NCGC00024710-03

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 16 USDMF, 10 CEP/COS, 1 JDMF, 3 EU WC, 2 KDMF, 15 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers, 114 FDA Orange Book, 9 Europe, 6 Canada, 6 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Evonik, 1 Rochem International Inc, 6 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 34 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 14 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

73 Coating Systems & Additives, 63 Fillers, Diluents & Binders, 44 Disintegrants & Superdisintegrants, 42 Controlled & Modified Release, 37 Direct Compression, 37 Granulation, 35 Solubilizers, 34 Thickeners and Stabilizers, 21 Lubricants & Glidants, 21 Taste Masking, 18 Topical, 18 Parenteral, 16 Film Formers & Plasticizers, 12 Chewable & Orodispersible Aids, 11 Co-Processed Excipients, 9 Emulsifying Agents, 9 Empty Capsules, 8 Rheology Modifiers, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 18 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 18 Regulatory FDF Prices

MARKET PLACE

15 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

15 Health Canada Patents

15 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM

4 EDQM

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20943 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
verapamil hydrochloride(UNII: V3888OEY5R) (verapamil - UNII:CJ0O37KU29)	verapamil hydrochloride	100mg \| 200mg \| 300mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	Mylan Pharmaceuticals Inc.	Bryant Ranch Prepack	UCB, Inc.
AMMONIA(5138Q19F1X)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
DIETHYL PHTHALATE(UF064M00AF)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROSOFERRIC OXIDE(XM0M87F357)
fumaric acid(88XHZ13131)
GELATIN(2G86QN327L)
gelatin, unspecified(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MALTODEXTRIN(7CVR7L4A2D)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
OLEIC ACID(2UMI9U37CP)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
povidone(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
silicon dioxide(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
starch, corn(O8232NY3SJ)
SUCROSE(C151H8M554)
talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 7c822705 827f 43c7 8c27 35bc31cf6484 Applno 20943 Form Capsule Extended Release Oral Dosage 100mg - Drug Product Composition: NCGC00024710-03

NCGC00024710-03

NCGC00024710-03

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers

16 USDMF

10 CEP/COS

1 JDMF

3 EU WC

2 KDMF

15 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers

114 FDA Orange Book

9 Europe

6 Canada

6 South Africa

10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 120MG

CAPSULE, EXTENDED RELEASE;ORAL - 180MG

CAPSULE, EXTENDED RELEASE;ORAL - 240MG

CAPSULE, EXTENDED RELEASE;ORAL - 360MG

CAPSULE, EXTENDED RELEASE;ORAL - 100MG

CAPSULE, EXTENDED RELEASE;ORAL - 200MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem

6 Evonik

1 Rochem International Inc

6 SPI Pharma

11 DKSH

1 Pharm-RX Chemical

5 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

4 Kirsch Pharma

4 ACG Worldwide

10 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

34 BASF

1 Bioplus Life Sciences

1 CD Formulation

1 Clariant

16 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

14 Ideal Cures

4 Ingredion Pharma Solutions

26 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

TABLET;ORAL - 120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons