LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Cohance Lifesciences
03 1Jai Radhe Sales
04 1Ami Lifesciences Private Limited
05 1Aptra Synthesis
06 1Deccan Nutraceuticals Pvt. Ltd
07 1Medichem S.A
08 1Neuland Laboratories
09 3TAPI Technology & API Services
10 3Alembic Pharmaceuticals Limited
11 1Amoli Organics
12 1Apotex Pharmachem
13 1Aspire Lifesciences Pvt Ltd
14 2Atul Bioscience Ltd
15 3Aurore Life Sciences
16 1Cadila Pharmaceuticals
17 1Emcure Pharmaceuticals
18 1Guangzhou Tosun Pharmaceutical
19 1Hermes Chemical
20 1Hetero Drugs
21 1Hikal
22 1Hubei Haosun Pharmaceutical Co., Ltd.
23 1Lupin Ltd
24 2MSN Laboratories
25 1Macleods Pharmaceuticals Limited
26 1Megafine Pharma (P) Limited
27 1Nishchem International Pvt. Ltd
28 1Noucor
29 1Piramal Pharma Solutions
30 2Precise Group
31 1R L Fine Chem
32 1Senores Pharmaceuticals
33 1Shodhana Laboratories Pvt. Ltd
34 1Siegfried AG
35 1Teva Pharmaceutical Industries
36 1Viatris
37 1Wockhardt
38 1Zhejiang Apeloa Jiayuan Pharmaceutical
39 2Zydus Lifesciences
40 1Blank
01 1Canada
02 3China
03 35India
04 4Israel
05 2Spain
06 1Switzerland
07 3U.S.A
08 1Blank
01 24Active
02 4Inactive
03 22Blank
01 50Blank
01 50Blank
01 1WC-0001
02 1WC-0049
03 1WC-0054
04 1WC-0074
05 1WC-0075a3
06 1WC-0081
07 1WC-0081A3
08 1WC-0083
09 1WC-0087-(Annexure-1)
10 1WC-0119
11 1WC-0119A6
12 1WC-0119A7
13 1WC-0383A4
14 1WC-0383A8
15 36Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38066
Submission : 2023-03-03
Status : Active
Type : II
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-06-24
Registration Number : Su434-40-ND
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
Available Reg Filing : CN, MX |
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 25612
Submission : 2011-12-22
Status : Active
Type : II
NDC Package Code : 16436-0087
Start Marketing Date : 2010-06-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25747
Submission : 2012-01-30
Status : Inactive
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-05-20
Written Confirmation Number : WC-0001
Address of the Firm :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-03-17
Registration Number : 207-41-ND
Manufacturer Name : Teva API India Pvt Ltd
Manufacturer Address : Plot No. Q1~Q4, Industrial Area Ghirogi, Malanpur District - Bhind (Madhya Pradesh) India
Available Reg Filing : CA |
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 : 2013-06-06
Pay. Date : 2012-11-07
DMF Number : 25749
Submission : 2012-01-30
Status : Active
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-03-17
Registration Number : 207-41-ND
Manufacturer Name : Teva API India Pvt Ltd
Manufacturer Address : Plot No. Q1~Q4, Industrial Area Ghirogi, Malanpur District - Bhind (Madhya Pradesh) India
Available Reg Filing : CA |
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 : 2024-06-24
Pay. Date : 2024-06-17
DMF Number : 26357
Submission : 2012-08-26
Status : Active
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-03-17
Registration Number : 207-41-ND
Manufacturer Name : Teva API India Pvt Ltd
Manufacturer Address : Plot No. Q1~Q4, Industrial Area Ghirogi, Malanpur District - Bhind (Madhya Pradesh) India
Available Reg Filing : CA |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25777
Submission : 2012-02-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-02
Pay. Date : 2017-02-09
DMF Number : 30982
Submission : 2017-01-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25751
Submission : 2012-02-24
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0049
Address of the Firm :
Registrant Name : UN U-Generic Co., Ltd.
