SUPPLIERS
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USDMF
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35501
Submission : 2021-02-05
Status :
Type : IV
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Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Certificate Number : R0-CEP 2021-327 - Rev 00
Status : Valid
Issue Date : 2022-04-13
Type : Chemical
Substance Number : 685
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FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
Drug : NAMENDA XR
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 22525
Country : US
Patented : Yes
Drug : KADIAN
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20616
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : TAMOXIFEN CITRATE
Dosage Form : TABLET; ORAL
Application Number : 75797
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : VALGANCICLOVIR HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 206876
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : AMIODARONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 75389
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : FILM; BUCCAL, SUBLINGUAL
Application Number : 205806
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : FILM; BUCCAL, SUBLINGUAL
Application Number : 205299
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : VALGANCICLOVIR HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 203511
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
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
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Solubilizers
Co Processed Excipients
API Stability Enhancers
Lubricants Glidants
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DATA COMPILATION #PharmaFlow
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