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Chemistry

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Also known as:
Molecular Formula
C12H15N5O3
Molecular Weight
277.28  g/mol
InChI Key
QDGZDCVAUDNJFG-FXQIFTODSA-N

Entecavir
1 2D Structure

Entecavir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-3H-purin-6-one
2.1.2 InChI
InChI=1S/C12H15N5O3/c1-5-6(3-18)8(19)2-7(5)17-4-14-9-10(17)15-12(13)16-11(9)20/h4,6-8,18-19H,1-3H2,(H3,13,15,16,20)/t6-,7-,8-/m0/s1
2.1.3 InChI Key
QDGZDCVAUDNJFG-FXQIFTODSA-N
2.1.4 Canonical SMILES
C=C1C(CC(C1CO)O)N2C=NC3=C2NC(=NC3=O)N
2.1.5 Isomeric SMILES
C=C1[C@H](C[C@@H]([C@H]1CO)O)N2C=NC3=C2NC(=NC3=O)N
2.2 Create Date
2005-08-01
3 Chemical and Physical Properties
Molecular Weight 277.28 g/mol
Molecular Formula C12H15N5O3
XLogP3-0.8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass277.11748936 g/mol
Monoisotopic Mass277.11748936 g/mol
Topological Polar Surface Area126 A^2
Heavy Atom Count20
Formal Charge0
Complexity480
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameBaraclude
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE 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 IngredientEntecavir
Dosage FormTablet; Solution
RouteOral
Strength0.5mg; 0.05mg/ml; 1mg
Market StatusPrescription
CompanyBristol Myers Squibb

2 of 4  
Drug NameEntecavir
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE 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 IngredientEntecavir
Dosage FormTablet
RouteOral
Strength0.5mg; 1mg
Market StatusPrescription
CompanyTeva Pharms Usa

3 of 4  
Drug NameBaraclude
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE 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 IngredientEntecavir
Dosage FormTablet; Solution
RouteOral
Strength0.5mg; 0.05mg/ml; 1mg
Market StatusPrescription
CompanyBristol Myers Squibb

4 of 4  
Drug NameEntecavir
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE 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 IngredientEntecavir
Dosage FormTablet
RouteOral
Strength0.5mg; 1mg
Market StatusPrescription
CompanyTeva Pharms Usa

API SUPPLIERS

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LGM Pharma

U.S.A

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Century Pharmaceuticals

India

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HRV Global Life Sciences

India

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Sumar Biotech

India

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Fuxin Long Rui Pharmaceutical

China

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Fuxin Long Rui Pharmaceutical

China

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Zhejiang Huahai Pharmaceutical

China

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Zhejiang Huahai Pharmaceutical

China

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Yung Shin Pharm Industrial

Taiwan

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Yung Shin Pharm Industrial

Taiwan

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Lek Pharmaceuticals

Slovenia

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Lek Pharmaceuticals

Slovenia

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Zhejiang Ausun Pharmaceutical

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Wisdom Pharmaceutical

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Wisdom Pharmaceutical

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USDMF

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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

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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

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Cipla Ltd

India

USDMF

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Cipla Ltd

India
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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

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Hetero Drugs Ltd

India

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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

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Kyongbo Pharmaceutical Co Ltd

South Korea

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27066

Submission : 2013-04-05

Status : Inactive

Type : II

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Lek Pharmaceuticals Dd

Slovenia

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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

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Scinopharm Taiwan Ltd

Taiwan

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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

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DMF Review : N/A

Rev. Date :

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DMF Number : 27444

Submission : 2013-11-20

Status : Inactive

Type : II

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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

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Certificate Number : R1-CEP 2016-051 - Rev 00

Status : Valid

Issue Date : 2023-01-23

Type : Chemical

Substance Number : 2815

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Certificate Number : CEP 2018-093 - Rev 01

Status : Valid

Issue Date : 2025-01-15

Type : Chemical

Substance Number : 2815

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Certificate Number : CEP 2017-271 - Rev 05

