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Chemistry

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Also known as:
Molecular Formula
C9H13N5O4
Molecular Weight
255.23  g/mol
InChI Key
IRSCQMHQWWYFCW-UHFFFAOYSA-N

Ganciclovir
1 2D Structure

Ganciclovir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one
2.1.2 InChI
InChI=1S/C9H13N5O4/c10-9-12-7-6(8(17)13-9)11-3-14(7)4-18-5(1-15)2-16/h3,5,15-16H,1-2,4H2,(H3,10,12,13,17)
2.1.3 InChI Key
IRSCQMHQWWYFCW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=NC2=C(N1COC(CO)CO)NC(=NC2=O)N
2.1.5 Isomeric SMILES
C1=NC2=C(N1COC(CO)CO)NC(=NC2=O)N
2.2 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 255.23 g/mol
Molecular Formula C9H13N5O4
XLogP3-1.7
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count5
Rotatable Bond Count5
Exact Mass255.09675391 g/mol
Monoisotopic Mass255.09675391 g/mol
Topological Polar Surface Area135 A^2
Heavy Atom Count18
Formal Charge0
Complexity346
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameCytovene
PubMed HealthGanciclovir (Injection)
Drug ClassesAntiviral
Drug LabelGanciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno...
Active IngredientGanciclovir sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyRoche Palo

2 of 6  
Drug NameGanciclovir
PubMed HealthGanciclovir
Drug ClassesAntiviral
Drug LabelGanciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s...
Active IngredientGanciclovir sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyFresenius Kabi Usa; Luitpold

3 of 6  
Drug NameZirgan
PubMed HealthGanciclovir
Drug ClassesAntiviral
Drug LabelZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu...
Active IngredientGanciclovir
Dosage FormGel
RouteOphthalmic
Strength0.15%
Market StatusPrescription
CompanyBausch And Lomb

4 of 6  
Drug NameCytovene
PubMed HealthGanciclovir (Injection)
Drug ClassesAntiviral
Drug LabelGanciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno...
Active IngredientGanciclovir sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyRoche Palo

5 of 6  
Drug NameGanciclovir
PubMed HealthGanciclovir
Drug ClassesAntiviral
Drug LabelGanciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s...
Active IngredientGanciclovir sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyFresenius Kabi Usa; Luitpold

6 of 6  
Drug NameZirgan
PubMed HealthGanciclovir
Drug ClassesAntiviral
Drug LabelZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu...
Active IngredientGanciclovir
Dosage FormGel
RouteOphthalmic
Strength0.15%
Market StatusPrescription
CompanyBausch And Lomb

