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List of all Manufacturers, Suppliers & Exporters of Entecavir API listed on PharmaCompass with details of regulatory filings

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01 Century Pharmaceuticals (1)

02 Octavius Pharma Pvt. Ltd (1)

03 Viruj Pharmaceuticals Pvt Ltd (1)

04 LGM Pharma (1)

05 HRV Global Life Sciences (1)

06 Alphora Research (1)

07 Anhui HaiKang Pharmaceutical (1)

08 Apotex Pharmachem (1)

09 Aspen Biopharma Labs (1)

10 Aspire Lifesciences Pvt Ltd (1)

11 Aurobindo Pharma Limited (1)

12 BrightGene Bio-Medical Technology Co.,Ltd (1)

13 Chongqing Carelife Pharmaceutical Co., Ltd. (1)

14 Cipla (1)

15 DONG BANG FUTURE TECH & LIFE CO., LTD (1)

16 Estechpharma (2)

17 Fuxin Long Rui Pharmaceutical (1)

18 Guangzhou Tosun Pharmaceutical (1)

19 Hetero Drugs (1)

20 Hunan Warrant Chiral Pharmaceutical (1)

21 Jeil Pharmaceutical Co., Ltd (1)

22 Kyongbo Pharmaceutical Co., Ltd (1)

23 Lek Pharmaceuticals (1)

24 Lianyungang Runzhong Pharmaceutical Co Ltd (1)

25 Lunan Pharmaceutical (1)

26 ST Pharma (1)

27 ScinoPharm Taiwan, Ltd (1)

28 Shouyuan Chemical (1)

29 Sumar Biotech (1)

30 Sun Pharmaceutical Industries Limited (1)

31 Synthland (1)

32 Tecoland Corporation (1)

33 Wisdom Pharmaceutical Co., Ltd. (5)

34 Yonsung Fine Chemicals (1)

35 Yung Shin Pharmaceutical Industrial (1)

36 Zhejiang Ausun Pharmaceutical (1)

37 Zhejiang Huahai Pharmaceutical (1)

38 Zhejiang Tiantai Pharmaceutical (1)

39 Zydus Lifesciences (1)

40 Blank (1)

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01 Canada (2)

02 China (19)

03 India (12)

04 Slovenia (1)

05 South Korea (7)

06 Taiwan (1)

07 U.S.A (2)

08 Blank (1)

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01 Active (14)

02 Inactive (6)

03 Blank (25)

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01 Valid (9)

02 Blank (36)

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01 225MF10215 (1)

02 227MF10257 (1)

03 227MF10302 (1)

04 228MF10026 (1)

05 228MF10037 (1)

06 228MF10041 (1)

07 228MF10043 (1)

08 228MF10062 (1)

09 228MF10066 (1)

10 228MF10067 (1)

11 228MF10118 (1)

12 Blank (34)

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01 WC-0011 (1)

02 WC-0017 (1)

03 WC-0040 (1)

04 WC-0128 (1)

05 Blank (41)

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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Octavius Pharma

Biotechgate Digital

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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Viruj Pharmaceuticals Company banner

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Application Number
31949
R0-CEP 2018-283 - Rev 00
228MF10118
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ENTECAVIR MONOHYDRATE
Entecavir monohydrate
Entecavir intermediate (ET1) at Bui...
Issue/Submission Date
2017-08-23
2020-06-19
2016-06-24
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24601
228MF10062
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENTECAVIR HYDRATE USP, NON-STERILE ...
Entecavir hydrate at 3 Hua Nanyi Ro...
Issue/Submission Date
2011-01-28
2016-02-24
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
25200
R1-CEP 2016-152 - Rev 00
227MF10302
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ENTECAVIR MONOHYDRATE BULK DRUG SUB...
Entecavir monohydrate
Entecavir monohydrate at No. 5, Don...
Issue/Submission Date
2011-08-05
2022-06-27
2015-12-28
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USDMF