Status : Valid

Issue Date : 2025-05-19

Type : Chemical

Substance Number : 2815

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Certificate Number : CEP 2018-006 - Rev 01

Status : Valid

Issue Date : 2024-07-09

Type : Chemical

Substance Number : 2815

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JDMF

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Discovery Europe
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Entecavir hydrate

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

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Discovery Europe
Not Confirmed
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Entecavir Intermediate (ET1)

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

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Discovery Europe
Not Confirmed
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Entecavir hydrate

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

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Discovery Europe
Not Confirmed
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Discovery Europe
Not Confirmed

Entecavir

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

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Discovery Europe
Not Confirmed
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Entecavir monohydrate

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

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Discovery Europe
Not Confirmed
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Not Confirmed

Entecavir hydrate

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

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Discovery Europe
Not Confirmed
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Discovery Europe
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Entecavir

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

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Discovery Europe
Not Confirmed
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Entecavir

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

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Discovery Europe
Not Confirmed
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Not Confirmed

Entecavir hydrate

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

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Discovery Europe
Not Confirmed
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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

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EU WC

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Hetero Drugs

India
Discovery Europe
Not Confirmed
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Hetero Drugs

India
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Entecavir IH

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...

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Dasan Pharmaceutical

South Korea
Discovery Europe
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Dasan Pharmaceutical

South Korea
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Entecavir

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...

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Hanseo Chem

South Korea
Discovery Europe
Not Confirmed
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Hanseo Chem

South Korea
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Discovery Europe
Not Confirmed

Entecavir

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...

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Hetero Drugs

India
Discovery Europe
Not Confirmed
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Hetero Drugs

India
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Discovery Europe
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Entecavir

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,...

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Hwail Pharm Co., Ltd

South Korea
Discovery Europe
Not Confirmed
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Hwail Pharm Co., Ltd

South Korea
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Discovery Europe
Not Confirmed

Entecavir

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

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Hwail Pharm Co., Ltd

South Korea
Discovery Europe
Not Confirmed
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Hwail Pharm Co., Ltd

South Korea
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Discovery Europe
Not Confirmed

Entecavir

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

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Discovery Europe
Not Confirmed
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Entecavir

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...

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Polaris AI Pharma

South Korea
Discovery Europe
Not Confirmed
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Polaris AI Pharma

South Korea
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Discovery Europe
Not Confirmed

Entecavir

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

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SamoFarm

Uzbekistan
Discovery Europe
Not Confirmed
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SamoFarm

Uzbekistan
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Discovery Europe
Not Confirmed

Entecavir

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

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Siegfried AG

Switzerland
Discovery Europe
Not Confirmed
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Siegfried AG

Switzerland
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Discovery Europe
Not Confirmed

Entecavir

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_

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ST Pharma

South Korea
Discovery Europe
Not Confirmed
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ST Pharma

South Korea
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Discovery Europe
Not Confirmed

Entecavir

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

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Listed Suppliers

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01

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Digital Content Digital Content

Entecavir

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, ...

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, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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02

  • fda
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  • WHO-GMP

Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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Entecavir

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...

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 India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.
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03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Entecavir

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...

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 offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.

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Entecavir

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...

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 experienced research scientists and manufacturing professionals. We work together to innovate and manufacture semi-synthetic, synthetic, and fermentation-based APIs. Our R&D facility is equipped with state-of-the-art technology for synthesis, extraction, isolation, and purification of products from the upstream (fermentation) process. Our team is also involved in developing and implementing new ideas in process chemistry for various therapeutic molecules.
Sumar Biotech

05

Discovery Europe
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Discovery Europe
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Entecavir

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...

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 China, adjacent to SINOPEC Anqing Branch. This industry park has been declared as a national chemical industry park, providing a strong impetus and solid guarantee for the future development of us. As a production base, Anhui Haikang provides sufficient high-quality pharmaceutical and chemical products.
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06

Discovery Europe
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Discovery Europe
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Entecavir

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...

