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Molecular Weight | 277.28 g/mol |
---|---|
Molecular Formula | C12H15N5O3 |
XLogP3 | -0.8 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 277.11748936 g/mol |
Monoisotopic Mass | 277.11748936 g/mol |
Topological Polar Surface Area | 126 A^2 |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 480 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 4 | |
---|---|
Drug Name | Baraclude |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | 0.5mg; 0.05mg/ml; 1mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
2 of 4 | |
---|---|
Drug Name | Entecavir |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg |
Market Status | Prescription |
Company | Teva Pharms Usa |
3 of 4 | |
---|---|
Drug Name | Baraclude |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | 0.5mg; 0.05mg/ml; 1mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
4 of 4 | |
---|---|
Drug Name | Entecavir |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg |
Market Status | Prescription |
Company | Teva Pharms Usa |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33490
Submission : 2019-05-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-21
Pay. Date : 2014-10-14
DMF Number : 27848
Submission : 2014-01-07
Status : Active
Type : II
NDC Package Code : 64220-160
Start Marketing Date : 2024-09-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-13
Pay. Date : 2014-03-12
DMF Number : 27600
Submission : 2014-02-26
Status : Active
Type : II
Registration Number : 228MF10066
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2016-02-29
Latest Date of Registration :
NDC Package Code : 63126-903
Start Marketing Date : 2014-02-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2013-11-21
DMF Number : 27719
Submission : 2013-12-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-07
Pay. Date : 2013-10-30
DMF Number : 25200
Submission : 2011-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-152 - Rev 00
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2815
Status : Valid
Registration Number : 227MF10302
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2015-12-28
Latest Date of Registration :
NDC Package Code : 76397-001
Start Marketing Date : 2015-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27444
Submission : 2013-11-20
Status : Inactive
Type : II
Certificate Number : CEP 2018-006 - Rev 01
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2815
Status : Valid
NDC Package Code : 13612-0020
Start Marketing Date : 2020-09-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24305
Submission : 2010-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-08-27
DMF Number : 27401
Submission : 2013-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-12
Pay. Date : 2013-05-21
DMF Number : 24601
Submission : 2011-01-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 23663
Submission : 2010-05-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-03-18
DMF Number : 26307
Submission : 2012-08-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27066
Submission : 2013-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2013-11-21
DMF Number : 27719
Submission : 2013-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-28
Pay. Date : 2013-07-02
DMF Number : 25549
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27444
Submission : 2013-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-03-12
DMF Number : 27600
Submission : 2014-02-26
Status : Active
Type : II
Certificate Number : CEP 2021-083 - Rev 01
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-043 - Rev 01
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-283 - Rev 01
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-051 - Rev 00
Status : Valid
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-093 - Rev 01
Status : Valid
Issue Date : 2025-01-15
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-271 - Rev 05
Status : Valid
Issue Date : 2025-05-19
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-001 - Rev 01
Status : Valid
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-006 - Rev 01
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-152 - Rev 00
Status : Valid
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2815
Registration Number : 228MF10043
Registrant's Address : 2395 Speakman Drive Mississauga, Ontario, Canada L5K 1B3
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2016-02-08
Registration Number : 228MF10118
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2016-06-24
Latest Date of Registration : 2016-06-24
Registration Number : 228MF10062
Registrant's Address : 3 Hua Nanyi Road Chongqing (Changshou) Chemical Industrial Park Chongqing 401254
Initial Date of Registration : 2016-02-24
Latest Date of Registration : 2022-04-13
Registration Number : 227MF10257
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2015-10-21
Latest Date of Registration : 2016-11-15
Registration Number : 228MF10041
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2019-01-10
Registration Number : 225MF10215
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2013-12-03
Latest Date of Registration : 2016-11-02
Registration Number : 228MF10067
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-02-29
Latest Date of Registration : 2025-06-04
Registration Number : 228MF10026
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2016-02-02
Registration Number : 228MF10037
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2022-06-01
Entecavir monohydrate "Yung Shin"
Registration Number : 228MF10066
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2016-02-29
Latest Date of Registration : 2016-02-29
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
Registrant Name : Dasan Pharmaceutical Co., Ltd.
Registration Date : 2011-06-30
Registration Number : 763-5-ND
Manufacturer Name : Dasan Pharmaceutical Co., Lt...
Manufacturer Address : 342 Deokamsan-ro, Dogomyeon, Asan-si, Chungcheongnam-do @No.128 Chuhua Branch Road, F...
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2011-11-25
Registration Number : 787-2-ND
Manufacturer Name : Hanseochem Co., Ltd. @ [Star...
