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| Molecular Weight | 225.20 g/mol |
|---|---|
| Molecular Formula | C8H11N5O3 |
| XLogP3 | -1.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 225.08618923 g/mol |
| Monoisotopic Mass | 225.08618923 g/mol |
| Topological Polar Surface Area | 115 A^2 |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 308 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 2 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 3 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 4 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
| 5 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 6 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 7 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 8 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
API SUPPLIERS
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Temad- We think of world-class quality.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10124
Submission : 1993-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10710
Submission : 1994-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11974
Submission : 1996-05-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-04-22
DMF Number : 10685
Submission : 1994-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 8584
Submission : 1990-05-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2013-06-04
DMF Number : 10044
Submission : 1993-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-26
DMF Number : 11896
Submission : 1996-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10830
Submission : 1994-03-24
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11352
Submission : 1995-02-20
Status : Inactive
Type : II
Portfolio PDF
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Digital Content
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Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9530
Submission : 1992-01-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 1997-084 - Rev 12
Status : Valid
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1997-125 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2011-03-15
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2008-169 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-03-15
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 2003-041 - Rev 05
Status : Valid
Issue Date : 2020-10-20
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1998-126 - Rev 03
Status : Valid
Issue Date : 2017-04-27
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 2007-213 - Rev 01
Status : Valid
Issue Date : 2018-03-21
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2002-004 - Rev 01
Status : Expired
Issue Date : 2004-11-30
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1997-031 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2005-02-10
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1998-148 - Rev 05
Status : Valid
Issue Date : 2016-12-08
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2000-086 - Rev 01
Status : Expired
Issue Date : 2004-12-13
Type : Chemical
Substance Number : 968
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 306MF10109
Registrant's Address : Tongyuanxi, Dazhan, Xianju, Zhejiang Province, 317321, P. R. China.
Initial Date of Registration : 2024-08-07
Latest Date of Registration : 2024-08-07
Registration Number : 218MF10098
Registrant's Address : Tongyuanxi, Dazhan, Xianju, Zhejiang Province, 317321, P. R. China.
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2014-10-27
Registration Number : 218MF10016
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2022-01-11
Registration Number : 303MF10178
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2021-12-15
Latest Date of Registration : 2021-12-15
Registration Number : 217MF10746
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2015-07-13
Registration Number : 218MF10974
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2013-01-18
Registration Number : 221MF10178
Registrant's Address : 59, You Shih Road, Youth Industrial District, Dajia, Taichung, Taiwan 43767, R. O. C.
Initial Date of Registration : 2009-08-07
Latest Date of Registration : 2017-07-25
Registration Number : 221MF10074
Registrant's Address : 66 Guoshan Road, Xinshi Town, Deqing, Zhejiang, China
Initial Date of Registration : 2009-04-14
Latest Date of Registration : 2009-04-14
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Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuc...
Date of Issue : 2025-07-11
Valid Till : 2028-07-10
Written Confirmation Number : WC-0220
Address of the Firm : Plot N-37, Additional Ambernath Industrial Area, MIDC, Anand Nagar, MMR Zone-ll,...
Date of Issue : 2022-09-12
Valid Till : 2025-08-12
Written Confirmation Number : WC-0542
Address of the Firm : Plot No. 180/2 & 3, Khazipally (V), Jinnaram (M), Sangareddy - 502 319, Telangan...
Date of Issue : 2022-09-12
Valid Till : 2025-08-12
Written Confirmation Number : WC-0542
Address of the Firm : Plot No. 180/2 & 3, Khazipally (V), Jinnaram (M), Sangareddy - 502 319, Telangan...
Date of Issue : 2022-09-30
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...
Acyclovir for Injection (Lyophilsed Sterile Bulk) USP
Date of Issue : 2024-05-20
Valid Till : 2027-05-19
Written Confirmation Number : WC-0275
Address of the Firm : N-211/2/10, Taluka: MIDC Tarapur Boisar-401506, District: Thane-Zone 4, Maharash...
Date of Issue : 2024-03-21
Valid Till : 2027-03-20
Written Confirmation Number : WC-0473
Address of the Firm : Unit-2, Plot No 1203, Ill Phase GIDC, Vapi -396195, Dist.-Valsad, Gujarat, India
Date of Issue : 2024-04-23
Valid Till : 2027-04-01
Written Confirmation Number : WC-0420
Address of the Firm : Plot no. A-619 & 630, RIICO Industrial Area, Bhiwadi -301019, Dist -Alwar, Rajas...
Date of Issue : 2022-08-16
Valid Till : 2025-07-15
Written Confirmation Number : WC-0042N
Address of the Firm : Plot Nos. 262 to 271, IDA, Pashamylaram, Sangareddy District- 502 307, Telangana...
Date of Issue : 2021-12-16
Valid Till : 2024-05-20
Written Confirmation Number : WC-0303n
Address of the Firm : Plant-1, Plot No 1416 to 1421, 1507/1&2, 1601, Phase-lll, GIDC estate, Vapi, Val...
