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

2 API Suppliers, 2 USDMF, 2 KDMF, 1 Listed Suppliers

2 API Suppliers
2 USDMF
2 KDMF
1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

4 FDF Dossiers, 1 FDA Orange Book, 1 Canada, 2 South Africa

4 FDF Dossiers
1 FDA Orange Book
1 Canada
2 South Africa

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1 DATA COMPILATION #PharmaFlow

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1 DATA COMPILATION #PharmaFlow

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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

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FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

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)

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0EXCIPIENTS BY APPLICATIONS

Chemistry

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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

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Shanghai Wonder Pharmaceutical

China

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

Ethiodized Oil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37450

Submission : 2022-08-30

Status : Active

Type : II

02

Shanghai Wonder Pharmaceutical Co Lt...

China

Medlab Asia & Asia Health

Not Confirmed

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KDMF

01

SHANGHAI ZHONGXI SUNVE PHARMACEUTIC...

China

Medlab Asia & Asia Health

Not Confirmed

02

SHANGHAI ZHONGXI SUNVE PHARMACEUTIC...

China

Medlab Asia & Asia Health

Not Confirmed

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

Listed Suppliers

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

Ethiodized Oil

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

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

FDF Dossiers

01

AXIM

South Africa

Medlab Asia & Asia Health

Not Confirmed

02

GUERBET

France

Medlab Asia & Asia Health

Not Confirmed

03

GUERBET

France

Medlab Asia & Asia Health

Not Confirmed

04

GUERBET

France

Medlab Asia & Asia Health

Not Confirmed

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FDA Orange Book

01

GUERBET

France

Medlab Asia & Asia Health

Not Confirmed

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Canada

01

GUERBET

France

Medlab Asia & Asia Health

Not Confirmed

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South Africa

01

Axim Pharmaceuticals (Pty) Ltd

South Africa

Medlab Asia & Asia Health

Not Confirmed

02

Guerbet South Africa (Pty) Ltd

France

Medlab Asia & Asia Health

Not Confirmed

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

Digital Content

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DATA COMPILATION #PharmaFlow

FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder). Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period. Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.