GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33081
Submission : 2018-08-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33609
Submission : 2019-02-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33625
Submission : 2019-02-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33656
Submission : 2019-03-13
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33751
Submission : 2019-04-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33804
Submission : 2019-04-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33848
Submission : 2019-05-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34087
Submission : 2019-08-19
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20915
Submission : 2007-09-25
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-097 - Rev 01
Issue Date : 2020-12-04
Type : Chemical
Substance Number : 316
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27016
Submission : 2013-03-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33625
Submission : 2019-02-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33804
Submission : 2019-04-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33609
Submission : 2019-02-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33751
Submission : 2019-04-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34087
Submission : 2019-08-19
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33081
Submission : 2018-08-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33656
Submission : 2019-03-13
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33848
Submission : 2019-05-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 449
Submission : 1961-09-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6600
Submission : 1986-09-23
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Microlose™ M60 P60
Application : Direct Compression
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 440 g/l, Bulk density- 310 g/l; Particl...
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Excipient Details : HiCel acts as a strong & dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlose™ M60 P60
Application : Co-Processed Excipients
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Microcrystalline Cellulose
Application : Co-Processed Excipients
Excipient Details : Direct Compression
Pharmacopoeia Ref : NF/EP/JP
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Co-Processed Excipients
Excipient Details : Standard Direct Tabletting Or Roller Compaction
Pharmacopoeia Ref : NF/EP/JP
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Disintequik™ MCC 25
Application : Co-Processed Excipients
Excipient Details : Direct Tabletting Operations Where Fast Disintegration Is Required
Pharmacopoeia Ref : NF/EP/JP
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
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