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 : 39484
Submission : 2024-01-31
Status :
Type : IV
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FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : BORTEZOMIB
Dosage Form : POWDER; INTRAVENOUS
Application Number : 206927
Country : US
Patented : No
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Drug : URSODIOL
Dosage Form : TABLET; ORAL
Application Number : 213504
Country : US
Patented : No
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.
Pharmacopoeia Ref : USP, EP, BP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Tris Base
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is a buffering agent used in cell culture, downstream and biological formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Tris Base
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18 Aug 2023
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04 Sep 2020
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