Registration Date : 2021-11-30
Registration Number : Number 827-2-ND
Manufacturer Name : Lupin Manufacturing Solutions Limited@HIKAL LIMITED
Manufacturer Address : Block No.21, Dabhasa Taluka Padra City : Dabhasa-391-440, Dist : Vadodara, Gujarat, state, India@Plot No. 72&82A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-560105, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-29
Pay. Date : 2015-07-22
DMF Number : 22691
Submission : 2009-03-27
Status : Active
Type : II
Date of Issue : 2022-06-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0083
Address of the Firm :
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2019-11-29
Registration Number : Su21-7-ND(2)
Manufacturer Name : [Starting Material 'Venlafaxine Hydrochloride' Manufacturing Plant] Alembic Pharmaceuticals Limited (API Division Panelav)@Alembic Pharmaceuticals Limited (API Division-II)
Manufacturer Address : [Starting material ‘venlafaxine hydrochloride’ manufacturing site] AT-Panelav, Tal-Halol, City: Panelav, Dist: Panchmahal, Gujarat State, India@Survey No. 144P1, 144P2, 144P3, 145P, 137, 138, 139, 140, Panelav, Tal-Halol, Dist.-Panchmahal, Gujarat state, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-31
Pay. Date : 2023-08-03
DMF Number : 38551
Submission : 2023-07-01
Status : Active
Type : II
NDC Package Code : 65977-0142
Start Marketing Date : 2014-08-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25447
Submission : 2012-02-08
Status : Active
Type : II
NDC Package Code : 65841-173
Start Marketing Date : 2018-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2019-11-26
Registration Number : Number 812-11-ND
Manufacturer Name : Cadila Pharmaceuticals Limited
Manufacturer Address : 294, GIDC Estate, City : Ankleshwar - 393 002, Dist : Bharuch Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-08
Pay. Date : 2015-03-16
DMF Number : 22472
Submission : 2009-01-22
Status : Active
Type : II
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
NDC Package Code : 65691-0067
Start Marketing Date : 2009-01-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37036
Submission : 2022-04-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-24
Pay. Date : 2023-11-17
DMF Number : 37571
Submission : 2022-11-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38001
Submission : 2023-02-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-04
Pay. Date : 2022-01-06
DMF Number : 30437
Submission : 2016-03-31
Status : Active
Type : II
Date of Issue : 2021-02-12
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A8
Address of the Firm :
NDC Package Code : 69766-008
Start Marketing Date : 2016-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-20
Pay. Date : 2017-08-28
DMF Number : 31157
Submission : 2016-11-29
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-008
Start Marketing Date : 2016-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-26
Pay. Date : 2023-08-17
DMF Number : 38624
Submission : 2023-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25656
Submission : 2012-01-13
Status : Active
Type : II
Date of Issue : 2020-10-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075a3
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-24
Pay. Date : 2022-09-27
DMF Number : 37237
Submission : 2022-07-04
Status : Active
Type : II
NDC Package Code : 14778-0606
Start Marketing Date : 2021-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34429
Submission : 2019-12-19
Status : Active
Type : II
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-11-27
DMF Number : 22372
Submission : 2008-12-27
Status : Active
Type : II
NDC Package Code : 65015-723
Start Marketing Date : 2015-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15923
Submission : 2002-04-02
Status : Inactive
Type : II
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2010-12-15
Registration Number : Su54-2-ND
Manufacturer Name : Siegfried Ltd
Manufacturer Address : Untere Bruhlstrasse 4 CH-4800 Zofingen Switzerland
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25348
Submission : 2011-10-22
Status : Inactive
Type : II
NDC Package Code : 65841-173
Start Marketing Date : 2018-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2019-11-26
Registration Number : Number 812-11-ND
Manufacturer Name : Cadila Pharmaceuticals Limited
Manufacturer Address : 294, GIDC Estate, City : Ankleshwar - 393 002, Dist : Bharuch Gujarat State, India
A Pristiq manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pristiq, including repackagers and relabelers. The FDA regulates Pristiq manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pristiq 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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A Pristiq supplier is an individual or a company that provides Pristiq active pharmaceutical ingredient (API) or Pristiq finished formulations upon request. The Pristiq suppliers may include Pristiq API manufacturers, exporters, distributors and traders.
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