SUPPLIERS
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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USDMF
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41447
Submission : 2025-03-06
Status :
Type : IV
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]LISTED SUPPLIERS
FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Drug : GLYCOPYRROLATE
Dosage Form : TABLET; ORAL
Application Number : 91522
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : TIZANIDINE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 76286
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : ERRIN
Dosage Form : TABLET; ORAL-28
Application Number : 76225
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : CAPECITABINE
Dosage Form : TABLET; ORAL
Application Number : 204345
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : DIAZEPAM
Dosage Form : TABLET; ORAL
Application Number : 71136
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DROSPIRENONE; ETHINYL ESTRADIOL
Drug : DROSPIRENONE AND ETHINYL ESTRADIOL
Dosage Form : TABLET; ORAL-28
Application Number : 90081
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : DIAZEPAM
Dosage Form : TABLET; ORAL
Application Number : 71135
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
ETHINYL ESTRADIOL; LEVONORGESTREL
Drug : LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Dosage Form : TABLET; ORAL
Application Number : 78834
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : DIAZEPAM
Dosage Form : TABLET; ORAL
Application Number : 71134
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : ZIPRASIDONE HYDROCHLORIDE
Dosage Form : CAPSULE; ORAL
Application Number : 77565
Country : US
Patented : No
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Listed Dossiers
Direct Compression
Granulation
Digital Content
DATA COMPILATION #PharmaFlow
MARKET PLACE
REF. STANDARDS & IMPURITIES
