Clarithromycin

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ACTIVE PHARMA INGREDIENTS

66 API Suppliers, 23 USDMF, 20 CEP/COS, 16 JDMF, 6 EU WC, 59 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

499 FDF Dossiers, 50 FDA Orange Book, 234 Europe, 26 Canada, 8 Australia, 38 South Africa, 143 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML, FOR SUSPENSION;ORAL - 250MG/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 9 SPI Pharma, 2 Seqens, 13 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 28 BASF, 2 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 15 Microlex e.U, 3 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 74 Coating Systems & Additives, 41 Controlled & Modified Release, 38 Solubilizers, 37 Direct Compression, 36 Thickeners and Stabilizers, 34 Disintegrants & Superdisintegrants, 27 Topical, 26 Lubricants & Glidants, 25 Granulation, 22 Parenteral, 21 Film Formers & Plasticizers, 19 Co-Processed Excipients, 15 Taste Masking, 14 Emulsifying Agents, 11 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

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2 DATA COMPILATION #PharmaFlow, 27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 211 Finished Drug Prices

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40 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

57 Health Canada Patents

57 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 USP, 10 Others

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USFDA APPLICATION NUMBER - 50698 / DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLARITHROMYCIN(UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)	CLARITHROMYCIN	250mg in 5 \| 125mg in 5 \| 500mg \| 500mg \| 250mg

Inactive Ingredients

Ingredient Name	Zydus Pharmaceuticals USA Inc	AbbVie Inc.	A-S Medication Solutions
CARBOMER 1342(809Y72KV36)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(809Y72KV36)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(HHT01ZNK31)
CASTOR OIL(D5340Y2I9G)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM SORBATE(1VPU26JZZ4)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SORBIC ACID(X045WJ989B)
SORBITAN MONOOLEATE(06XEA2VD56)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
VANILLIN(CHI530446X)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Clarithromycin

Clarithromycin

Clarithromycin

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ACTIVE PHARMA INGREDIENTS

66 API Suppliers

23 USDMF

20 CEP/COS

16 JDMF

6 EU WC

59 KDMF

12 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

20 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

499 FDF Dossiers

50 FDA Orange Book

234 Europe

26 Canada

8 Australia

38 South Africa

143 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML

FOR SUSPENSION;ORAL - 250MG/5ML

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

9 SPI Pharma

2 Seqens

13 DKSH

3 Jai Radhe Sales

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

9 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

28 BASF

2 Clariant

14 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

12 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

34 Kerry

3 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

15 Microlex e.U

3 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

6 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons