GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37745
Submission : 2022-11-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37656
Submission : 2022-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23613
Submission : 2010-03-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37199
Submission : 2022-06-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17763
Submission : 2004-09-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17995
Submission : 2004-12-30
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-222 - Rev 00
Issue Date : 2006-08-01
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2001-001 - Rev 01
Issue Date : 2008-05-16
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2000-278 - Rev 00
Issue Date : 2006-04-02
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2000-269 - Rev 00
Issue Date : 2006-02-13
Type : TSE
Substance Number : 1474
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37199
Submission : 2022-06-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17763
Submission : 2004-09-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17995
Submission : 2004-12-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37745
Submission : 2022-11-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23613
Submission : 2010-03-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37656
Submission : 2022-11-05
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-269 - Rev 00
Status : Valid
Issue Date : 2006-02-13
Type : TSE
Substance Number : 1474
Stearic Acid, Industrene® 8718
Certificate Number : R1-CEP 2001-004 - Rev 00
Status : Valid
Issue Date : 2006-10-17
Type : TSE
Substance Number : 1474
Certificate Number : R1-CEP 2001-003 - Rev 00
Status : Valid
Issue Date : 2006-10-17
Type : TSE
Substance Number : 1474
Certificate Number : R1-CEP 2001-002 - Rev 00
Status : Valid
Issue Date : 2006-10-17
Type : TSE
Substance Number : 1474
Stearic Acid, Industrene® 7018
Certificate Number : R1-CEP 2001-009 - Rev 00
Status : Valid
Issue Date : 2006-12-14
Type : TSE
Substance Number : 1474
Stearic Acid, Emersol® 6320, 6332 And 6349
Certificate Number : R1-CEP 2001-101 - Rev 01
Status : Valid
Issue Date : 2009-08-31
Type : TSE
Substance Number : 1474
Stearic Acid, Code Number 2216
Certificate Number : R1-CEP 2000-222 - Rev 00
Status : Valid
Issue Date : 2006-08-01
Type : TSE
Substance Number : 1474
Certificate Number : R1-CEP 2001-001 - Rev 01
Status : Valid
Issue Date : 2008-05-16
Type : TSE
Substance Number : 1474
Certificate Number : R1-CEP 2000-278 - Rev 00
Status : Valid
Issue Date : 2006-04-02
Type : TSE
Substance Number : 1474
Certificate Number : R1-CEP 2000-389 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-03-03
Type : TSE
Substance Number : 1474
Stearic Acid (BP/Ph. Eur./USP-NF)
Date of Issue : 2020-02-24
Valid Till : 2022-07-02
Written Confirmation Number : WC-0187
Address of the Firm : Plot No.133, S. V. Co-Op. Indl. Estate, Bollaram, Medak Dist, AP
FINISHED DOSAGE FORMULATIONS
STEARIC ACID
Route : BUCCAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : BUCCAL/SUBLINGUAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 6
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : IMPLANTATION
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 0.2
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 52
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 3
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 3
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 3.23
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 15
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 21
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57114
UNII : 4ELV7Z65AP
Potency Amount : 1203
Potency Unit : MG/5ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Coating Systems & Additives
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Coating Systems & Additives
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Application : Coating Systems & Additives
Excipient Details : Ready mix Film coating system for moisture sensitive APIs
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Moisture barrier film coating system
Ingredient(s) : Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Coating Systems & Additives
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Application : Film Formers & Plasticizers
Excipient Details : Ready mix Film coating system for moisture sensitive APIs
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Moisture barrier film coating system
Ingredient(s) : Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Application : Lubricants & Glidants
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Application : Lubricants & Glidants
Excipient Details : Stearic acid is a saturated, wax-like, fatty acid commonly used in the production of pharmaceutical tablets and capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Capsule, Granule / Pellet, Suppository, Tablet
Grade : Not Available
Category : Lubricants & Glidants
Application : Lubricants & Glidants
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Application : Fillers, Diluents & Binders
Excipient Details : Stearic acid is a saturated, wax-like, fatty acid commonly used in the production of pharmaceutical tablets and capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Application : Topical
Excipient Details : Structure-building consistency factor with dry feel, forms crystalline barrier on skin
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP: Stearic ...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Softgel Capsule
Grade : Not Available
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : Structure-building consistency factor with dry feel, forms crystalline barrier on skin
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP: Stearic ...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
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