Lifecare Labs has been developing innovative products in specialist areas of medicine.
01 1Lifecare Laboratories Pvt Ltd
02 1ALP Pharm
03 1Hunan Huateng Pharmaceutical Co ltd
04 1Kyowa Kirin
05 1Kyowa Pharma Chemical Co Ltd
06 1MSN Laboratories
07 1OUCHI SHINKO CHEMICAL INDUSTRIAL
08 1Procos
09 1TATEYAMA KASEI CO LTD
10 1Zhejiang Ausun Pharmaceutical
11 1Blank
01 3China
02 2India
03 1Italy
04 4Japan
05 1Blank
01 3Active
02 1Inactive
03 7Blank
01 11Blank
01 1229MF10036
02 1303MF10109
03 1303MF10119
04 8Blank
01 11Blank
Lifecare Labs has been developing innovative products in specialist areas of medicine.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38212
Submission : 2023-04-12
Status : Active
Type : II
NDC Package Code : 46016-1550
Start Marketing Date : 2022-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40030
Submission : 2024-07-09
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38721
Submission : 2023-09-29
Status : Active
Type : II
NDC Package Code : 72640-026
Start Marketing Date : 2023-09-29
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 : 23936
Submission : 2010-07-01
Status : Inactive
Type : II
Registration Number : 303MF10119
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2021-07-28
Latest Date of Registration : --
Registration Number : 303MF10109
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2021-07-16
Latest Date of Registration : --
A Istradefylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Istradefylline, including repackagers and relabelers. The FDA regulates Istradefylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Istradefylline 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 Istradefylline supplier is an individual or a company that provides Istradefylline active pharmaceutical ingredient (API) or Istradefylline finished formulations upon request. The Istradefylline suppliers may include Istradefylline API manufacturers, exporters, distributors and traders.
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