Inke S.A: APIs manufacturing plant.
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01 2Inke S.A
02 1Transo-Pharm USA LLC
03 1LGM Pharma
04 1Transo-Pharm Handels GmbH
05 2Seqens
06 1Amino Chemicals
07 1Apicore
08 1Arene Lifesciences
09 1Ceyone Life Sciences
10 1Chemignition Laboratory
11 1Chemino Pharma
12 1Chitose Hamari
13 1Chongqing Carelife Pharmaceutical
14 1Chromo Laboratories
15 1Cipla
16 1Darou Pakhsh Pharma Chem
17 1Dolphin Pharmaceutical
18 1Fuan Pharmaceutical
19 1Grand Health Industrial Co Ltd
20 1Hamari chemicals
21 2Hana Pharm
22 1Hebei AiYoung Pharmaceutical Technology
23 1Hikma Pharmaceuticals
24 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
25 1Hubei Haosun Pharmaceutical Co., Ltd.
26 1JRC
27 1Mustafa Nevzat Ilac Sanayi A S
28 2Natco Pharma
29 1Nishchem International Pvt. Ltd
30 1OrBion Pharmaceuticals
31 1Orchid Pharma
32 1Otto Brandes
33 2Qilu Pharmaceutical
34 1ScinoPharm Taiwan Ltd
35 1Sun Pharmaceutical Industries Limited
36 1Swati Spentose
37 1Syn-Tech Chem. & Pharm
38 1Synthland
39 1Taro Pharmaceutical Industries
40 1Tecoland Corporation
41 1Wockhardt
42 1Zhejiang Hisun Pharmaceutical
43 1Blank
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01 10China
02 2France
03 2Germany
04 17India
05 1Iran
06 2Japan
07 1Malta
08 2South Korea
09 2Spain
10 2Taiwan
11 1Turkey
12 4U.S.A
13 1United Kingdom
14 1Blank
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01 15Active
02 4Inactive
03 29Blank
01 9Valid
02 3Withdrawn by Holder
03 36Blank
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01 1218MF10350
02 1218MF10399
03 1219MF10373
04 1222MF10144
05 1224MF10083
06 1225MF10063
07 1228MF10162
08 1301MF10013
09 1302MF10064
10 1305MF10130
11 1305MF10138
12 37Blank
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01 1TFDA-0002291
02 1WC-0113
03 1WC-014
04 1WC-014n
05 1WC-0165
06 43Blank
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01 120120309-177-I-41-03
02 120130314-177-I-205-02
03 120130314-177-I-205-02(1)
04 120130425-177-I-262-15
05 120130425-177-I-262-15(1)
06 120141008-177-I-437-16
07 120201008-177-I-613-17
08 41Blank
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01 114096-102
02 114778-0303
03 151916-323
04 152562-015
05 153104-7732
06 163850-7308
07 164567-0009
08 165129-1135
09 40Blank
01 48Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-10
Pay. Date : 2021-12-07
DMF Number : 17346
Submission : 2004-04-05
Status : Active
Type : II
Certificate Number : R1-CEP 2008-030 - Rev 01
Issue Date : 2016-03-17
Type : Chemical
Substance Number : 1695
Status : Valid
Registration Number : 218MF10350
Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN
Initial Date of Registration : 2006-03-17
Latest Date of Registration :
NDC Package Code : 64567-0009
Start Marketing Date : 2009-10-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2014-04-30
Registration Number : 20130314-177-I-205-02(1)
Manufacturer Name : INKE, SA
Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, SPAIN
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Date of Issue : 2022-02-22
Valid Till : 2025-07-15
Written Confirmation Number : TFDA-0002291
Address of the Firm :
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13844
Submission : 1998-11-19
Status : Active
Type : II
Certificate Number : CEP 2007-217 - Rev 05
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 1695
Status : Valid
Registration Number : 218MF10399
Registrant's Address : Ofer Park, Building E, 5th floor, 94 Shlomo Shmeltzer Road, POB 3158, Petah Tikva 4970602, Israel
Initial Date of Registration : 2006-04-14
Latest Date of Registration :
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20130425-177-I-262-15(1)
Manufacturer Name : Wavelength Enterprises LTD.
Manufacturer Address : Neot Hovav Eco-Industrial Park, POB 3593, Be'er Sheva 8413502, Israel
Available Reg Filing : ASMF |
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-03-14
Registration Number : 20130314-177-I-205-02
Manufacturer Name : INKE, SA
Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, SPAIN
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-04-25
Registration Number : 20130425-177-I-262-15
Manufacturer Name : Wavelength Enterprises Ltd.
Manufacturer Address : Neot Hovav Eco - Industrail Park, POBox 3593, Beer Sheva 8413502
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19708
Submission : 2006-08-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23588
Submission : 2010-02-25
Status : Inactive
Type : II
Registration Number : 222MF10144
Registrant's Address : 1-4-29 Shibashima, Higashiyodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2010-04-20
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16560
Submission : 2003-04-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-285 - Rev 00
Issue Date : 2013-11-18
Type : Chemical
Substance Number : 1695
Status : Withdrawn by Holder
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A GRANISOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GRANISOL, including repackagers and relabelers. The FDA regulates GRANISOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GRANISOL API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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