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

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Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking

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ACTIVE PHARMA INGREDIENTS

117 API Suppliers, 80 USDMF, 22 CEP/COS, 16 JDMF, 7 EU WC, 109 KDMF, 106 NDC API, 32 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

2562 FDF Dossiers, 730 FDA Orange Book, 503 Europe, 290 Canada, 75 Australia, 402 South Africa, 562 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 1 Evonik, 14 Rochem International Inc, 31 SPI Pharma, 2 Seqens, 32 DKSH, 3 Pharm-RX Chemical, 11 Faran Shimi Pharmaceutical, 14 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 18 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 13 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

144 Fillers, Diluents & Binders, 81 Thickeners and Stabilizers, 71 Solubilizers, 69 Coating Systems & Additives, 61 Direct Compression, 60 Taste Masking, 54 Topical, 49 Disintegrants & Superdisintegrants, 45 Parenteral, 40 Controlled & Modified Release, 40 Lubricants & Glidants, 40 Film Formers & Plasticizers, 40 Granulation, 27 Chewable & Orodispersible Aids, 26 Emulsifying Agents, 25 Co-Processed Excipients, 18 Rheology Modifiers, 15 Surfactant & Foaming Agents, 13 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

13 DATA COMPILATION #PharmaFlow, 342 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 406 Finished Drug Prices, 20 Annual Reports

MARKET PLACE

179 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 7 USP, 1 JP, 26 Others

ANALYTICAL

2 BioAnalytical Methods, 8 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	Granules India Limited	India	GRANULES INDIA LTD	17722	COMPRESSO PAP 90 CPF	2004-09-22	Active	II	N/A
28/11/2024	IOL Chemicals and Pharmaceuticals	India	IOL CHEMICALS AND PHARMACEUTICALS LTD	37336	ACETAMINOPHEN USP (PARACETAMOL USP)	2022-07-28	Active	II	N/A

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

117 API Suppliers

80 USDMF

22 CEP/COS

16 JDMF

7 EU WC

109 KDMF

106 NDC API

32 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

2562 FDF Dossiers

730 FDA Orange Book

503 Europe

290 Canada

75 Australia

402 South Africa

562 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

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

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET;ORAL - 325MG;37.5MG

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

TABLET;ORAL - 325MG;5MG

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

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 Minakem

1 Evonik

14 Rochem International Inc

31 SPI Pharma

2 Seqens

32 DKSH

3 Pharm-RX Chemical

11 Faran Shimi Pharmaceutical

14 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

18 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Capital Farma

4 ACG Worldwide

19 Actylis

3 Aeon Procare

4 Alcedo Pharmachem

12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

4 Finar

17 Gangwal Chemicals

2 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

5 Kima Chemical

6 Lonza Capsugel

27 Microlex e.U

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons