Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 1HRV Global Life Sciences
06 1Medichem S.A
07 1Shandong Loncom Pharmaceutical
08 1Alembic Pharmaceuticals Limited
09 1Alven Laboratories
10 1Aspire Lifesciences Pvt Ltd
11 1Aurobindo Pharma Limited
12 1Guangzhou Tosun Pharmaceutical
13 2Johnson & Johnson Innovative Medicine
14 1Kimia Biosciences
15 1MSN Laboratories
16 1Shilpa Medicare
17 1Shouyuan Chemical
18 1Sun Pharmaceutical Industries Limited
19 1Symed Labs
20 1Torrent Pharmaceuticals Limited
01 3China
02 1Czech Republic
03 13India
04 1Spain
05 3U.S.A
01 10Active
02 2Inactive
03 9Blank
01 21Blank
01 21Blank
01 1WC-0147
02 1WC-0349
03 1WC-0382
04 1WC-0416
05 1WC-0474
06 1WC-0493
07 15Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-28
DMF Number : 37576
Submission : 2022-10-31
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-06
Pay. Date : 2022-09-19
DMF Number : 34970
Submission : 2020-08-21
Status : Active
Type : II
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-011
Start Marketing Date : 2020-06-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-04
Pay. Date : 2023-04-17
DMF Number : 36765
Submission : 2022-02-18
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-083
Start Marketing Date : 2021-06-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-03
Pay. Date : 2022-06-13
DMF Number : 37181
Submission : 2022-06-13
Status : Active
Type : II
NDC Package Code : 16436-0129
Start Marketing Date : 2022-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-12
Pay. Date : 2023-07-26
DMF Number : 34862
Submission : 2020-09-25
Status : Active
Type : II
Date of Issue : 2019-12-02
Valid Till : 2022-08-08
Written Confirmation Number : WC-0382
Address of the Firm :
NDC Package Code : 66022-0207
Start Marketing Date : 2018-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-19
Pay. Date : 2022-09-09
DMF Number : 37301
Submission : 2022-08-30
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0123
Start Marketing Date : 2022-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-14
Pay. Date : 2023-06-06
DMF Number : 38084
Submission : 2023-06-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-21
Pay. Date : 2023-09-25
DMF Number : 38893
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-24
Pay. Date : 2023-08-11
DMF Number : 37911
Submission : 2023-08-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-14
Pay. Date : 2020-08-13
DMF Number : 35038
Submission : 2020-08-28
Status : Active
Type : II
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147
Address of the Firm :
NDC Package Code : 82920-042
Start Marketing Date : 2022-10-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2019-05-28
Registration Number : Su469-1-ND
Manufacturer Name : Shilpa Pharma Lifesciences Limited
Manufacturer Address : Raichur Industrial Growth Centre, Plot Nos. 33, 33A, 40 to 47, Block C,D,E,H,I & AM, Chicksugur - 584 134, Dist: Raichur. Karnataka, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11649
Submission : 1995-09-12
Status : Inactive
Type : II
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2012-10-26
Registration Number : Su217-15-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Janssen Pharmaceuticalaan 3 B-2440 Geel Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12826
Submission : 1998-01-20
Status : Inactive
Type : II
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2012-10-26
Registration Number : Su217-15-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Janssen Pharmaceuticalaan 3 B-2440 Geel Belgium
Date of Issue : 2020-06-18
Valid Till : 2023-06-17
Written Confirmation Number : WC-0474
Address of the Firm :
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2019-11-13
Registration Number : Su331-18-ND
Manufacturer Name : Alven Laboratories sro
Manufacturer Address : Holická 1173/49a, Hodolany, 779 00 Olomouc, Czech Republic
A Prucalopride Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prucalopride Succinate, including repackagers and relabelers. The FDA regulates Prucalopride Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prucalopride Succinate 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 Prucalopride Succinate supplier is an individual or a company that provides Prucalopride Succinate active pharmaceutical ingredient (API) or Prucalopride Succinate finished formulations upon request. The Prucalopride Succinate suppliers may include Prucalopride Succinate API manufacturers, exporters, distributors and traders.
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