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

71 API Suppliers, 30 USDMF, 5 JDMF, 20 EU WC, 7 KDMF, 19 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

21 Intermediates Suppliers

21 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

187 FDF Dossiers, 36 FDA Orange Book, 62 Europe, 7 Canada, 21 South Africa, 61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG, SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML), SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 6 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 2 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

99 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 50 Direct Compression, 48 Disintegrants & Superdisintegrants, 36 Thickeners and Stabilizers, 34 Granulation, 34 Controlled & Modified Release, 26 Taste Masking, 23 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 19 Solubilizers, 19 Film Formers & Plasticizers, 17 Parenteral, 13 Topical, 9 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 40 Finished Drug Prices, 8 Annual Reports

MARKET PLACE

43 APIs, 20 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical 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
28/10/2024	Neuland Laboratories	India	NEULAND LABORATORIES LTD	24506	LINEZOLID USP (FORM-II)	2010-12-29	Active	II	Complete	2014-06-27	2014-06-23
28/10/2024	Neuland Laboratories	India	NEULAND LABORATORIES LTD	36946	LINEZOLID USP (PROCESS-II)	2022-03-31	Active	II	Complete	2024-02-21	2024-01-23

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers

30 USDMF

5 JDMF

20 EU WC

7 KDMF

19 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

21 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

187 FDF Dossiers

36 FDA Orange Book

62 Europe

7 Canada

21 South Africa

61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 600MG

SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML)

SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

RELATED EXCIPIENT COMPANIES

1 Minakem

4 Rochem International Inc

17 SPI Pharma

2 Seqens

6 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

7 Faran Shimi Pharmaceutical

9 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

9 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

30 BASF

2 Clariant

12 Corel Pharma Chem

6 DFE Pharma

1 Doshion Polyscience

1 Finar

8 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

31 Kerry

5 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

25 Roquette

7 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

4 The Dow Chemical Company

2 Ulanqab Kema New Material

TABLET;ORAL - 400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons