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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01 1Nuray Chemicals Private Limited
02 1Ami Lifesciences Private Limited
03 1Macsen Labs
04 1Albemarle Corporation
05 1Alkem Laboratories
06 1Aspire Lifesciences Pvt Ltd
07 1Catalent Pharma Solutions
08 1Formosa Laboratories
09 1Grace
10 1KINGLAND CHEMICALS CO LTD
11 1Novartis Pharmaceuticals Corporation
12 1Siegfried AG
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01 1China
02 5India
03 2Switzerland
04 1Taiwan
05 3U.S.A
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01 4Active
02 3Inactive
03 5Blank
01 12Blank
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01 12Blank
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01 1WC-0054
02 11Blank
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01 120220503-209-J-1282
02 11Blank
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01 158159-114
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-114
Start Marketing Date : 2024-11-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39002
Submission : 2023-12-04
Status : Active
Type : II
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 7843
Submission : 1988-12-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-06
Pay. Date : 2013-05-23
DMF Number : 5196
Submission : 1983-12-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-03
Pay. Date : 2013-05-03
DMF Number : 21703
Submission : 2008-06-16
Status : Active
Type : II
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-05-03
Registration Number : 20220503-209-J-1282
Manufacturer Name : Formosa Laboratories, Inc.
Manufacturer Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24194
Submission : 2010-09-20
Status : Inactive
Type : II
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 : 12421
Submission : 1997-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12327
Submission : 1997-01-21
Status : Inactive
Type : II
89
PharmaCompass offers a list of Benzonatate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Benzonatate manufacturer or Benzonatate supplier for your needs.
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A Tessalon Perles manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tessalon Perles, including repackagers and relabelers. The FDA regulates Tessalon Perles manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tessalon Perles 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 Tessalon Perles supplier is an individual or a company that provides Tessalon Perles active pharmaceutical ingredient (API) or Tessalon Perles finished formulations upon request. The Tessalon Perles suppliers may include Tessalon Perles API manufacturers, exporters, distributors and traders.
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We have 12 companies offering Tessalon Perles
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