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Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735669800,"product":"CBZ-VALINE GANCICLOVIR CBZ-VALINE GANCICLOVIR","address":"1706,17TH FL KESAR SOLITAIRE PLOT","city":"NAVI MUMBAI, MAHARASHTRA","supplier":"ANQING WORLD CHEMICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ENALTEC LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"380","totalValueFC":"37877","currency":"USD","unitRateINR":"32661","date":"01-Jan-2025","totalValueINR":"3266100","totalValueInUsd":"37877","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"7557970","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"NO.21 HUANCHENG WEST ROAD ANQING CITY ANHUI PROVINCE SDNF CN","customerAddress":"1706,17TH FL KESAR SOLITAIRE PLOT"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737916200,"product":"GANCICLOVIR USP GANCICLOVIR USP","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"HANGZHOU PROSERRE CHEMICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CAPLIN POINT LABORATORIES LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"450","totalValueFC":"2272.7","currency":"USD","unitRateINR":"39195","date":"27-Jan-2025","totalValueINR":"195975","totalValueInUsd":"2272.7","indian_port":"Madras Air","hs_no":"29335990","bill_no":"8031099","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Room 2002, Sunon Central Mansion, NO.200,Shimin Road, Jianggan, District, Hangzhou,Zhejiang, China.","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"VALGANCICLOVIR HCL IH","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"29.68","actualQuantity":"29.68","unit":"KGS","unitRateFc":"975.9","totalValueFC":"29009.7","currency":"USD","unitRateINR":"85000","date":"03-Feb-2025","totalValueINR":"2522800","totalValueInUsd":"29009.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"8152686","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"VALGANCICLOVIR HCL IH","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"269.85","actualQuantity":"269.85","unit":"KGS","unitRateFc":"975.9","totalValueFC":"263755.4","currency":"USD","unitRateINR":"85000","date":"03-Feb-2025","totalValueINR":"22937250","totalValueInUsd":"263755.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"8152686","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"GANCICLOVIR USP GANCICLOVIR USP","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"UNITED STATES","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"5300","totalValueFC":"53479","currency":"USD","unitRateINR":"465075","date":"21-Feb-2025","totalValueINR":"4650750","totalValueInUsd":"53479","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8482620","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 USA SDNF US","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"GANCICLOVIR RELATED COMPOUND A (QTY: 2 X 15 MG, VALUE: USD 1158\/EACH)(FOC)SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00003","unit":"KGS","unitRateFc":"78338766.7","totalValueFC":"2382.2","currency":"USD","unitRateINR":"6878143333","date":"07-Mar-2025","totalValueINR":"206344.3","totalValueInUsd":"2382.2","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"8760298","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704, SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"VALGANCICLOVIR HCL PH.EUR","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"149.86","actualQuantity":"149.86","unit":"KGS","unitRateFc":"968.1","totalValueFC":"147061.4","currency":"USD","unitRateINR":"85000","date":"10-Mar-2025","totalValueINR":"12738100","totalValueInUsd":"147061.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"8791418","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"VALGANCICLOVIR HCL PH.EUR","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"302.25","actualQuantity":"302.25","unit":"KGS","unitRateFc":"968.1","totalValueFC":"296605.5","currency":"USD","unitRateINR":"85000","date":"10-Mar-2025","totalValueINR":"25691250","totalValueInUsd":"296605.5","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"8791418","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743359400,"product":"VALGANCICLOVIR HCL USP (AMORPHOUS) VALGANCICLOVIR HCL USP (AMORPHOUS)","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"OLON S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"107.00","actualQuantity":"107","unit":"KGS","unitRateFc":"1400","totalValueFC":"150980.2","currency":"USD","unitRateINR":"122220","date":"31-Mar-2025","totalValueINR":"13077540","totalValueInUsd":"150980.2","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"9205115","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA RIVOLTANA KM 6\/7 20090 RODAN O MI IT Rodano, , Italy SDNF Italy","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743532200,"product":"VALGANCICLOVIR HCL PH.EUR","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"326.79","actualQuantity":"326.79","unit":"KGS","unitRateFc":"973.7","totalValueFC":"324492.7","currency":"USD","unitRateINR":"85000","date":"02-Apr-2025","totalValueINR":"27777150","totalValueInUsd":"324492.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"9237984","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748284200,"product":"GANCICLOVIR (AS PER DUAL USE LIC NO:NOC\/BADDI(SZ)\/2025\/000284 DT: 22\/04\/2025)GANCICLOVIR (AS PER DUAL USE LIC NO:NOC\/BADDI(SZ)\/2025\/00028","address":"2nd, 3rd & 4th FLOOR, PALLADIUM TOWER, ,? PLOT NO.181\/46, INDUSTRIAL AREA PHASE-1, ,? CHANDIGARH , ?CHANDIGARH ,? CHANDIGARH,? 160002","city":"","supplier":"LUNA CHEMICALS COLIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SYNTHIMED LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"400","totalValueFC":"608.4","currency":"USD","unitRateINR":"34560","date":"27-May-2025","totalValueINR":"51840","totalValueInUsd":"608.4","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"2305747","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"FLOOR 11TH CBD HANGZHOU YIN 2030 JI ANGHUI ROAD HANGZHOU ZHEJIANG CHINA Zhenjiang, , CHINA CHINA","customerAddress":"2nd, 3rd & 4th FLOOR, PALLADIUM TOWER, ,? PLOT NO.181\/46, INDUSTRIAL AREA PHASE-1, ,? CHANDIGARH , ?CHANDIGARH ,? CHANDIGARH,? 160002"}]
06-Jan-2022
27-May-2025
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ABOUT THIS PAGE

Looking for / Ganciclovir API manufacturers, exporters & distributors?

Ganciclovir manufacturers, exporters & distributors 1

17

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

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

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

API | Excipient name

Ganciclovir

Zirgan Manufacturers

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

Zirgan Suppliers

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

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

Zirgan USDMF

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

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

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

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

Zirgan CEP

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

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

Zirgan WC

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

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

Zirgan 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 Zirgan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Zirgan GMP

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

Zirgan CoA

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

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

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