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List of Drug Master Files (DMF) of Potassium hydrogen carbonate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Potassium Hydrogen Carbonate
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Potassium hydrogen carbonate

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ACTIVE PHARMA INGREDIENTS

4 API Suppliers, 1 USDMF, 3 Listed Suppliers

4 API Suppliers
1 USDMF
3 Listed Suppliers

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

16 FDF Dossiers, 12 Europe, 2 Canada, 2 Listed Dossiers

16 FDF Dossiers
12 Europe
2 Canada
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 1 DKSH, 1 Pharm-RX Chemical, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Actylis, 1 Aeon Procare, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Bioplus Life Sciences, 2 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 5 Kerry, 10 Microlex e.U, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 27 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

1 Evonik
5 Rochem International Inc
19 SPI Pharma
1 DKSH
1 Pharm-RX Chemical
8 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 Actylis
1 Aeon Procare
2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
1 Bioplus Life Sciences
2 DFE Pharma
4 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
5 Kerry
10 Microlex e.U
1 Pharmatrans-Sanaq
5 Pluviaendo
2 Prachin Chemical
27 Roquette
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
9 Sigachi Industries
2 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 24 Direct Compression, 22 Taste Masking, 15 Chewable & Orodispersible Aids, 13 Thickeners and Stabilizers, 13 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Film Formers & Plasticizers, 11 Granulation, 7 Coating Systems & Additives, 7 Parenteral, 5 Disintegrants & Superdisintegrants, 5 Controlled & Modified Release, 2 Solubilizers, 1 API Stability Enhancers, 1 Soft Gelatin, 1 Topical, 1 Rheology Modifiers, 1 Emulsifying Agents

46 Fillers, Diluents & Binders
24 Direct Compression
22 Taste Masking
15 Chewable & Orodispersible Aids
13 Thickeners and Stabilizers
13 Lubricants & Glidants
11 Co-Processed Excipients
11 Film Formers & Plasticizers
11 Granulation
7 Coating Systems & Additives
7 Parenteral
5 Disintegrants & Superdisintegrants
5 Controlled & Modified Release
2 Solubilizers
1 API Stability Enhancers
1 Soft Gelatin
1 Topical
1 Rheology Modifiers
1 Emulsifying Agents

GLOBAL SALES INFORMATION

10 Finished Drug Prices

10 Finished Drug Prices

MARKET PLACE

3 APIs, 1 EXCIPIENTS

3 APIs
1 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

1 USP
1 Others

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API Suppliers
USDMF
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Heico Chemicals Div Whittaker Corp

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USDMF

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Heico Chemicals Div Whittaker Corp

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Potassium Bicarbonate, Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6403

Submission : 1986-06-02

Status : Inactive

Type : II

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