Syngene International Ltd. is a worldwide discovery, development, and manufacturing organization that offers comprehensive scientific services to diverse industries. The company specializes in contract research and manufacturing services, offering a range of services including discovery chemistry and biology, safety assessment, large molecule and chemical development, formulation development, stability studies, and polymer research. It also focuses on integrated discovery and development along with clinical development. Founded on November 18, 1993, the company is based in Bangalore, India.

Tags

Nervous System Diseases

Other Diseases

Immune System Diseases

Small molecule drug

Bispecific antibody

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

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Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	2
Hemic and Lymphatic Diseases	1
Infectious Diseases	1
Immune System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	4
Bispecific antibody	1

Top 5 Target	Count

CGRP x CGRP receptor	2
1,3-beta-glucan synthase	1
GPR52(G protein-coupled receptor 52)	1
CD123 x TCRGV9	1

Drugs associated with Syngene International Ltd.

Ibrexafungerp Citrate

Target

1,3-beta-glucan synthase

Mechanism

1,3-beta-glucan synthase inhibitors [+1]

Active Org.

Syngene International Ltd. [+3]

Originator Org.

SCYNEXIS, Inc.

Active Indication

Candidiasis, Vulvovaginal [+10]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Jun 2021

HTL-0041178

Target

GPR52

Mechanism

GPR52 agonists

Active Org.

Syngene International Ltd.

Originator Org.

Syngene International Ltd.

Active Indication

Schizophrenia

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Anti-TRGV9/anti-CD123 bispecific antibody (Janssen Biotherapeutics)

Target

CD123 x TCRGV9

Mechanism

CD123 inhibitors [+1]

Active Org.

Syngene International Ltd. [+1]

Originator Org.

Janssen Biotherapeutics

Active Indication

Acute Myeloid Leukemia

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Syngene International Ltd.

CTRI/2024/01/061637

/ RecruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial toEvaluate the Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis - COSMIC – IPF

Start Date07 Mar 2024

Sponsor / Collaborator

Syngene International Ltd.

CTRI/2024/01/061635

/ Active, not recruitingPhase 2

A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K d/?, and SIK3 Inhibitor, in Patients with Metastatic Triple Negative Breast Cancer (TNBC) - NIL

Start Date01 Feb 2024

Sponsor / Collaborator

Syngene International Ltd.

[+1]

CTRI/2023/04/052008

/ Not yet recruitingPhase 4

A Multicenter, Open-label, Single-arm, Post Approval for Restricted use under Emergency Situation Study, to Evaluate the Safety and Efficacy of Injection Remdesivir 100mg (Lyophilized) Manufactured by Syngene International limited in Patients with Corona Virus Disease 2019.

Start Date05 May 2023

Sponsor / Collaborator

Syngene International Ltd.

[+1]

100 Clinical Results associated with Syngene International Ltd.

0 Patents (Medical) associated with Syngene International Ltd.

217

Literatures (Medical) associated with Syngene International Ltd.

26 Dec 2024·Journal of Medicinal Chemistry

Discovery of a Novel Mutant-Selective Epidermal Growth Factor Receptor Inhibitor Using an In Silico Enabled Drug Discovery Platform

Article

Author: Koldsø, Heidi ; Parr, Brendan T. ; Konst, Zef A. ; Bhat, Sathesh ; Shetty, Rajesha ; Atsriku, Christian ; Santhanakrishnan, Sridhar ; Igawa, Hideyuki ; Shelley, Mee ; Kurhade, Suresh E. ; Guo, Jiaye ; Amberg-Johnson, Katherine ; Negri, Ana ; Latthe, Prashant ; Gerasyuto, Aleksey I. ; Levinson, Adam ; Futran, Alan S. ; Verras, Andreas ; Bell, Jeffrey A. ; Bos, Pieter H. ; Therrien, Eric ; Pelletier, Robert D. ; Dahlgren, Markus K. ; Svensson, Mats ; Liu, Zhijian