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
5'-Chloro-2'-nitro-N-phenylmalonanilic acid ethyl ...
CAS Number : 22316-45-6
End Use API : Acyclovir
About The Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API playe...
Together we can improve the quality of life
CAS Number : 75128-73-3
End Use API : Acyclovir
About The Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns tw...
(2S, 5S)-1yl amino)-3-methyl butanoyl) -5- Methyl ...
CAS Number : 59278-00-1
End Use API : Acyclovir
About The Company : Arde’s Laboratories Pvt Ltd. is a specialty pharmaceutical company that is engaged in the development, manufacture and marketing of generic pharmaceutical dru...
2-Oxa-1,4-butanediol diacetate
CAS Number : 59278-00-1
End Use API : Acyclovir
About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...
CAS Number : 75128-73-3
End Use API : Acyclovir
About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...
CAS Number : 75128-73-3
End Use API : Acyclovir
About The Company : Keminntek Laboratories is a Hyderabad (India) based Contract Research Organization in Pharmaceutical sector in specific Pharmaceutical Intermediates, Speciality...
CAS Number : 75123-73-3
End Use API : Acyclovir
About The Company : Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and imp...
2-(4-ethyl-3-iodophenyl)-2-Methylpropanoic acid
CAS Number : 1256584-73-2
End Use API : Acyclovir
About The Company : Shanghai Stepuppharm has a strong technical development troop and most of our technological backbone are Senior R&D persons and have more than 10 years experien...
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DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18828
DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federa...DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19909
DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - TABLET;ORAL - 800MG **Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
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PharmaCompass offers a list of Acyclovir 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 Acyclovir manufacturer or Acyclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acyclovir manufacturer or Acyclovir supplier.
PharmaCompass also assists you with knowing the Acyclovir API Price utilized in the formulation of products. Acyclovir API Price is not always fixed or binding as the Acyclovir Price is obtained through a variety of data sources. The Acyclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CS-1353 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CS-1353, including repackagers and relabelers. The FDA regulates CS-1353 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CS-1353 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 CS-1353 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CS-1353 supplier is an individual or a company that provides CS-1353 active pharmaceutical ingredient (API) or CS-1353 finished formulations upon request. The CS-1353 suppliers may include CS-1353 API manufacturers, exporters, distributors and traders.
click here to find a list of CS-1353 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CS-1353 DMF (Drug Master File) is a document detailing the whole manufacturing process of CS-1353 active pharmaceutical ingredient (API) in detail. Different forms of CS-1353 DMFs exist exist since differing nations have different regulations, such as CS-1353 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CS-1353 DMF submitted to regulatory agencies in the US is known as a USDMF. CS-1353 USDMF includes data on CS-1353's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CS-1353 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 CS-1353 Drug Master File in Japan (CS-1353 JDMF) empowers CS-1353 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 CS-1353 JDMF during the approval evaluation for pharmaceutical products. At the time of CS-1353 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CS-1353 Drug Master File in Korea (CS-1353 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CS-1353. The MFDS reviews the CS-1353 KDMF as part of the drug registration process and uses the information provided in the CS-1353 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CS-1353 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 CS-1353 API can apply through the Korea Drug Master File (KDMF).
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A CS-1353 CEP of the European Pharmacopoeia monograph is often referred to as a CS-1353 Certificate of Suitability (COS). The purpose of a CS-1353 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CS-1353 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CS-1353 to their clients by showing that a CS-1353 CEP has been issued for it. The manufacturer submits a CS-1353 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CS-1353 CEP holder for the record. Additionally, the data presented in the CS-1353 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CS-1353 DMF.
A CS-1353 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CS-1353 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 CS-1353 suppliers with CEP (COS) on PharmaCompass.
A CS-1353 written confirmation (CS-1353 WC) is an official document issued by a regulatory agency to a CS-1353 manufacturer, verifying that the manufacturing facility of a CS-1353 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CS-1353 APIs or CS-1353 finished pharmaceutical products to another nation, regulatory agencies frequently require a CS-1353 WC (written confirmation) as part of the regulatory process.
click here to find a list of CS-1353 suppliers with Written Confirmation (WC) on PharmaCompass.
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 CS-1353 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CS-1353 API and other APIs are published in this directory by the FDA.
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 CS-1353 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.
The NDC directory also contains data on finished compounded human drug products that contain CS-1353 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CS-1353 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CS-1353 suppliers with NDC on PharmaCompass.
CS-1353 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 CS-1353 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 CS-1353 GMP manufacturer or CS-1353 GMP API supplier for your needs.
A CS-1353 CoA (Certificate of Analysis) is a formal document that attests to CS-1353's compliance with CS-1353 specifications and serves as a tool for batch-level quality control.
CS-1353 CoA mostly includes findings from lab analyses of a specific batch. For each CS-1353 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.
CS-1353 may be tested according to a variety of international standards, such as European Pharmacopoeia (CS-1353 EP), CS-1353 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CS-1353 USP).
