SUPPLIERS
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USDMF
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37309
Submission : 2022-07-12
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
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Drug : TARKA
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20591
Country : US
Patented : No
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug : VIEKIRA PAK (COPACKAGED)
Dosage Form : TABLET; ORAL
Application Number : 206619
Country : US
Patented : Yes
Drug : MAVIK
Dosage Form : TABLET; ORAL
Application Number : 20528
Country : US
Patented : No
Drug : NORVIR
Dosage Form : TABLET; ORAL
Application Number : 22417
Country : US
Patented : No
Drug : KALETRA
Dosage Form : TABLET; ORAL
Application Number : 21906
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
OMEPRAZOLE; SODIUM BICARBONATE
Drug : OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form : CAPSULE; ORAL
Application Number : 204068
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : METOPROLOL SUCCINATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 78889
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : MOXIFLOXACIN HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 76938
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : CLARITHROMYCIN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 65154
Country : US
Patented : No
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Drug : ESOMEPRAZOLE MAGNESIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 211571
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
Lubricants Glidants
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Brand Name : Sodium Stearyl Fumarate GMP
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : Lubripharm® Sodium Stearyl Fumarate (SSF) is an inert, tablet lubricant used in orally disintegrating tablets (ODTs) and effervescent formulations.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : Lubristar is used as a lubricant in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, PSD, DMF, ...
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Dosage Form : Tablet
Grade : Oral
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate (SSF) is an inert, tablet lubricant used in orally disintegrating tablets (ODTs) and effervescent formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Stearyl Fumarate
Chewable Orodispersible Aids
Disintegrants Superdisintegrants
Fillers Diluents Binders
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20 Aug 2021
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25 Oct 2018
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REF. STANDARDS & IMPURITIES
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