Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Dr. Reddy's Laboratories
03 1Octavius Pharma Pvt. Ltd
04 1TAPI Technology & API Services
05 1Pramukh Pharmachem
06 1Anugraha Chemicals
07 1Cadila Pharmaceuticals
08 1Cipla
09 1Darou Pakhsh Pharma Chem
10 1Gokulendu Life Science
11 1Guangzhou Tosun Pharmaceutical
12 1HELM Portugal
13 1Hikal
14 1Hoventa Pharma
15 1Ipca Laboratories
16 1Nishchem International Pvt. Ltd
17 1Qilu Pharmaceutical
18 1Sakar Healthcare
19 2Shodhana Laboratories Pvt. Ltd
20 1Sun Pharmaceutical Industries Limited
21 2Teva Pharmaceutical Industries
22 1Therapiva
01 2China
02 16India
03 1Iran
04 3Israel
05 1Portugal
06 1Spain
01 6Active
02 2Inactive
03 16Blank
01 24Blank
01 24Blank
01 1WC-0026
02 1WC-0043Amended
03 1WC-0074
04 1WC-0091
05 1WC-0094nA2A
06 1WC-0144nA2
07 1WC-0168
08 1WC-0230
09 1WC-0230A2
10 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16172
Submission : 2002-09-30
Status : Active
Type : II
NDC Package Code : 64567-0008
Start Marketing Date : 2009-08-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
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 : 16320
Submission : 2003-01-29
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043Amended
Address of the Firm :
NDC Package Code : 55111-050
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 16644
Submission : 2003-06-11
Status : Active
Type : II
Delivering high-quality, innovative solutions with regulatory excellence for the healthcare and chemical industries worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-08-06
DMF Number : 23758
Submission : 2010-08-18
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1191
Start Marketing Date : 2010-08-18
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 : 17980
Submission : 2005-01-11
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-17
Pay. Date : 2021-08-12
DMF Number : 18829
Submission : 2005-09-03
Status : Active
Type : II
Date of Issue : 2022-06-14
Valid Till : 2025-09-02
Written Confirmation Number : WC-0094nA2A
Address of the Firm :
NDC Package Code : 66651-904
Start Marketing Date : 2015-01-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2020-06-19
Registration Number : 20130510-47-B-349-18(2)
Manufacturer Name : HIKAL Ltd.
Manufacturer Address : 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-562105, Karnataka, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21027
Submission : 2007-10-29
Status : Inactive
Type : II
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19762
Submission : 2006-09-13
Status : Inactive
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-09-08
Written Confirmation Number : WC-0144nA2
Address of the Firm :
Date of Issue : 2019-10-10
Valid Till : 2022-07-02
Written Confirmation Number : WC-0230
Address of the Firm :
Date of Issue : 2020-10-12
Valid Till : 2022-07-02
Written Confirmation Number : WC-0230A2
Address of the Firm :
NDC Package Code : 51846-1033
Start Marketing Date : 2017-11-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51846-1033
Start Marketing Date : 2017-11-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-04-15
Valid Till : 2022-06-05
Written Confirmation Number : WC-0026
Address of the Firm :
A Ondansetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ondansetron, including repackagers and relabelers. The FDA regulates Ondansetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ondansetron 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 Ondansetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ondansetron supplier is an individual or a company that provides Ondansetron active pharmaceutical ingredient (API) or Ondansetron finished formulations upon request. The Ondansetron suppliers may include Ondansetron API manufacturers, exporters, distributors and traders.
click here to find a list of Ondansetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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