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Cysteamine Bitartrate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 8 USDMF, 2 JDMF, 6 NDC API, 5 Listed Suppliers, $ API Reference Price

10 API Suppliers
8 USDMF
2 JDMF
6 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers, 6 FDA Orange Book, 10 Europe, 2 Canada

18 FDF Dossiers
6 FDA Orange Book
10 Europe
2 Canada

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE, CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

drugProductComposition
CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE
CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Evonik, 4 SPI Pharma, 8 DKSH, 4 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 13 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 16 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 31 Controlled & Modified Release, 22 Direct Compression, 19 Disintegrants & Superdisintegrants, 18 Thickeners and Stabilizers, 15 Lubricants & Glidants, 13 Granulation, 12 Taste Masking, 11 Film Formers & Plasticizers, 11 Co-Processed Excipients, 9 Empty Capsules, 6 Chewable & Orodispersible Aids, 6 Solubilizers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Topical, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents, 1 Parenteral

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 6 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
6 Finished Drug Prices

MARKET PLACE

7 APIs, 3 FDF Dossiers

marketPlace
7 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 8 US Exclusivities

patents
96 US Patents
8 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

43,406,510

Annual Reports (USD Million)

Finished Drug Prices

177 RELATED EXCIPIENT COMPANIES

302EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 27761-19-9, Cysteamine (bitartrate), Mercamine bitartrate, Chebi:50386, Rp-103, Schembl49513

Molecular Formula

C₆H₁₃NO₆S

Molecular Weight

227.24 g/mol

InChI Key

NSKJTUFFDRENDM-UHFFFAOYSA-N

A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.

1 2D Structure

Cysteamine Bitartrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-aminoethanethiol;2,3-dihydroxybutanedioic acid

2.1.2 InChI

InChI=1S/C4H6O6.C2H7NS/c5-1(3(7)8)2(6)4(9)10;3-1-2-4/h1-2,5-6H,(H,7,8)(H,9,10);4H,1-3H2

2.1.3 InChI Key

NSKJTUFFDRENDM-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C(CS)N.C(C(C(=O)O)O)(C(=O)O)O

2.2 Synonyms

2.2.1 MeSH Synonyms

1. 2 Aminoethanethiol

2. 2-aminoethanethiol

3. 35s-labeled Cysteamine

4. Becaptan

5. Beta Mercaptoethylamine

6. Beta-mercaptoethylamine

7. Bitartrate, Cysteamine

8. Cystagon

9. Cysteamine

10. Cysteamine Dihydrochloride

11. Cysteamine Hydrobromide

12. Cysteamine Hydrochloride

13. Cysteamine Maleate (1:1)

14. Cysteamine Tartrate

15. Cysteamine Tartrate (1:1)

16. Cysteamine Tosylate

17. Cysteamine, 35s Labeled

18. Cysteamine, 35s-labeled

19. Cysteinamine

20. Dihydrochloride, Cysteamine

21. Hydrobromide, Cysteamine

22. Hydrochloride, Cysteamine

23. Mercamine

24. Mercaptamine

25. Mercaptoethylamine

26. Tartrate, Cysteamine

27. Tosylate, Cysteamine

2.2.2 Depositor-Supplied Synonyms

1. 27761-19-9

2. Cysteamine (bitartrate)

3. Mercamine Bitartrate

4. Chebi:50386

5. Rp-103

6. Schembl49513

7. Chembl2062263

8. Bcp15048

9. Akos024332936

10. 2-aminoethanethiol 2,3-dihydroxysuccinate

11. Db-114321

12. Ft-0696891

13. 2-aminoethanethiol;2,3-dihydroxybutanedioic Acid

14. A900934

15. Q27122045

2.2.3 Other Synonyms

1. Cysteamine (usan)

2. Mecramine

2.3 Create Date

2007-12-05

3 Chemical and Physical Properties

Molecular Formula	C₆H₁₃NO₆S
Molecular Weight	227.24 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	4
Exact Mass	227.04635831 g/mol
Monoisotopic Mass	227.04635831 g/mol
Topological Polar Surface Area	142 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	144
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

Cystine Depleting Agents

Compounds and drugs that react with CYSTINE and convert it into a compound that can be more easily metabolized or intracellularly transported. Drugs in this class have been used to treat CYSTINOSIS. (See all compounds classified as Cystine Depleting Agents.)

