LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 2Cohance Lifesciences
03 3Dr. Reddy's Laboratories
04 1Jai Radhe Sales
05 1Chynops Pharma
06 1HRV Global Life Sciences
07 1Shandong Loncom Pharmaceutical
08 1SCI Pharmtech
09 1TAPI Technology & API Services
10 1Apotex Pharmachem
11 1Aspire Lifesciences Pvt Ltd
12 1Aurobindo Pharma Limited
13 1Cadila Pharmaceuticals
14 1Glenmark Life Sciences
15 1Glenmark Pharmaceuticals
16 1Guangzhou Tosun Pharmaceutical
17 2Hetero Drugs
18 2MSN Laboratories
19 1Macleods Pharmaceuticals Limited
20 1Olon S.p.A
21 1R L Fine Chem
22 1Sharon Bio-Medicine Limited
23 1Sicor Societa Italiana Corticosteroidi Srl
24 1Smilax Laboratories Limited
25 1Sun Pharmaceutical Industries Limited
26 1Syn-Tech Chem. & Pharm
27 1TATEYAMA KASEI CO LTD
28 1Teva Pharmaceutical Industries
29 1Tianish Laboratories
30 1Tivan Sciences
31 1Unichem Laboratories Limited
32 1Viatris
33 1Zhejiang Jiuzhou Pharmaceutical
34 1Zydus Lifesciences
01 1Canada
02 3China
03 26India
04 2Israel
05 2Italy
06 1Japan
07 2Taiwan
08 2U.S.A
01 15Active
02 2Inactive
03 22Blank
01 10Valid
02 29Blank
01 1229MF10113
02 1229MF10128
03 1229MF10133
04 1229MF10156
05 1303MF10088
06 1306MF10005
07 33Blank
01 1WC-0023
02 1WC-0035A3
03 1WC-0035a
04 1WC-0041
05 1WC-0062
06 1WC-0074
07 1WC-0118
08 1WC-0153
09 1WC-0168
10 1WC-0195
11 1WC-0281A3
12 1WC-0281new2
13 1WC-0390
14 26Blank
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 : Reviewed
Rev. Date : 2019-12-27
Pay. Date : 2019-12-03
DMF Number : 29211
Submission : 2015-03-26
Status : Active
Type : II
Certificate Number : CEP 2015-150 - Rev 01
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2640
Status : Valid
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1011
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN, CA |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18440
Submission : 2005-06-22
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 55111-071
Start Marketing Date : 2005-06-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-12
Pay. Date : 2020-11-09
DMF Number : 32363
Submission : 2018-06-28
Status : Active
Type : II
Certificate Number : CEP 2017-029 - Rev 04
Issue Date : 2024-12-12
Type : Chemical
Substance Number : 2640
Status : Valid
NDC Package Code : 68108-0772
Start Marketing Date : 2018-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2019-212 - Rev 02
Issue Date : 2024-07-10
Type : Chemical
Substance Number : 2640
Status : Valid
NDC Package Code : 76072-1011
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN, CA |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-15
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035A3
Address of the Firm :
NDC Package Code : 55111-071
Start Marketing Date : 2005-06-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-071
Start Marketing Date : 2005-06-22
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 : 20070
Submission : 2007-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22862
Submission : 2009-08-11
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 : 65691-0078
Start Marketing Date : 2009-08-11
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 : 20246
Submission : 2007-02-07
Status : Active
Type : II
Certificate Number : R1-CEP 2015-128 - Rev 01
Issue Date : 2022-08-29
Type : Chemical
Substance Number : 2640
Status : Valid
Registration Number : 229MF10156
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2017-08-08
Latest Date of Registration : --
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0021
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2024-05-01
Registration Number : No. 3838-3-ND(7)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-18
Pay. Date : 2019-05-09
DMF Number : 33835
Submission : 2019-05-10
Status : Active
Type : II
NDC Package Code : 66039-950
Start Marketing Date : 2019-05-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-04
Pay. Date : 2016-09-20
DMF Number : 30754
Submission : 2016-09-01
Status : Active
Type : II
Certificate Number : CEP 2017-073 - Rev 02
Issue Date : 2024-04-11
Type : Chemical
Substance Number : 2640
Status : Valid
NDC Package Code : 33342-602
Start Marketing Date : 2024-02-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-18
Pay. Date : 2023-08-03
DMF Number : 29868
