LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1TAPI Technology & API Services
03 2Alembic Pharmaceuticals Limited
04 1Artis Biotech
05 1Aurore Life Sciences
06 1Beijing Sjar Technology Development
07 1Biotechnica DWC
08 1Epoch Labs
09 1Fresenius Kabi Oncology Limited
10 1Guangzhou Tosun Pharmaceutical
11 1Hangzhou Longshine Bio-Tech
12 2Hetero Drugs
13 1MSN Laboratories
14 1Mac-Chem Products (India) Pvt.Ltd
15 1Natco Pharma
16 1Ningbo Zhenlei Chemical Co.,Ltd
17 1Qilu Antibiotics Pharmaceutical Co., Ltd.
18 1Sakar Healthcare
19 1Shilpa Medicare
20 1Shouyuan Chemical
21 1Sicor de Mexico
22 1Sun Pharmaceutical Industries Limited
23 1Teva Pharmaceutical Industries
24 1Vannsh Life Sciences
25 1Wuhan Wuyao Pharmaceutical
26 1Yangtze River Pharmaceutical Group
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01 1Algeria
02 8China
03 15India
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06 1U.S.A
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01 1WC-0041
02 1WC-0041A3
03 1WC-0082
04 1WC-0082A8
05 1WC-0115A3
06 1WC-0349
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01 146708-895
02 154893-0054
03 163592-0355
04 168554-0107
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 2017-07-18
Pay. Date : 2017-06-27
DMF Number : 31848
Submission : 2017-06-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
NDC Package Code : 46708-895
Start Marketing Date : 2017-06-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-21
Pay. Date : 2019-02-12
DMF Number : 33080
Submission : 2019-02-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-29
Pay. Date : 2017-04-28
DMF Number : 31515
Submission : 2017-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
Date of Issue : 2021-04-20
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A8
Address of the Firm :
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PharmaCompass offers a list of Afatinib 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 Afatinib manufacturer or Afatinib supplier for your needs.
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A Afatinib (diMaleate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afatinib (diMaleate), including repackagers and relabelers. The FDA regulates Afatinib (diMaleate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afatinib (diMaleate) 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 Afatinib (diMaleate) supplier is an individual or a company that provides Afatinib (diMaleate) active pharmaceutical ingredient (API) or Afatinib (diMaleate) finished formulations upon request. The Afatinib (diMaleate) suppliers may include Afatinib (diMaleate) API manufacturers, exporters, distributors and traders.
click here to find a list of Afatinib (diMaleate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 26 companies offering Afatinib (diMaleate)
Get in contact with the supplier of your choice: