Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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CAFFEINE ANHYDROUS

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 10 USDMF, 9 CEP/COS, 11 JDMF, 1 KDMF, 18 NDC API, 24 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

369 FDF Dossiers, 126 FDA Orange Book, 15 Europe, 24 Canada, 129 South Africa, 75 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 356.4MG;30MG;16MG, TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 100MG;1MG, TABLET;ORAL - 325MG;50MG;40MG, SUPPOSITORY;RECTAL - 100MG;2MG, TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 14 Rochem International Inc, 30 SPI Pharma, 2 Seqens, 26 DKSH, 3 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 1 ICE Pharma, 16 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 21 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 46 BASF, 1 Bioplus Life Sciences, 4 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 15 Gangwal Chemicals, 1 Hayashibara, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 26 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 46 Roquette, 20 Seppic, 3 Shandong Focus Biotechnology Co., Ltd, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

128 Fillers, Diluents & Binders, 66 Coating Systems & Additives, 63 Thickeners and Stabilizers, 56 Topical, 55 Solubilizers, 54 Direct Compression, 46 Disintegrants & Superdisintegrants, 44 Taste Masking, 37 Controlled & Modified Release, 37 Parenteral, 37 Granulation, 31 Film Formers & Plasticizers, 28 Lubricants & Glidants, 25 Co-Processed Excipients, 24 Emulsifying Agents, 24 Chewable & Orodispersible Aids, 18 Surfactant & Foaming Agents, 14 API Stability Enhancers, 12 Rheology Modifiers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

32 NEWS #PharmaBuzz

32 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices

MARKET PLACE

78 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 2 JP, 5 Others

ANALYTICAL

1 BioAnalytical Methods, 13 Analytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/11/2024	Boehringer Ingelheim GmbH	Germany	BOEHRINGER INGELHEIM PHARMA KG	5753	CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES	1954-03-27	Inactive	II	N/A
28/11/2024	CSPC New Nova Pharmaceutical	China	CSPC INNOVATION PHARM CO LTD	21002	Caffeine	2007-11-02	Active	II	N/A

CAFFEINE ANHYDROUS

CAFFEINE ANHYDROUS

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers

10 USDMF

9 CEP/COS

11 JDMF

1 KDMF

18 NDC API

24 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

369 FDF Dossiers

126 FDA Orange Book

15 Europe

24 Canada

129 South Africa

75 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 356.4MG;30MG;16MG

TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 100MG;1MG

TABLET;ORAL - 325MG;50MG;40MG

SUPPOSITORY;RECTAL - 100MG;2MG

TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

14 Rochem International Inc

30 SPI Pharma

2 Seqens

26 DKSH

3 Pharm-RX Chemical

10 Faran Shimi Pharmaceutical

9 Boai NKY Pharmaceuticals Ltd

16 Gangwal Healthcare

1 ICE Pharma

16 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Capital Farma

4 ACG Worldwide

21 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

46 BASF

1 Bioplus Life Sciences

4 Clariant

13 Corel Pharma Chem

7 DFE Pharma

3 Finar

15 Gangwal Chemicals

1 Hayashibara

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

5 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

26 Microlex e.U

1 Nanjing Bold Chemical

2 Nippon Fine Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

12 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

TABLET;ORAL - 325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons