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List of Drug Master Files (DMF) of (+)-Methadone hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Methadone Hydrochloride
(+)-Methadone Hydrochloride
Esmethadone Hydrochloride
CAS 125-79-1
CAS 86-29-3
Normethadone
Methadone
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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Methadone Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 10 USDMF, 8 CEP/COS, 1 JDMF, 6 EU WC, 11 NDC API, 12 Listed Suppliers, $ API Reference Price

26 API Suppliers
10 USDMF
8 CEP/COS
1 JDMF
6 EU WC
11 NDC API
12 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, FDF Exports

API Reference Price
API Exports
FDF Exports

FINISHED DOSAGE FORMULATIONS

149 FDF Dossiers, 51 FDA Orange Book, 57 Europe, 18 Canada, 6 South Africa, 17 Listed Dossiers

149 FDF Dossiers
51 FDA Orange Book
57 Europe
18 Canada
6 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CONCENTRATE;ORAL - 10MG/ML, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CONCENTRATE;ORAL - 10MG/ML
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 11 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 9 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 25 Kerry, 12 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 24 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

1 Rochem International Inc
6 SPI Pharma
1 DKSH
11 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
1 Pfanstiehl
9 Actylis
1 Aeon Procare
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
6 BASF
5 DFE Pharma
2 Finar
7 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
2 Ingredion Pharma Solutions
25 Kerry
12 Microlex e.U
2 Nanjing Bold Chemical
1 Pharmatrans-Sanaq
4 Pluviaendo
2 Prachin Chemical
24 Roquette
1 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
1 Valens Pharmachem
2 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 29 Direct Compression, 19 Thickeners and Stabilizers, 17 Lubricants & Glidants, 15 Film Formers & Plasticizers, 15 Co-Processed Excipients, 14 Parenteral, 13 Granulation, 11 Taste Masking, 11 Coating Systems & Additives, 9 Topical, 9 Controlled & Modified Release, 9 Disintegrants & Superdisintegrants, 8 Chewable & Orodispersible Aids, 6 Solubilizers, 5 Emulsifying Agents, 1 API Stability Enhancers, 1 Soft Gelatin, 1 Rheology Modifiers

61 Fillers, Diluents & Binders
29 Direct Compression
19 Thickeners and Stabilizers
17 Lubricants & Glidants
15 Film Formers & Plasticizers
15 Co-Processed Excipients
14 Parenteral
13 Granulation
11 Taste Masking
11 Coating Systems & Additives
9 Topical
9 Controlled & Modified Release
9 Disintegrants & Superdisintegrants
8 Chewable & Orodispersible Aids
6 Solubilizers
5 Emulsifying Agents
1 API Stability Enhancers
1 Soft Gelatin
1 Rheology Modifiers

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

16 Finished Drug Prices

16 Finished Drug Prices

MARKET PLACE

7 APIs, 2 FDF Dossiers

7 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

3 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 2,003 Xls

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01 1AMIDONE, DOLPHINE (4,4-DIPHENYL-6-DIMETHYLAMINO-3-HEPTANONE HCL)

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Univ Minnesota

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Univ Minnesota

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Amidone, Dolphine (4,4-diphenyl-6-dimethylamin...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36

Submission : 1947-04-17

Status : Inactive

Type : II

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