DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

6 API Suppliers, 6 USDMF, 3 NDC API

6 API Suppliers
6 USDMF
3 NDC API

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
2 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

31 US Patents, 6 US Exclusivities

patents
31 US Patents
6 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: N-ethyl-1-[3-(trifluoromethyl)phenyl]propan-2-amine; hydron; chloride, Akos015890422, A821256, A825124

Molecular Formula

C₁₂H₁₇ClF₃N

Molecular Weight

267.72 g/mol

InChI Key

ZXKXJHAOUFHNAS-UHFFFAOYSA-N

1 2D Structure

Fenfluramine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-ethyl-1-[3-(trifluoromethyl)phenyl]propan-2-amine;hydron;chloride

2.1.2 InChI

InChI=1S/C12H16F3N.ClH/c1-3-16-9(2)7-10-5-4-6-11(8-10)12(13,14)15;/h4-6,8-9,16H,3,7H2,1-2H3;1H

2.1.3 InChI Key

ZXKXJHAOUFHNAS-UHFFFAOYSA-N

2.1.4 Canonical SMILES

[H+].CCNC(C)CC1=CC(=CC=C1)C(F)(F)F.[Cl-]

2.2 Synonyms

2.2.1 Depositor-Supplied Synonyms

1. N-ethyl-1-[3-(trifluoromethyl)phenyl]propan-2-amine; Hydron; Chloride

2. Akos015890422

3. A821256

4. A825124

2.3 Create Date

2010-05-19

3 Chemical and Physical Properties

Molecular Formula	C₁₂H₁₇ClF₃N
Molecular Weight	267.72 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	4
Exact Mass	267.1001617 g/mol
Monoisotopic Mass	267.1001617 g/mol
Topological Polar Surface Area	12 Å²
Heavy Atom Count	17
Formal Charge	0
Complexity	203
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

Virtual Booth

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

02

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

03

Olon S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

04

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

05

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

06

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Biophore India Pharmaceuticals Pvt L...

India

Medlab Asia & Asia Health

Not Confirmed

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

India

Virtual Booth

Digital Content

Fenfluramine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37321

Submission : 2022-07-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Country

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

01

Biophore India Pharmaceuticals Pvt....

India

Medlab Asia & Asia Health

Not Confirmed

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

India

Virtual Booth

Digital Content

FENFLURAMINE HYDROCHLORIDE

NDC Package Code : 73435-023

Start Marketing Date : 2023-12-20

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

02

Maithri Drugs Private Limited

India

Medlab Asia & Asia Health

Not Confirmed

03

Olon SpA

Italy

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

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FDF Dossiers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

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Digital Content

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

DMF submissions in 2020: Industry sustains its filing momentum

In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant surprise. During the first half of this year, the industry maintained its momentum of filing DMFs with the FDA. In the first six months of this year, FDA received 283 DMF submissions (against 616 for the full year of 2019). Expectedly, India continued to lead with 155 DMF filings. Submissions from India were more than double the amount of those made by Chinese (45) and American firms (30) combined. This trend has been witnessed for some time now. In 2019, out of the 616 active DMF submissions to the FDA, Indian companies had submitted more than half (331), though the submissions from India were a little less than double of those made by Chinese and American firms. Drug master files (DMFs) are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drug products.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads total count of DMF filings As in the past, India’s MSN Laboratories continued to lead the DMF filings by a single company with 40 submissions, followed by Dr Reddy’s (8) and Metrochem API (7). MSN has always been a pioneer in being the first to file a DMF for new products. This year was no different. The firm submitted the first DMF for 11 products — Abaloparatide, Abemaciclib, Amifampridine Phosphate, Betrixaban Maleate, Fenfluramine Hydrochloride, Lofexidine Hydrochloride, Neratinib Maleate, Ozenoxacin, Rolapitant Hydrochloride, Tafamidis, Valbenazine Tosylate. There were also first DMF filings by AMRI (Brexanolone), Formosa Laboratories (Elagolix Sodium), Glenmark Life Sciences (Solriamfetol Hydrochloride) and Hikal (Ertugliflozin L-Pyroglutamic Acid). The API DMF is part of the final generic drug product submission to the FDA. Therefore, the owner of a DMF incurs a one-time fee, the first time the generic drug submission references that DMF. DMF holders may also pay the fee in advance in order to have their DMF subjected to an initial completeness assessment by the FDA. This would allow their DMF to be included on a publicly available list of DMFs that have paid their fee and have not failed the initial completeness assessment. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Assessment review of only 62 DMFs completed by the FDA While 283 DMFs were submitted to the FDA, only 22 percent of them — or 62 DMFs — have had their assessment review completed by the FDA so far. The GDUFA fee associated with a DMF assessment review for the current fiscal year is US$ 57,795. It has been revised upward to US$ 69,921 (an increase of US$ 12,126) for the upcoming fiscal year, which starts in October. Although MSN led in the number of DMF filings, it had no assessments completed for its DMF submissions in the first half of the year. Three Indian companies, Aurobindo, Honour Lab and Intas, and one Chinese company, Jiangsu Hengrui, led in the maximum (three each) number of assessments completed by the FDA. The products with the most commonly filed DMFs were Brivaracetam, Cetrorelix, Edaravone and Lifitegrast, with four submissions each. DMF filings also help provide insights into some of the new drug approvals that can be expected in the future. In the first half of the year, we witnessed submissions for Dapoxetine Hydrochloride (MSN), Fasoracetam (MSN), Indoximod (MSN), Resiniferatoxin (Indena), Omidenepag Isopropyl (UBE Industries), Treosulphan (Fermion), Roxadustat (Dr Reddy’s), Bexagliflozin (Piramal), Antazoline Phosphate (Metrochem) and Dyphylline (Shanghai Wonder) which are all products that have currently not been approved by the FDA and could potentially be approved in the future.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Our view The Covid crisis and the surging demand for APIs like hydroxychloroquine, favipiravir and dexamethasone has revealed the global dependence on India and China for APIs. India, a prominent API manufacturer, admitted to its extreme dependence on China for APIs and intermediates when it shared a list of products which included antibiotics, vitamins, hormones and even commonly used medicines like aspirin and paracetamol. In July this year, India announced the guidelines for its schemes for the development of bulk drugs and medical device parks across the country. These schemes are part of India’s self-reliance campaign. Similar reshoring initiatives have been announced by the United States, France and Japan, and many other countries also want to reduce their reliance on China. While shifting supply chains is certainly a long drawn out process, the wheels have definitely started to turn. It remains to be seen what impact these initiatives will have on the DMF filings with the FDA in the next few quarters. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)