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Application Number
33490
Status
Active
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR MONOHYDRATE
Issue/Submission Date
2019-05-30
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USDMF

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Application Number
23663
R1-CEP 2016-051 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ENTECAVIR MONOHYDRATE USP
Entecavir monohydrate
Issue/Submission Date
2010-05-21
2023-01-23
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USDMF

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Application Number
32650
Status
Active
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR INTERMEDIATE
Issue/Submission Date
2018-03-27
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USDMF

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Application Number
33104
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
ENTECAVIR
Issue/Submission Date
2018-08-17
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USDMF

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Application Number
27848
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENTECAVIR USP
Issue/Submission Date
2014-01-07
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USDMF

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CEP/COS

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Application Number
27600
228MF10066
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENTECAVIR MONOHYDRATE
Entecavir hydrate at No. 1191, Sec...
Issue/Submission Date
2014-02-26
2016-02-29
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
26307
R0-CEP 2017-271 - Rev 03
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
ENTECAVIR MONOHYDRATE
Entecavir monohydrate
Entecavir (IH)/Entecavir Monohydrat...
Issue/Submission Date
2012-08-14
2023-07-28
2022-07-04
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USDMF

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Application Number
27719
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
ENTECAVIR MONOHYDRATE
Issue/Submission Date
2013-12-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
25549
CEP 2017-001 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ENTECAVIR MONOHYDRATE USP
Entecavir monohydrate
Issue/Submission Date
2011-11-30
2024-01-30
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USDMF

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Application Number
27767
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENTECAVIR USP
Issue/Submission Date
2013-12-26
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
27401
CEP 2017-043 - Rev 01
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
ENTECAVIR
Entecavir monohydrate
Entecavir (IH)/Entecavir Monohydrat...
Issue/Submission Date
2013-08-31
2023-12-06
2022-06-06
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USDMF

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Application Number
24305
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
 
Expired
2016-07-02
Filing Details
ENTECAVIR USP
Entecavir 
Issue/Submission Date
2010-10-19
2014-03-06
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USDMF

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CEP/COS

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Application Number
27444
R0-CEP 2018-006 - Rev 00
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
ENTECAVIR
Entecavir monohydrate
Issue/Submission Date
2013-11-20
2019-04-23
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USDMF

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Application Number
30446
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR INTERMEDIATE
Issue/Submission Date
2016-04-02
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USDMF

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Application Number
31248
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR INTERMEDIATE
Issue/Submission Date
2016-12-18
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USDMF

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Application Number
27066
225MF10215
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR
Entecavir hydrate at 174, Sirok-ro,...
Issue/Submission Date
2013-04-05
2013-12-03
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USDMF

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Application Number
33672
Status
Inactive
Fees Paid
N/A
 
Filing Details
ENTECAVIR NON STERILE BULK DRUG SUB...
Issue/Submission Date
2019-04-10
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USDMF

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Application Number
228MF10067
Status
 
Filing Details
Entecavir at 25, Barangongdan-ro, H...
Issue/Submission Date
2016-02-29
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USDMF

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Application Number
R0-CEP 2018-093 - Rev 00
227MF10257
Status
Valid
 
Filing Details
Entecavir monohydrate
Entecavir at 78, Jeyakgongdan 4-gil...
Issue/Submission Date
2020-04-09
2015-10-21
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USDMF

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Application Number
R0-CEP 2021-083 - Rev 00
Status
Valid
 
Filing Details
Entecavir monohydrate
Issue/Submission Date
2023-07-11
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USDMF

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Application Number
Indian CDSCO WC-0011
Status
 
Valid
2025-06-02
Filing Details
Entecavir Monohydrate (IH)
Issue/Submission Date
2022-06-08
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Application Number
228MF10041
Status
 
Filing Details
Entecavir monohydrate at 343, Sapye...
Issue/Submission Date
2016-02-08
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Looking for / Entecavir API manufacturers, exporters & distributors?

Entecavir manufacturers, exporters & distributors 1

21

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.

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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