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 believe that providing people with quality-assured pharmaceutical products is one of the most effective ways to contribute towards 'happiness and health of humanity' and hence have been trying our utmost best to achieve our goal.
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07

Discovery Europe
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Discovery Europe
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Entecavir

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...

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 APIs and Intermediates, Solid Dosage Formulations, Herbal Extracts, most of the APIs and all formulation production lines are new GMP certified. Hunan Warrant Chiral Pharmaceutical Co., Ltd. belongs to Hunan Warrant Parmaceutical Co., located in Ltd. & occupies more than 70 000 square meters, Tongguan Circuliar Economy Industrial Park in Wangcheng. It is a CFDA approved pharmaceutical company, focusing on the APIs & advanced intermediates manufacturing in China.
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08

Discovery Europe
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Discovery Europe
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Entecavir

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...

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 KGMP factory in 1986. JEIL's fine chemical production facilities are entirely controlled by the BGMP according to the GMP guideline for bulk chemical production related to general, special, and aseptic pharmaceuticals.On the other hands, JEIL is manufacturing FDF Products sold to Japan and other countries.With marketing strategy of 'First generic' and Innovative drug, JEIL have been extended the market in world-wide.
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09

ST Pharma

South Korea
Discovery Europe
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ST Pharma

South Korea
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Discovery Europe
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Entecavir

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’ ...

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’ high expectation for their use in pharmaceutical development and be compliant to cGMP requirements. Our reliability in service, which is well-proven through decades of business relationship with many big pharmas and biotech clients, is the essence of our strength along with our expertise in process development and scale-up optimization.
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10

Discovery Europe
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Discovery Europe
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Entecavir

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...

Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method development. Tecoland provides high quality APIs to the pharmaceutical industry, with reliable technical and regulatory support such as USDMF, CEP, EDMF that are critical to the speedy approval of our customers’ regulatory filings.
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05-Feb-2022
01-May-2025
KGS
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Drugs in Development

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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

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01

DelSiTech

Finland
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Discovery Europe
Not Confirmed

DelSiTech

Finland
arrow
Discovery Europe
Not Confirmed

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

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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

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02

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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03

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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04

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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05

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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06

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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07

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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09

Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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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

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Discovery Europe
Not Confirmed
Discovery Europe
Not Confirmed

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

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INTERMEDIATE SUPPLIERS

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01

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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 ...

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02

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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 ...

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03

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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 ...

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04

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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...

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05

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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...

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06

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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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...

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07

LinkChem

China
Specialty & Agro Chemical
Not Confirmed
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LinkChem

China
Specialty & Agro Chemical
Not Confirmed
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CAS Number : 10310-21-1

End Use API : Entecavir

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Entecavir

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Entecavir

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

03

ENTECAVIR

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

Breckenridge Pharmaceutical

04

ENTECAVIR

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

Breckenridge Pharmaceutical

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Entecavir

Brand Name : Entecavir

Dosage Form : Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Entecavir

Brand Name : Entecavir

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

07

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Entecavir

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

08

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Entecavir

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

09

Accord healthcare

United Kingdom
Specialty & Agro Chemical
Not Confirmed
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Accord healthcare

United Kingdom
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Specialty & Agro Chemical
Not Confirmed

ENTECAVIR

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

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10

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

ENTECAVIR

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

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 21797

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DOSAGE - TABLET;ORAL - 1MG

USFDA APPLICATION NUMBER - 21797

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DOSAGE - SOLUTION;ORAL - 0.05MG/ML

USFDA APPLICATION NUMBER - 21798

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ABOUT THIS PAGE

Looking for / Entecavir API manufacturers, exporters & distributors?

Entecavir manufacturers, exporters & distributors 1

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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.

API | Excipient name

Entecavir

Entecavir Manufacturers

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.

Entecavir Suppliers

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.

Entecavir USDMF

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.

Entecavir JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The 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.

Entecavir KDMF

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.

Entecavir CEP

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.

Entecavir WC

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.

Entecavir NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Entecavir as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Entecavir API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 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.

Compounded drug products

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 GMP

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.

Entecavir CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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