Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Cambrex Corporation
03 1Centaur Pharmaceuticals
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Osaka Synthetic Chemical Laboratories
06 1Takeda Pharmaceutical
01 2India
02 1Italy
03 2Japan
04 1U.S.A
01 3Active
02 1Inactive
03 2Blank
01 6Blank
01 1217MF10395
02 1222MF10060
03 4Blank
01 1WC-0107
02 5Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-06
Pay. Date : 2023-09-27
DMF Number : 38680
Submission : 2023-09-23
Status : Active
Type : II
NDC Package Code : 58159-096
Start Marketing Date : 2023-05-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11784
Submission : 1995-12-20
Status : Active
Type : II
NDC Package Code : 48087-0031
Start Marketing Date : 1990-12-26
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 : 12228
Submission : 1996-11-18
Status : Active
Type : II
Registration Number : 222MF10060
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2010-02-17
Latest Date of Registration : --
NDC Package Code : 12828-0077
Start Marketing Date : 2002-01-28
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 : 2859
Submission : 1977-02-10
Status : Inactive
Type : II
Registration Number : 217MF10395
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2005-08-10
Latest Date of Registration : --
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
A Esilgan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esilgan, including repackagers and relabelers. The FDA regulates Esilgan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esilgan 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 Esilgan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esilgan supplier is an individual or a company that provides Esilgan active pharmaceutical ingredient (API) or Esilgan finished formulations upon request. The Esilgan suppliers may include Esilgan API manufacturers, exporters, distributors and traders.
click here to find a list of Esilgan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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