Despite the success of first, second, and third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer with classical EGFR mutations (L858R or Exon 19 deletions), disease progression occurs due to the acquisition of T790M and C797S resistance. Herein, we report a physics-based computationally driven lead identification approach that identified structurally unique imidazo[3.2-b]pyrazoles as reversible and wild-type-sparing EGFR TKIs of classical mutations bearing both T790M and C797S. During profiling of imidazo[3.2-b]pyrazoles, we elucidated the bioactivation mechanism causing CYP3A4/5 time-dependent inhibition (TDI) and found key modifications to mitigate the TDI. Compound 31 inhibited EGFR L858R/T790M/C797S in biochemical assays with a K_i = 2.1 nM and EGFR del19/T790M/C797S in a Ba/F3 cellular assay with an IC₅₀ = 56.9 nM. The deuterated analogue of 31 (38) demonstrated dose-dependent tumor growth inhibition in a Ba/F3 EGFR del19/T790M/C797S CDX model by 47% at 50 mg/kg BID and 92% at 100 mg/kg BID.

15 Nov 2024·Organic Process Research & Development

Analytical Artifact Due to Residual HCN in Acetonitrile: Identification and Control Strategies

Author: Young, Joel ; Gupta, Riddhi ; Bajpai, Lakshmikant ; Vachhani, Himanshu ; Kushwah, Bhoopendra Singh ; Kadambar, Vasantha Krishna ; Sunny, Denna

Mismatch in the potency from quant. 1H NMR (∼96%) and the calculated potency (∼94%) of an aldehyde intermediate led to the investigation of an unknown impurity peak observed in the chromatog.The HR-MS/MS anal. of the unknown impurity suggested it to be the cyanohydrin derivative of the corresponding aldehyde intermediate with the addition of ∼27 amu.Further investigation was performed using analogous 3-Me iso-nicotinaldehyde as a model compoundA postcolumn hydrogen to deuterium exchange (H/D exchange) experiment further supported the proposed impurity structure as cyanohydrin.The source of HCN for the possible generation of this impurity was traced to certain brands of acetonitrile used duirng the anal., where the presence of HCN as a contaminant was confirmed and quantified using ion chromatog.The aforementioned model compound was used to investigate the effect of other parameters like diluent composition, sample temperature and storage time, pH of the diluent, and duration of sonication, which impact the formation of such artifact impurity.Based on the results of all the experiments, mitigation strategies were proposed to avoid/control the formation of these impurities during the anal. processing such as use of methanol or HCN-free acetonitrile as a sample diluent, reduced composition of acetonitrile in the diluent, and use of freshly prepared solutions for injections to avoid longer storage time specially when certain sensitive substrates like aldehydes and ketones are analyzed.To evaluate if the formation of this impurity is limited to the compound of interest or if it is a common artifact peak for other similar compounds, various substrates involving aldehyde and ketone functional groups were analyzed under similar anal. conditions.The results indicated that aldehydes were more reactive than ketones, specifically the aldehydes containing a heterocyclic ring such as pyridine were prone to generate the cyanohydrin impurity.

15 Nov 2024·Organic Process Research & Development

Development of a Scalable Process for the Synthesis of Cyclopropyl-Methyl-Proline with Complex Stereochemistry: A Key Building Block of Factor D Inhibitors

Author: Chukka, Tanish ; Ganapathy, Suman ; Burt, Justin L. ; Lahoti, Anand M. ; Rai, Sankappa ; Mani, Anbazhagan ; Bilidegalu N, Devaraju ; Huddar, Sameerana ; Chandran, Prabu ; Soman, Ashish ; Hashimoto, Akihiro ; Tipparaju, Suresh K. ; Kumara, Prasanna ; AN, Guruprasad ; Phadke, Avinash ; Datta, Swarup ; Raju, Tirumani ; Ferretti, Antonio C.

