Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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01 1Shanghai Minbiotech
02 1TAPI Technology & API Services
03 1Anax Laboratories
04 1Esteve Quimica
05 1Guangzhou Tosun Pharmaceutical
06 1Hetero Drugs
07 2MSN Laboratories
08 1TOPHARMAN SHANDONG CO LTD
09 1Tecoland Corporation
10 1Teva Pharmaceutical Industries
11 1Vannsh Life Sciences
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01 3China
02 5India
03 2Israel
04 1Spain
05 1U.S.A
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01 3Active
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01 13Blank
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01 1WC-0349
02 1WC-0349A12
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01 1No. 954-1-ND
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01 111722-079
02 154893-0096
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-27
Pay. Date : 2020-12-17
DMF Number : 35457
Submission : 2021-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37407
Submission : 2022-08-29
Status : Active
Type : II
Registrant Name : Big Think Co., Ltd.
Registration Date : 2021-10-19
Registration Number : No. 954-1-ND
Manufacturer Name : ESTEVE QUIMICA, SA@Esteve Quimica, SA
Manufacturer Address : C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain@Ctra. del Vendrell a St. Jaume dels Domenys, km. 5, 43711 Banyeres del Penedès (Tarragona), Spain
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 11722-079
Start Marketing Date : 2023-05-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
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A Neratinib Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neratinib Maleate, including repackagers and relabelers. The FDA regulates Neratinib Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neratinib Maleate 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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We have 11 companies offering Neratinib Maleate
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