suppliers with CEP (COS) on PharmaCompass.

Epifoam WC

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

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

Epifoam 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 Epifoam as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Epifoam 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 Epifoam 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 Epifoam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epifoam NDC to their finished compounded human drug products, they may choose to do so.

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

Epifoam GMP

Epifoam 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 Epifoam 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 Epifoam GMP manufacturer or Epifoam GMP API supplier for your needs.

Epifoam CoA

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

Epifoam CoA mostly includes findings from lab analyses of a specific batch. For each Epifoam 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.

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