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ACTIVE PHARMA INGREDIENTS

104 API Suppliers, 40 USDMF, 29 CEP/COS, 5 JDMF, 2 EU WC, 36 KDMF, 20 NDC API, 4 VMF, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1510 FDF Dossiers, 208 FDA Orange Book, 570 Europe, 113 Canada, 77 Australia, 157 South Africa, 385 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Rochem International Inc, 1 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 6 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 23 Controlled & Modified Release, 20 Fillers, Diluents & Binders, 19 Thickeners and Stabilizers, 12 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 9 Granulation, 9 Topical, 8 Co-Processed Excipients, 8 Direct Compression, 7 Film Formers & Plasticizers, 5 API Stability Enhancers, 5 Empty Capsules, 5 Solubilizers, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

77 News #PharmaBuzz

77 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 545 Regulatory FDF Prices, 10 Annual Reports

MARKET PLACE

104 APIs, 44 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 6 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 22 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
04/06/2025	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0121	Amoxicillin Trihydrate Ph. Eur.	2022-08-02	2025-07-02	Plot No. 68-70, 73-91, 95, 96, 260, 261, IDA, Pashamylaram (village), Patancheru (Mandal), Sangareddy District, Pincode ?502307, Telangana, India
04/06/2025	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0023	Amoxicillin Trihydrate Ph.Eur	2022-06-07	2025-06-25	Survey no. 52,53,58,59,61 to 78,127&128, Pydibhimanvaram Village &Sy.No. 1,2,4t09,11,29,30,31&32, Chittivalasa Village,Ranasthalam Mandal, Srikakulam District, AndhraPradesh, India,Pin?532409

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

104 API Suppliers

40 USDMF

29 CEP/COS

5 JDMF

2 EU WC

36 KDMF

20 NDC API

4 VMF

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1510 FDF Dossiers

208 FDA Orange Book

570 Europe

113 Canada

77 Australia

157 South Africa

385 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

TABLET;ORAL - 875MG;EQ 125MG BASE

FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

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

TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/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**

FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 400MG/5ML

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 775MG

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 Rochem International Inc

1 SPI Pharma

7 DKSH

1 Pharm-RX Chemical

1 Faran Shimi Pharmaceutical

3 Gangwal Healthcare

1 ACG Worldwide

3 Actylis

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 BASF

10 Corel Pharma Chem

3 DFE Pharma

1 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

15 Kerry

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

1 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

11 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

6 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

TABLET;ORAL - 250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 125MG BASE 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

TABLET;ORAL - 875MG 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

FOR SUSPENSION;ORAL - 200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE 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