Submission : 2015-10-31
Status : Active
Type : II
Certificate Number : R1-CEP 2016-025 - Rev 00
Issue Date : 2022-09-15
Type : Chemical
Substance Number : 2640
Status : Valid
Date of Issue : 2020-04-15
Valid Till : 2023-05-19
Written Confirmation Number : WC-0281new2
Address of the Firm :
NDC Package Code : 50370-0010
Start Marketing Date : 2010-04-14
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 : 19605
Submission : 2007-03-16
Status : Active
Type : II
Certificate Number : CEP 2014-241 - Rev 01
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 2640
Status : Valid
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-269
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2013-03-15
Registration Number : No. 2816-5-ND
Manufacturer Name : Apitoria Pharma Private Limited, Unit-IV
Manufacturer Address : Sy No's.52, 53, 58, 59, 61 to 78,127 & 128, Pydibhimavaram Village & Sy. No's. 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh State, India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20552
Submission : 2007-05-21
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2013-08-01
Registration Number : No. 5702-1-ND(1)
Manufacturer Name : Sun Pharmaceutical Industries Limited.
Manufacturer Address : Plot No. 24/2, 25, Phase-Ⅳ, GIDC Industrial Estate, Panoli-394 116, District Bharuch, Gujarat, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-11-29
DMF Number : 33164
Submission : 2018-09-28
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
NDC Package Code : 53747-059
Start Marketing Date : 2018-09-28
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 : 20364
Submission : 2007-03-22
Status : Active
Type : II
Certificate Number : R0-CEP 2019-236 - Rev 01
Issue Date : 2022-07-11
Type : Chemical
Substance Number : 2640
Status : Valid
Registration Number : 303MF10088
Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod
Initial Date of Registration : 2021-06-07
Latest Date of Registration : --
NDC Package Code : 65841-155
Start Marketing Date : 2018-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2016-03-30
Registration Number : No. 4749-10-ND(1)
Manufacturer Name : Cadila Pharmaceuticals Limited
Manufacturer Address : 294, GIDC Estate, City: Ankleshwar-393 002, Dist: Bharuch, India.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-07
Pay. Date : 2023-08-31
DMF Number : 19861
Submission : 2006-10-12
Status : Active
Type : II
Registration Number : 229MF10128
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2017-07-14
Latest Date of Registration : --
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-665
Start Marketing Date : 2015-03-02
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 : 20208
Submission : 2007-01-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19623
Submission : 2006-07-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-091 - Rev 01
Issue Date : 2021-03-19
Type : Chemical
Substance Number : 2640
Status : Valid
NDC Package Code : 68554-0021
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2024-05-01
Registration Number : No. 3838-3-ND(7)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0153
Address of the Firm :
Date of Issue : 2018-01-01
Valid Till : 2020-05-19
Written Confirmation Number : WC-0281A3
Address of the Firm :
NDC Package Code : 50370-0010
Start Marketing Date : 2010-04-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2013-271 - Rev 02
Issue Date : 2024-07-22
Type : Chemical
Substance Number : 2640
Status : Valid
NDC Package Code : 84206-0012
Start Marketing Date : 2024-08-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Atomoxetin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetin Hydrochloride, including repackagers and relabelers. The FDA regulates Atomoxetin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetin Hydrochloride 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 Atomoxetin Hydrochloride supplier is an individual or a company that provides Atomoxetin Hydrochloride active pharmaceutical ingredient (API) or Atomoxetin Hydrochloride finished formulations upon request. The Atomoxetin Hydrochloride suppliers may include Atomoxetin Hydrochloride API manufacturers, exporters, distributors and traders.
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