LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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02 1TAPI Technology & API Services
03 1Alembic Pharmaceuticals Limited
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01 1WC-0041
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01 1Su2807-4-ND
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01 146708-895
02 154893-0054
03 162756-050
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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 : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
Status : Active
Type : II
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0107
Start Marketing Date : 2013-07-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II

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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 42832
Submission : 2025-10-22
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-17
Pay. Date : 2017-03-24
DMF Number : 31285
Submission : 2016-12-31
Status : Active
Type : II
Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0054
Start Marketing Date : 2016-12-31
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2022-08-08
Registration Number : Su674-3-ND(1)
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-II), Sy.No.50, Kardanur (village), Patti (Post), Patancheru (Mandal), Sangareddy District, Pincode-502 300. Telangana State, India.

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
NDC Package Code : 62756-050
Start Marketing Date : 2025-12-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II

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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, and more, enabling you to easily find the right Afatinib manufacturer or Afatinib supplier for your needs.
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A Afatinib dimaleate (USAN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afatinib dimaleate (USAN), including repackagers and relabelers. The FDA regulates Afatinib dimaleate (USAN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afatinib dimaleate (USAN) 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 (USAN) supplier is an individual or a company that provides Afatinib dimaleate (USAN) active pharmaceutical ingredient (API) or Afatinib dimaleate (USAN) finished formulations upon request. The Afatinib dimaleate (USAN) suppliers may include Afatinib dimaleate (USAN) API manufacturers, exporters, distributors and traders.
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We have 29 companies offering Afatinib dimaleate (USAN)
Get in contact with the supplier of your choice: