Levodopa

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ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 21 USDMF, 12 CEP/COS, 4 JDMF, 2 EU WC, 9 KDMF, 11 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

66 Drugs in Development

66 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

734 FDF Dossiers, 134 FDA Orange Book, 513 Europe, 33 Canada, 14 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG, CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG, CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG, CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 4 Evonik, 4 Rochem International Inc, 21 SPI Pharma, 8 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 4 Kirsch Pharma, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 29 BASF, 1 CD Formulation, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 9 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 37 Direct Compression, 37 Thickeners and Stabilizers, 34 Granulation, 34 Solubilizers, 33 Controlled & Modified Release, 27 Taste Masking, 24 Parenteral, 23 Chewable & Orodispersible Aids, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 15 Topical, 15 Co-Processed Excipients, 10 Rheology Modifiers, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 99 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 128 Regulatory FDF Prices, 27 Annual Reports

MARKET PLACE

24 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

262 US Patents, 4 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 203312 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBIDOPA(UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)	CARBIDOPA ANHYDROUS	61.25mg \| 48.75mg \| 36.25mg \| 23.75mg
LEVODOPA(UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)	LEVODOPA	245mg \| 195mg \| 145mg \| 95mg

Inactive Ingredients

Ingredient Name	Amneal Pharmaceuticals LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
ETHYLCELLULOSES(7Z8S9VYZ4B)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
POVIDONE(FZ989GH94E)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TALC(7SEV7J4R1U)
TARTARIC ACID(W4888I119H)
TRIETHYL CITRATE(8Z96QXD6UM)

Setid 6c1f7cd4 De56 45c1 A734 5e77b4aeb6f7 Applno 203312 Form Capsule Extended Release Oral Dosage 61 25mg 245mg - Drug Product Composition: Levodopa

Levodopa

Levodopa

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

48 API Suppliers

21 USDMF

12 CEP/COS

4 JDMF

2 EU WC

9 KDMF

11 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

66 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

734 FDF Dossiers

134 FDA Orange Book

513 Europe

33 Canada

14 South Africa

40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

TABLET;ORAL - 12.5MG;200MG;50MG

TABLET;ORAL - 18.75MG;200MG;75MG

TABLET;ORAL - 25MG;200MG;100MG

TABLET;ORAL - 31.25MG;200MG;125MG

TABLET;ORAL - 37.5MG;200MG;150MG

TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

4 Evonik

4 Rochem International Inc

21 SPI Pharma

8 DKSH

8 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

4 Kirsch Pharma

1 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

29 BASF

1 CD Formulation

12 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

12 Gangwal Chemicals

9 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

4 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons