Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Sanofi
03 1LGM Pharma
04 1Jai Radhe Sales
05 1Octavius Pharma Pvt. Ltd
06 1Atman Pharmaceuticals
07 1Bal Pharma
08 2TAPI Technology & API Services
09 2Abbott Laboratories
10 1Alembic Pharmaceuticals Limited
11 2Amoli Organics
12 1Arevipharma
13 1AstraZeneca
14 2Aurobindo Pharma Limited
15 1Blue Circle Organics
16 1CTX Lifesciences
17 1Cambrex Corporation
18 1Cerata Pharmaceuticals
19 2Changzhou Pharmaceutical Factory
20 1DEAFARMA
21 1Daiichi Sankyo
22 1Flamma SpA
23 2GSK
24 1Harman Finochem
25 1Hexahub Pharmachem
26 1Industriale Chimica
27 1Integrin Life Sciences
28 3Ipca Laboratories
29 1JRC
30 1Macleods Pharmaceuticals Limited
31 1Medimpex
32 1Medinex Laboratories
33 1Nishchem International Pvt. Ltd
34 1Otto Brandes
35 1Pliva Hrvatska
36 1Posh Chemicals P. Ltd
37 1Qingdao Qingmei Biotech
38 1Shreeneel Chemicals
39 1Southwest Synthetic Pharmaceutical
40 1Suzhou Lixin Pharmaceutical
41 1Teva Pharmaceutical Industries
42 1Titan Laboratories
43 3Unichem Laboratories Limited
44 1Unipex
45 1Zhejiang Huahai Pharmaceutical
46 1Zhuhai Rundu Pharmaceutical
47 1Zydus Lifesciences
48 2Blank
01 7China
02 1Croatia
03 2France
04 2Germany
05 29India
06 3Israel
07 3Italy
08 1Japan
09 1Poland
10 4U.S.A
11 4United Kingdom
12 2Blank
01 17Active
02 14Inactive
03 28Blank
01 4Expired
02 19Valid
03 1Withdrawn by Holder
04 35Blank
01 1218MF11020
02 1219MF10334
03 1224MF10171
04 1224MF10214
05 1225MF10021
06 1229MF10218
07 53Blank
01 1WC-0017
02 1WC-0063
03 1WC-0077
04 1WC-0077A3
05 1WC-0081
06 1WC-0084
07 1WC-0091
08 1WC-0097
09 1WC-0279
10 1WC-0468
11 49Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-06
Pay. Date : 2014-12-29
DMF Number : 17599
Submission : 2004-08-12
Status : Active
Type : II
Certificate Number : CEP 2004-058 - Rev 06
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 218MF11020
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2006-12-28
Latest Date of Registration : --
NDC Package Code : 12658-0405
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-05-04
Registration Number : 20180611-209-J-86(3)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CN, CA |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5125
Submission : 1983-11-07
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 2115
Submission : 1973-06-14
Status : Active
Type : II
Certificate Number : R1-CEP 2001-304 - Rev 12
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 394
Status : Valid
Available Reg Filing : ASMF |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 4028
Submission : 1980-12-10
Status : Active
Type : II
Certificate Number : R1-CEP 2004-149 - Rev 07
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 394
Status : Valid
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-31
Pay. Date : 2019-07-11
DMF Number : 33923
Submission : 2019-06-29
Status : Active
Type : II
Certificate Number : CEP 2021-088 - Rev 00
Issue Date : 2024-01-23
Type : Chemical
Substance Number : 394
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19721
Submission : 2006-08-31
Status : Active
Type : II
Certificate Number : R0-CEP 2004-233 - Rev 01
Issue Date : 2013-11-29
Type : Chemical
Substance Number : 394
Status : Expired
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-30
Pay. Date : 2013-04-23
DMF Number : 16278
Submission : 2002-11-26
Status : Active
Type : II
Certificate Number : CEP 2000-091 - Rev 07
Issue Date : 2024-11-05
Type : Chemical
Substance Number : 394
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-008
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-209-J-347
Manufacturer Name : Unichem Laboratories Ltd
Manufacturer Address : Plot No. 99, MIDC Area, Dhatav, Roha Raigad 402 116 Maharashtra State India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-14
Pay. Date : 2013-09-06
DMF Number : 20534
Submission : 2007-04-18
Status : Active
Type : II
NDC Package Code : 53747-008
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-209-J-347
Manufacturer Name : Unichem Laboratories Ltd
Manufacturer Address : Plot No. 99, MIDC Area, Dhatav, Roha Raigad 402 116 Maharashtra State India
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-12-05
DMF Number : 16707
Submission : 2003-07-07
Status : Active
Type : II
Certificate Number : R1-CEP 2004-013 - Rev 06
Issue Date : 2023-08-29
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 224MF10171
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India
Initial Date of Registration : 2012-08-16
Latest Date of Registration : --
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1127
Start Marketing Date : 2012-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-862
Manufacturer Name : IPCA Laboratories Limited
Manufacturer Address : Sejavta Dist. Ratlam(MP)PIN. 457 002 India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-31
Pay. Date : 2013-07-17
DMF Number : 18563
Submission : 2005-11-11
Status : Active
Type : II
Certificate Number : CEP 2012-044 - Rev 02
Issue Date : 2023-09-26
Type : Chemical
Substance Number : 394
Status : Valid
NDC Package Code : 57451-1127
Start Marketing Date : 2012-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-862
Manufacturer Name : IPCA Laboratories Limited
Manufacturer Address : Sejavta Dist. Ratlam(MP)PIN. 457 002 India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2012-11-23
DMF Number : 22541
Submission : 2008-01-31
Status : Active
Type : II
Certificate Number : CEP 2009-060 - Rev 02
Issue Date : 2023-11-14
Type : Chemical
Substance Number : 394
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22027
Submission : 2008-09-24
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm :
NDC Package Code : 65841-162
Start Marketing Date : 2024-09-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-14
DMF Number : 21039
Submission : 2007-11-04
Status : Active
Type : II
Certificate Number : R1-CEP 2008-021 - Rev 05
Issue Date : 2023-08-29
Type : Chemical
Substance Number : 394
Status : Valid
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
NDC Package Code : 42419-001
Start Marketing Date : 2007-11-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20190213-209-J-188(1)
Manufacturer Name : CTX Life Sciences Pvt. Limited.