4.2 FDA Pharmacological Classification

4.2.1 Pharmacological Classes

Cystine Disulfide Reduction [MoA]; Cystine Depleting Agent [EPC]

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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

DCAT Week

Attending

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF

Click Us!

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

02

Transo-Pharm Handels GmbH

Germany

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

PharmaVenue

Not Confirmed

Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

Contact Supplier

Germany

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF ASMF

AUDIT

03

Cambrex Corporation

U.S.A

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

PharmaVenue

Not Confirmed

04

Cambrex Corporation

U.S.A

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

PharmaVenue

Not Confirmed

05

ACIC Fine Chemicals

U.S.A

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

PharmaVenue

Not Confirmed

06

Lupin Ltd

India

India

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

PharmaVenue

Not Confirmed

10

Country

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

PharmaVenue

Not Confirmed

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

USDMF

01

Biophore India Pharmaceuticals Pvt L...

India

DCAT Week

Attending

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

India

Virtual Booth

Digital Content

CYSTEAMINE BITARTRATE

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37094

Submission : 2022-06-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Country

PharmaVenue

Not Confirmed

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JDMF

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NDC API

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Listed Suppliers

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API Reference Price

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AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"CYSTEAMINE HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1609525800,"product":"PURELIZZ CST-50 - CYSTEAMINE HYDROCHLORIDE 50% SOLUTION (FOR MANUFACTURING OF COSMETICS)","address":"D-9, SMA INDUSTRIAL AREA,G T KARNA L ROAD","city":"DELHI,DELHI","supplier":"OUTLET TRADERS IMP ","supplierCountry":"BRAZIL","foreign_port":"GUARULHOS","customer":"COSMO SASAKI CHEMICAL ","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"16.8","totalValueFC":"4142.9","currency":"USD","unitRateINR":"1515","date":"02-Jan-2021","totalValueINR":"302996.61","totalValueInUsd":"4142.9","indian_port":"DELHI AIR","hs_no":"29420090","bill_no":"2215188","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"GUARULHOS","supplierAddress":"","customerAddress":"D-9, SMA INDUSTRIAL AREA,G T KARNA L ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"CYSTEAMINE HCL","address":"8-2-348\/2,COC BUILDING,BESIDE-ADMN.TIVE STAFF COLLEGE,ROAD NO.3,","city":"BANJARA HILLS, HYDERABAD.AP","supplier":"JIANGSU GUOTAI INTERNATIONAL GROUP","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"3","totalValueFC":"61077.3","currency":"USD","unitRateINR":"223.4","date":"04-Jan-2021","totalValueINR":"4467000","totalValueInUsd":"61077.3","indian_port":"VIZAG SEA","hs_no":"29420026","bill_no":"2217458","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"","customerAddress":"8-2-348\/2,COC BUILDING,BESIDE-ADMN.TIVE STAFF COLLEGE,ROAD NO.3,"},{"dataSource":"API Import","activeIngredients":"CYSTEAMINE HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1611167400,"product":"CYSTEAMINE HYDROCHLORIDE","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"HONGRUI FINE CHEMICAL","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"7.3","totalValueFC":"2215.8","currency":"USD","unitRateINR":"540.2","date":"21-Jan-2021","totalValueINR":"162060","totalValueInUsd":"2215.8","indian_port":"MADRAS SEA","hs_no":"29309099","bill_no":"2441549","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1611685800,"product":"CYSTEAMINE HCL","address":"PLOT NO 19-111 ROAD NO 71,OPP BHAR ATIYA VIDYA BHAVAN PUBLIC SCHOOL","city":"JUBILEE HILLS HYDERABAD,TELANGANA","supplier":"ZHEJIANG MEDICINE CO LTD","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"SMS LIFESCIENCES","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"3.7","totalValueFC":"74721.6","currency":"USD","unitRateINR":"273.2","date":"27-Jan-2021","totalValueINR":"5464900","totalValueInUsd":"74721.6","indian_port":"MADRAS SEA","hs_no":"29309099","bill_no":"2513002","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"","customerAddress":"PLOT NO 19-111 ROAD NO 71,OPP BHAR ATIYA VIDYA BHAVAN PUBLIC SCHOOL"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1612549800,"product":"CYSTEAMINE HCL","address":"PLOT NO 19-111 ROAD NO 71,OPP BHAR ATIYA VIDYA BHAVAN PUBLIC SCHOOL","city":"JUBILEE HILLS HYDERABAD,TELANGANA","supplier":"LEVACHEM CO. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"16000.00","actualQuantity":"16000","unit":"KGS","unitRateFc":"3.5","totalValueFC":"55923.8","currency":"USD","unitRateINR":"292.9","date":"12-Sep-2024","totalValueINR":"4686480","totalValueInUsd":"55923.8","indian_port":"Vizag Sea","hs_no":"29420026","bill_no":"5567417","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"S IMPORT & EXPORT CO LTD 6-7\/F 310 NORTH ZHONGSHAN ROAD HANGZHOU CHINA","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"CYSTEAMINE HYDROCHLORIDE 95% MIN","address":"MATULYA CENTRE, A-2,GROUND FLOOR","city":"MUMBAI, MAHARASHTRA","supplier":"NORCHEM JIANGSU CORPORATION","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"SAJJAN INDIA LIMITED","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"3.5","totalValueFC":"70797.8","currency":"USD","unitRateINR":"298.7","date":"26-Nov-2024","totalValueINR":"5974500","totalValueInUsd":"70797.8","indian_port":"Ankleshwar","hs_no":"29309099","bill_no":"6891402","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"ROOM NO. 703,WANDA PLAZA B, NO. 106 MIDDLE JIANGDONG ROAD, NANJING-210017 CHINA","customerAddress":"MATULYA CENTRE, A-2,GROUND FLOOR"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE

