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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
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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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
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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
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USDMF
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 9530
Submission : 1992-01-03
Status : Inactive
Type : II
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Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm : Plot No. 35, 36, 38, 39,40,49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal- Malk...
Date of Issue : 2020-09-30
Valid Till : 2022-07-02
Written Confirmation Number : WC-0119A9
Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50, & 51, Phase IV, IDA, Jeedimetla, Medchal-Ma...
Date of Issue : 2022-06-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-247
Address of the Firm : Plot No. D-5/8, TTC Industrial Area, Turphe, Navi Mumbai-400705, Maharashtra Sta...
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No. 1, Hetero SEZ Infrastructure Ltd., Narasapuram, Visakhapatnam-531 081, ...
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm : N-211/2/10, MIDC, Boisar, Dist-Thane-401506, Mahrashtra
Date of Issue : 2022-10-27
Valid Till : 2025-07-22
Written Confirmation Number : WC-0167
Address of the Firm : Unit No.1, Plot No.187, IInd Phase, GIDC Vapi-396195, Dist-Valsad, India
Date of Issue : 2020-06-11
Valid Till : 2023-06-10
Written Confirmation Number : WC-0473
Address of the Firm : Unit-2, Plot No.1203, III Phase, GIDC, Vapi-396 195, Dist-Valsad, Gujarat, India
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm : Plot No 100 Sector 56, HSIIDC, Kundli district sonepat, Haryana
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm : Plot No.262, 263, IDA, Pashamylaram, Medak District, A.P
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 200 mg
Packaging : 25 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR DOC GENERIC
Dosage Form : Tablets
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Zovirax
Dosage Form : Antic-calc Tablet
Dosage Strength : 200 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Aciclovir Sandoz
Dosage Form : TABLET
Dosage Strength : 800 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Virupos
Dosage Form : Eye Gel
Dosage Strength : 30mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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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
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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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Cream
Dosage Strength : 50mg/g
Price Per Pack (Euro) : 9.7
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 200 mg
Price Per Pack (Euro) : 11.29
Published in :
Country : Italy
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Cream
Dosage Strength : 50mg/g
Price Per Pack (Euro) : 4.85
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 400 mg
Price Per Pack (Euro) : 9.01
Published in :
Country : Italy
RX/OTC/DISCN :
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 800 mg
Price Per Pack (Euro) : 25.04
Published in :
Country : Italy
RX/OTC/DISCN :
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 800 mg
Price Per Pack (Euro) : 25.04
Published in :
Country : Italy
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet
Dosage Strength : 200 mg
Price Per Pack (Euro) : 12.023
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet
Dosage Strength : 400 mg
Price Per Pack (Euro) : 37.554
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet
Dosage Strength : 800 mg
Price Per Pack (Euro) : 35.134
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN : RX
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
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A Acyclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acyclovir, including repackagers and relabelers. The FDA regulates Acyclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acyclovir 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 Acyclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acyclovir supplier is an individual or a company that provides Acyclovir active pharmaceutical ingredient (API) or Acyclovir finished formulations upon request. The Acyclovir suppliers may include Acyclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Acyclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acyclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Acyclovir active pharmaceutical ingredient (API) in detail. Different forms of Acyclovir DMFs exist exist since differing nations have different regulations, such as Acyclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acyclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Acyclovir USDMF includes data on Acyclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acyclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acyclovir suppliers with USDMF on PharmaCompass.
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 Acyclovir Drug Master File in Japan (Acyclovir JDMF) empowers Acyclovir 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 Acyclovir JDMF during the approval evaluation for pharmaceutical products. At the time of Acyclovir 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 Acyclovir suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Acyclovir Drug Master File in Korea (Acyclovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acyclovir. The MFDS reviews the Acyclovir KDMF as part of the drug registration process and uses the information provided in the Acyclovir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acyclovir 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 Acyclovir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acyclovir suppliers with KDMF on PharmaCompass.
A Acyclovir CEP of the European Pharmacopoeia monograph is often referred to as a Acyclovir Certificate of Suitability (COS). The purpose of a Acyclovir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acyclovir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acyclovir to their clients by showing that a Acyclovir CEP has been issued for it. The manufacturer submits a Acyclovir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acyclovir CEP holder for the record. Additionally, the data presented in the Acyclovir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acyclovir DMF.
A Acyclovir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acyclovir 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 Acyclovir suppliers with CEP (COS) on PharmaCompass.
A Acyclovir written confirmation (Acyclovir WC) is an official document issued by a regulatory agency to a Acyclovir manufacturer, verifying that the manufacturing facility of a Acyclovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acyclovir APIs or Acyclovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Acyclovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Acyclovir 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 Acyclovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acyclovir 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 Acyclovir 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 Acyclovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acyclovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acyclovir suppliers with NDC on PharmaCompass.
Acyclovir 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 Acyclovir 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 Acyclovir GMP manufacturer or Acyclovir GMP API supplier for your needs.
A Acyclovir CoA (Certificate of Analysis) is a formal document that attests to Acyclovir's compliance with Acyclovir specifications and serves as a tool for batch-level quality control.
Acyclovir CoA mostly includes findings from lab analyses of a specific batch. For each Acyclovir 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.
Acyclovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Acyclovir EP), Acyclovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acyclovir USP).
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