Manufacturer Address : Block No. 251/P, 252/P, 253 to 255, 256/P, 258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P, GIDC, City : Sachin Magdalla Road, Dist : Surat, 394230 Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-17
DMF Number : 17728
Submission : 2004-09-24
Status : Active
Type : II
Certificate Number : CEP 2005-013 - Rev 06
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 224MF10214
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2012-11-08
Latest Date of Registration : --
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-323
Start Marketing Date : 2023-12-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-27
DMF Number : 16750
Submission : 2003-08-08
Status : Active
Type : II
NDC Package Code : 55488-0300
Start Marketing Date : 1984-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2021-06-15
Registration Number : 20201027-209-J-474(1)
Manufacturer Name : Changzhou Pharmaceutical Factory
Manufacturer Address : No.518 East Laodong Road, Changzhou, City China
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-11
DMF Number : 881
Submission : 1965-01-02
Status : Active
Type : II
Certificate Number : CEP 2004-307 - Rev 07
Issue Date : 2024-02-23
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 219MF10334
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2007-11-20
Latest Date of Registration : --
NDC Package Code : 12828-0008
Start Marketing Date : 1986-01-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-03
Registration Number : 20210503-209-J-683
Manufacturer Name : Cambrex Profarmaco Milano Srl
Manufacturer Address : Via Curiel, 34 – 20067 Paullo (Milano) Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4436
Submission : 1982-02-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5614
Submission : 1984-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2492
Submission : 1975-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28206
Submission : 2014-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21181
Submission : 2007-12-31
Status : Inactive
Type : II
Certificate Number : CEP 2012-250 - Rev 02
Issue Date : 2023-09-20
Type : Chemical
Substance Number : 394
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15991
Submission : 2002-05-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 456
Submission : 1961-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6237
Submission : 1985-06-10
Status : Inactive
Type : II
Certificate Number : CEP 2020-017 - Rev 01
Issue Date : 2024-11-12
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 225MF10021
Registrant's Address : Unichem Bhavan, Prabhat Estate, S. V. Road, Jogeshwari (West), Mumbai-400 102, India
Initial Date of Registration : 2013-02-06
Latest Date of Registration : --
Date of Issue : 2023-05-22
Valid Till : 2026-03-30
Written Confirmation Number : WC-0468
Address of the Firm :
NDC Package Code : 53747-008
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-209-J-347
Manufacturer Name : Unichem Laboratories Ltd
Manufacturer Address : Plot No. 99, MIDC Area, Dhatav, Roha Raigad 402 116 Maharashtra State India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4924
Submission : 1983-04-29
Status : Inactive
Type : II
Certificate Number : CEP 2006-011 - Rev 04
Issue Date : 2023-09-05
Type : Chemical
Substance Number : 394
Status : Valid
NDC Package Code : 55488-0300
Start Marketing Date : 1984-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2021-06-15
Registration Number : 20201027-209-J-474(1)
Manufacturer Name : Changzhou Pharmaceutical Factory
Manufacturer Address : No.518 East Laodong Road, Changzhou, City China
A Hydrochlorothiazide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrochlorothiazide, including repackagers and relabelers. The FDA regulates Hydrochlorothiazide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrochlorothiazide 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 Hydrochlorothiazide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrochlorothiazide supplier is an individual or a company that provides Hydrochlorothiazide active pharmaceutical ingredient (API) or Hydrochlorothiazide finished formulations upon request. The Hydrochlorothiazide suppliers may include Hydrochlorothiazide API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrochlorothiazide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 47 companies offering Hydrochlorothiazide
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