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 1HRV Global Life Sciences
04 2Chromo Laboratories
05 1Dasami Lab
06 1Dipharma
07 1Emcure Pharmaceuticals
08 1Gurvey & Berry
09 1Hetero Drugs
10 1MSN Laboratories
11 1Medilux Laboratories
12 1Micro Labs Limited
13 1Optimus Pharma
14 1Prajna Generics
15 1Raks Pharma
16 1SGMR Pharmaceuticals
17 1Sekisui Medical Co. Ltd
18 1Sichuan Renan Pharmaceutical
19 1Sionc Pharmaceuticals
20 2Sunny Pharmtech
01 1Canada
02 1China
03 15India
04 1Italy
05 1Japan
06 2Taiwan
07 1U.S.A
01 10Active
02 12Blank
01 22Blank
01 22Blank
01 1WC-0273
02 1WC-0317
03 1WC-0317A2
04 1WC-0383A4
05 1WC-0578
06 17Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-16
Pay. Date : 2017-04-27
DMF Number : 31478
Submission : 2017-04-26
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-26
Pay. Date : 2021-06-10
DMF Number : 32970
Submission : 2021-06-15
Status : Active
Type : II
Date of Issue : 2024-02-19
Valid Till : 2027-02-19
Written Confirmation Number : WC-0578
Address of the Firm :
NDC Package Code : 70966-0010
Start Marketing Date : 1981-12-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-01-28
DMF Number : 33134
Submission : 2018-09-29
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 : 69766-054
Start Marketing Date : 2018-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-06
Pay. Date : 2016-04-28
DMF Number : 30439
Submission : 2016-03-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-17
Pay. Date : 2020-04-01
DMF Number : 34386
Submission : 2020-04-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-25
Pay. Date : 2018-05-07
DMF Number : 6011
Submission : 1985-08-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-15
Pay. Date : 2020-08-28
DMF Number : 35069
Submission : 2020-08-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-21
Pay. Date : 2018-12-11
DMF Number : 33407
Submission : 2018-12-19
Status : Active
Type : II
NDC Package Code : 59285-019
Start Marketing Date : 2018-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Aminocaproic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminocaproic Acid, including repackagers and relabelers. The FDA regulates Aminocaproic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminocaproic Acid 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 Aminocaproic Acid supplier is an individual or a company that provides Aminocaproic Acid active pharmaceutical ingredient (API) or Aminocaproic Acid finished formulations upon request. The Aminocaproic Acid suppliers may include Aminocaproic Acid API manufacturers, exporters, distributors and traders.
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