USFDA APPLICATION NUMBER - 203389

DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 203389

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ABOUT THIS PAGE

Cysteamine Bitartrate Manufacturers

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

Cysteamine Bitartrate Suppliers

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

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

Cysteamine Bitartrate USDMF

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

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

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

Cysteamine Bitartrate 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 Cysteamine Bitartrate Drug Master File in Japan (Cysteamine Bitartrate JDMF) empowers Cysteamine Bitartrate 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 Cysteamine Bitartrate JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine Bitartrate 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 Cysteamine Bitartrate suppliers with JDMF on PharmaCompass.

Cysteamine Bitartrate 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 Cysteamine Bitartrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cysteamine Bitartrate GMP

Cysteamine Bitartrate 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 Cysteamine Bitartrate 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 Cysteamine Bitartrate GMP manufacturer or Cysteamine Bitartrate GMP API supplier for your needs.

Cysteamine Bitartrate CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

8 USDMF

2 JDMF

6 NDC API

5 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers

6 FDA Orange Book

10 Europe

2 Canada

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE

CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

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EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives

42 Fillers, Diluents & Binders

31 Controlled & Modified Release

22 Direct Compression

19 Disintegrants & Superdisintegrants

18 Thickeners and Stabilizers

15 Lubricants & Glidants

13 Granulation

12 Taste Masking

11 Film Formers & Plasticizers

11 Co-Processed Excipients

9 Empty Capsules

6 Chewable & Orodispersible Aids

6 Solubilizers

5 Coloring Agents

5 Emulsifying Agents

4 Vegetarian Capsules

4 API Stability Enhancers

4 Topical

3 Rheology Modifiers

2 Surfactant & Foaming Agents