Manufacturer Address : Gyeonggi-do, Pyeongtaek-si, Poseung-eup, Poseung Industrial Complex Road 41@[Starting...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2015-07-27
Registration Number : Su5898-2-ND
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy. No. 213, 214 & 255, Bonthapally village, Gummadidala Mandal, Sangareddy District,...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2017-09-12
Registration Number : Su21-4-ND
Manufacturer Name : BrightGene Pharmaceutical Co...
Manufacturer Address : No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-11-18
Registration Number : Su2417-2-ND
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : 57, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2011-04-29
Registration Number : 21-5-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong, e...
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2012-08-14
Registration Number : 1962-4-ND
Manufacturer Name : Estech Pharma Co., Ltd.
Manufacturer Address : 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2012-03-16
Registration Number : 711-12-ND
Manufacturer Name : Samoh Pharmaceutical Co., Lt...
Manufacturer Address : (429-852) 63, Okgucheonseo-ro 81beon-gil, Siheung-si, Gyeonggi-do
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2014-12-03
Registration Number : Su4095-10-ND
Manufacturer Name : Siegfried Evionnaz SA
Manufacturer Address : Route du Simplon 1, 36, 1902 Evionnaz, Switzerland_x000D_
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2013-06-11
Registration Number : 1301-2-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
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, ...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
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...
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
About the Company : Anhui Haikang Pharmaceutical Co., Ltd. was established in 2009 and located in a High-tech industry park, Anqing City, Anhui Province---a famous historical and cultural city in Chin...
About the Company : DONGBANG FTL was founded in 1990 with the objective to become the most renowned and trusted company in the Active Pharmaceutical Ingredients industry through fair competition. We b...
About the Company : Hunan Warrant Pharmaceutical Co., Ltd. is a high-tech joint-stock company founded in 2001. With 3 production bases and 2 R&D center, which is engaged in manufacture & supply of API...
About the Company : Since its foundation in 1959, JEIL Pharm established. its own central research laboratory for the formulation and synthesis of drugs, followed by its successive construction of KGM...
About the Company : Founded in 1983, ST Pharm (formerly known as Samchully Pharmaceutical) has been offering excellent custom manufacturing services of APIs and their intermediates to meet clients’ ...
About the Company : Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method developmen...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.
Lead Product(s): Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: DST1308
Study Phase: UndisclosedProduct Type: Other Small Molecule
Sponsor: DRW Venture Capital LLC
Deal Size: $10.8 million Upfront Cash: Undisclosed
Deal Type: Financing January 16, 2024
Lead Product(s) : Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : DRW Venture Capital LLC
Deal Size : $10.8 million
Deal Type : Financing
DelSiTech Closes EUR 10 Million Financing Round for Drug Delivery Technology
Details : Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.
Product Name : DST1308
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 16, 2024
Details:
AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.
Lead Product(s): Imdusiran,Entecavir,Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Brand Name: AB-729
Study Phase: Phase IIProduct Type: Oligonucleotide
Sponsor: Assembly Biosciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2022
Lead Product(s) : Imdusiran,Entecavir,Vebicorvir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Assembly Biosciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.
Product Name : AB-729
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
October 24, 2022
Details:
AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus.
Lead Product(s): Imdusiran,Entecavir,Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Brand Name: AB-729
Study Phase: Phase IIProduct Type: Oligonucleotide
Sponsor: Assembly Biosciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 20, 2022
Lead Product(s) : Imdusiran,Entecavir,Vebicorvir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Assembly Biosciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to...
Product Name : AB-729
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
July 20, 2022
Details:
ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2022
Lead Product(s) : Vebicorvir,AB-729,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones
Details : ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.
Product Name : ABI-H0731
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 01, 2022
Details:
Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: BeiGene
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2021
Lead Product(s) : Vebicorvir,AB-729,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : BeiGene
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.
Product Name : ABI-H0731
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 26, 2021
Details:
Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.
Lead Product(s): Vebicorvir,Entecavir,GalNAc-RNAi
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2021
Lead Product(s) : Vebicorvir,Entecavir,GalNAc-RNAi
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.
Product Name : ABI-H0731
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 25, 2021
Details:
ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.
Lead Product(s): Vebicorvir,Entecavir,Pegylated-Interferon Alpha
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 11, 2021
Lead Product(s) : Vebicorvir,Entecavir,Pegylated-Interferon Alpha
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assembly Biosciences Abstracts Selected for Presentation at the Upcoming AASLD The Liver Meeting®
Details : ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.
