Cohance Lifesciences DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Corporate Presentation

GMP Certificate 2024

FDF Product List 2024

API Product List 2024

Intermediate Product List 2024

Pellet Product List 2024

Antibody-Drug Conjugate Brochure 2024

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DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 6088

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 2816

NEWS #PharmaBuzz

Suven, Cohance to Double Business Revenue to Rs 6,000 Cr by FY29

01 Nov 2024

// ECONOMICTIMES

Cohance Lifesciences merger with Suven Pharma gets NSE, BSE nod

27 Jul 2024

// TIMESOFINDIA

Suven, with Cohance and more, wants to become a CDMO powerhouse

02 Mar 2024

// ECONOMIC TIMES

Suven-Cohance Lifesciences merger announced

29 Feb 2024

// PRESS RELEASE

Advent Launches New Brand For Its API Platform

04 Jan 2023

// PRESS RELEASE

Advent launches Cohance Lifesciences, a new brand identity for its API platform

01 Nov 2022

// PRESS RELEASE

ALL APIs

01

Rivaroxaban

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

Click Us!

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF CN

AUDIT

02

Aripiprazole

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF Others AUDIT

03

Atomoxetin Hydrochloride

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF CN, CA

AUDIT

04

Dipyridamole

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF CN, RU, ...

AUDIT

05

Doxazosin Mesylate

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF CN, RU

AUDIT

06

Entacapone

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF CN

AUDIT

07

Fluvoxamine

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF Others AUDIT

08

Itraconazole

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF MX, APAC

AUDIT

09

Lamotrigine

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF CN

AUDIT

10

Midazolam

India

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

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF Others AUDIT

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USDMF

01

(s)-8-ethyl-8-hydroxy-2,3,5,8-tetrah...

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39042

Submission : 2023-10-20

Status : Active

Type : II

02

1-acetamido 3,5-dimethyl Adamantane

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33684

Submission : 2019-03-29

Status : Active

Type : II

Product
Web Link

03

7-ethyl-10-hydroxycamptothecin

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39031

Submission : 2024-09-09

Status : Active

Type : II

04

Apixaban

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34988

Submission : 2020-07-02

Status : Active

Type : II

05

Aripiprazole Usp

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-16

Pay. Date : 2017-10-18

DMF Number : 30120

Submission : 2015-12-14

Status : Active

Type : II

06

Atomoxetine Hydrochloride Usp

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2019-12-27

Pay. Date : 2019-12-03

DMF Number : 29211

Submission : 2015-03-26

Status : Active

Type : II

07

Baclofen Usp

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2018-12-29

Pay. Date : 2018-11-26

DMF Number : 33302

Submission : 2018-11-09

Status : Active

Type : II

08

Clozapine Usp

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2019-01-29

Pay. Date : 2018-12-07

DMF Number : 31999

Submission : 2017-08-24

Status : Active

Type : II

09

D-threo Ritalinic Acid Hydrochloride

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27931

Submission : 2014-01-21

Status : Active

Type : II

Product
Web Link

10

Dapagliflozin Propanediol Monohydrat...

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34235

Submission : 2019-10-15

Status : Active

Type : II

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

01

4-ETHYL-4-HYDROXY-7,8-DIHYDRO-1H-PYRANO(3,4-F)INDOLIZINE-3,6,10(4H)-TRIONE, (S)-

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 70772-0005

Start Marketing Date : 2024-05-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

02

7-AMINOMETHYL-10,11-METHYLENEDIOXYCAMPTOTHECIN

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 70772-0003

Start Marketing Date : 2024-01-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

03

7-ETHYL-10-HYDROXYCAMPTOTHECIN

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 70772-0001

Start Marketing Date : 2018-01-11

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

04

APIXABAN

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1017

Start Marketing Date : 2019-07-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

05

ARIPIPRAZOLE

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1002

Start Marketing Date : 2016-04-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

06

ATOMOXETINE HYDROCHLORIDE

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1011

Start Marketing Date : 2017-06-05

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

07

BETAHISTINE HYDROCHLORIDE

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1001

Start Marketing Date : 2015-03-20

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

08

CLOZAPINE

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1010

Start Marketing Date : 2017-06-05

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

09

DAPAGLIFLOZIN PROPANEDIOL

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1014

Start Marketing Date : 2019-07-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

10

DAPSONE

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

NDC Package Code : 76072-1018

Start Marketing Date : 2019-07-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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LISTED APIs

01

Aripiprazole

India

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Stock Recap
#Pipeline Prospector

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Drugs in Development

01 Cohance Lifesciences

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Lead Product(s) : Favipiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

DEALS_DEV

Avra Laboratories Gets Regulatory Approval for Covid-19 Drug Favipiravir

Details : Ciplenza (favipiravir-generic) is a RNA-directed RNA polymerase inhibitor, small molecule, which is indicated for the treatment of patients with Covid-19 infection.

Brand Name : Ciplenza

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 27, 2020

Data Compilation
#PharmaFlow

Virtual Booth

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FDF Dossiers

01

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

04

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

05

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

06

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

07

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Aspirin; Dipyridamole

Dosage Form :

Dosage Strength : 25MG; 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

08

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

09

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

10

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Listed Dossiers

01

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

04

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

05

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

06

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Dosage Form : Oral Dispersible Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

07

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Aspirin; Dipyridamole

Dosage Form :

Dosage Strength : 25MG; 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

08

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

09

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

10

Brand Name : N/A

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Regulatory Info :

Registration Country : India

Baclofen

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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ALL Intermediates

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KEY PRODUCTS

TOP RANKED SUPPLIER FOR:

Services

Discover the service capabilities from this company

Clinical Trials

Discover their expertise for :

Early Clinical / Phase I-IIa

01

PHASE IB & IIA CLINICAL STUDIES

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : Clinical Trials

Cohance Lifesciences, through its CRBio division, offers clinical trial solutions to its partners by carrying out BA and BE studies including Phase 1b, 2a clinical trials.

Category : Early Clinical / Phase I-IIa

Sub Category : Phase I / IIa

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : Clinical Trials

PHASE IB & IIA CLINICAL STUDIES

Cohance Lifesciences, through its CRBio division, offers clinical trial solutions to its partners by carrying out BA and BE studies including Phase 1b, 2a clinical trials.

Service
Web Link

Capabilities
#ServicesBio

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Clinical Development / Phase IIb-IV

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API Manufacturing

Discover their expertise for :

Scale Up

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Clinical Supply

01

API CLINICAL SUPPLY

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

Cohance Lifesciences is a contract development and manufacturing organization (CDMO), offering custom manufacturing services for APIs from pre-clinical to all the phases of clinical trials.

Category : Clinical Supply

Sub Category : Overview

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

API CLINICAL SUPPLY

Cohance Lifesciences is a contract development and manufacturing organization (CDMO), offering custom manufacturing services for APIs from pre-clinical to all the phases of clinical trials.

Service
Web Link

Capabilities
#ServicesBio

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Small Molecules

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Small Scale Batch

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Controlled Substance

01

CONTROLLED SUBSTANCE API MANUFAC...

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

Cohance Lifesciences has comprehensive contract manufacturing facilities for the production of complex active pharmaceutical ingredients including controlled substances and highly potent APIs (HPAPIs).

Category : Controlled Substance

Sub Category : Overview

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

CONTROLLED SUBSTANCE API MANUFACTURING

Service
Web Link

Capabilities
#ServicesBio