Product Name : ABI-H0731
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 11, 2021
Details:
The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H2158
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 09, 2021
Lead Product(s) : ABI-H2158,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assembly Bio Announces Decision to Discontinue Clinical Development of ABI-H2158
Details : The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
Product Name : ABI-H2158
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 09, 2021
Details:
U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly’s second-generation core inhibitor, which is being evaluated in an ongoing global Phase 2 trial.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H2158
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 07, 2020
Lead Product(s) : ABI-H2158,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly’s second-generation core inhibitor, which is being evaluated in an ongoing global ...
Product Name : ABI-H2158
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 07, 2020
Details:
Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infection.
Lead Product(s): Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 28, 2020
Lead Product(s) : Vebicorvir,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clinical Data from Assembly Biosciences’ HBV Core Inhibitors Presented at The Digital Internatio...
Details : Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infect...
Product Name : ABI-H0731
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 28, 2020
CAS Number : 61717-82-6
End Use API : Entecavir
About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...
CAS Number : 88-67-5
End Use API : Entecavir
About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...
CAS Number : 61717-82-6
End Use API : Entecavir
About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...
(1S-trans)-2-[(Phenylmethoxy)methyl]-3- cyclopente...
CAS Number : 110567-21-0
End Use API : Entecavir
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
(1S,2S,3S,5S)-5-(2-Amino-6-(benzyloxy)-9H- purin-9...
CAS Number : 142217-77-4
End Use API : Entecavir
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
CAS Number : 19916-73-5
End Use API : Entecavir
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2018-03-15
Application Number : 208721
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date : 2018-03-15
Application Number : 208721
Regulatory Info : DISCN
Registration Country : USA
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Entecavir
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Entecavir
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date : 2017-08-25
Application Number : 205824
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BARACLUDE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2005-03-29
Application Number : 21797
Regulatory Info : RX
Registration Country : USA
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Excipients by Applications
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35
PharmaCompass offers a list of Entecavir 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 Entecavir manufacturer or Entecavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Entecavir manufacturer or Entecavir supplier.
PharmaCompass also assists you with knowing the Entecavir API Price utilized in the formulation of products. Entecavir API Price is not always fixed or binding as the Entecavir Price is obtained through a variety of data sources. The Entecavir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Entecavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entecavir, including repackagers and relabelers. The FDA regulates Entecavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entecavir 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 Entecavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entecavir supplier is an individual or a company that provides Entecavir active pharmaceutical ingredient (API) or Entecavir finished formulations upon request. The Entecavir suppliers may include Entecavir API manufacturers, exporters, distributors and traders.
click here to find a list of Entecavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entecavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Entecavir active pharmaceutical ingredient (API) in detail. Different forms of Entecavir DMFs exist exist since differing nations have different regulations, such as Entecavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entecavir DMF submitted to regulatory agencies in the US is known as a USDMF. Entecavir USDMF includes data on Entecavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entecavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entecavir 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 Entecavir Drug Master File in Japan (Entecavir JDMF) empowers Entecavir 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 Entecavir JDMF during the approval evaluation for pharmaceutical products. At the time of Entecavir 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 Entecavir 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 Entecavir Drug Master File in Korea (Entecavir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Entecavir. The MFDS reviews the Entecavir KDMF as part of the drug registration process and uses the information provided in the Entecavir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Entecavir 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 Entecavir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Entecavir suppliers with KDMF on PharmaCompass.
A Entecavir CEP of the European Pharmacopoeia monograph is often referred to as a Entecavir Certificate of Suitability (COS). The purpose of a Entecavir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Entecavir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Entecavir to their clients by showing that a Entecavir CEP has been issued for it. The manufacturer submits a Entecavir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Entecavir CEP holder for the record. Additionally, the data presented in the Entecavir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Entecavir DMF.
A Entecavir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Entecavir 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 Entecavir suppliers with CEP (COS) on PharmaCompass.
A Entecavir written confirmation (Entecavir WC) is an official document issued by a regulatory agency to a Entecavir manufacturer, verifying that the manufacturing facility of a Entecavir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Entecavir APIs or Entecavir finished pharmaceutical products to another nation, regulatory agencies frequently require a Entecavir WC (written confirmation) as part of the regulatory process.
click here to find a list of Entecavir 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 Entecavir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Entecavir 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 Entecavir 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 Entecavir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Entecavir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Entecavir suppliers with NDC on PharmaCompass.
Entecavir 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 Entecavir 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 Entecavir GMP manufacturer or Entecavir GMP API supplier for your needs.
A Entecavir CoA (Certificate of Analysis) is a formal document that attests to Entecavir's compliance with Entecavir specifications and serves as a tool for batch-level quality control.
Entecavir CoA mostly includes findings from lab analyses of a specific batch. For each Entecavir 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.
Entecavir may be tested according to a variety of international standards, such as European Pharmacopoeia (Entecavir EP), Entecavir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Entecavir USP).