The development of a scalable process for a complex intermediate featuring a chiral, quaternary cyclopropane moiety presented significant challenges.We report two generations of synthetic strategies appropriate for the resp. stages of development.The initial approach utilized a stereoselective Simmons-Smith cyclopropanation of (R)-pyroglutamic acid ester, which predominantly yielded the undesired stereoisomer.To circumvent this issue, we implemented a strategy that combined isomerization, recycling of the undesired isomer, and selective crystallization to improve the yield of the desired product.An important insight was that the Simmons-Smith cyclopropanation exhibited opposite stereoselectivity with a benzoyl ester of a prolinol substrate, resulting in the desired stereoisomer as the major product.This understanding enabled the development of a second-generation process that facilitated the large-scale production of the targeted intermediate, thus supporting the advancement of clin. trials.

News (Medical) associated with Syngene International Ltd.

18 Nov 2024

·www.biopharmadive.com

Reducing variability in gene expression: bottlenecks and solutions

Rise of the CHO cell lineChinese Hamster Ovary (CHO) cells have played a pivotal role in the production of biopharmaceutical proteins since their introduction in the late 20th century. Initially derived from the ovaries of Chinese hamsters in the 1950s, CHO cells were first utilized for recombinant protein production in the 1980s. Their significance in biopharmaceutical manufacturing stems from their ability to grow in suspension cultures, high adaptability to various growth conditions, and capacity for post-translational modifications that are critical for the functionality of therapeutic proteins. CHO cells are particularly valued for their ability to produce complex glycoproteins, which are essential for the efficacy and safety of many biologics, including monoclonal antibodies and therapeutic proteins. Overtime, CHO cells have become the gold standard in cell line development, contributing to the successful commercialization of numerous life-saving treatments. Their reliability, scalability, and established regulatory pathways further underscore their importance in the biopharmaceutical sector, making them an integral component in the quest to meet global health challenges.How CHO cells evolved overtime to become the gold standard in cell line developmentPermission granted by SyngeneBottlenecks in traditional cell line developmentThe traditional cell line development (CLD) workflow, generally starts with the transfection of the gene of interest into the chosen cell line, followed by selection, limiting dilution, and cell banking. A major bottleneck in this traditional CLD workflow is random integration. Researchers have little control over where the gene integrates, necessitating extensive screening of numerous clones to identify the best producers. Additionally, assessing quality parameters across all clones is often impractical.Consequently, finding the ideal clone with high titers and the right quality parameters can prove to be a complex and time-intensive endeavor.The traditional approach has two major shortcomings low integration efficiency and heterogeneity in gene expression due to position effects. This heterogeneity arises when the gene integrates at different sites in the genome, leading to varied expression levels among clones. To mitigate these position effects, several technologies have emerged. Chart of typical cell line development processPermission granted by SyngeneApproaches to mitigate the position effectOne of the approaches is the use of insertion of genetic elements into the vector backbone which have shown to reduce position effects and enhance stability by preventing transgene silencing and ensuring consistent, stable, high-level gene expression, regardless of the chromosomal integration site, another approach is, platform expression systems employing targeted integration can further reduce the impact of position effects. These systems specify a “landing pad“ in the genome for gene insertion, minimizing variability in gene expression by controlling integration sites. Traditional homologous recombination has been used for specific gene integration, while newer methods, such as nuclease-mediated targeting, utilize nucleases to create double-strand breaks, facilitating precise gene insertion. Recombinasesproteins like Cre, PhiC31, FLP, and BxB1enable accurate integration at sequence-specific sites by catalyzing recombination between predefined locations. CRISPR-Cas technology has further enhanced gene editing capabilities. It allows for rapid and efficient modifications that enable precise insertion at single or multiple loci in mammalian genomes, including CHO cells. The use of multi-copy vectors has also been shown to increase the number of integrated gene copies, contributing to higher overall yields.Harnessing the Power of TransposonsTransposon-mediated semi-targeted integration represents a significant advancement in the cell line development (CLD) workflow, particularly in addressing the inefficiency of traditional methods. By utilizing a transposase system, this approach allows for the semi-targeted integration of transgenes into the genome, dramatically reducing the number of clones that need to be screened. Chart of random integration and transposase-mediated integrationPermission granted by SyngeneUnlike random integration which often leads to genetic scrambling and necessitates extensive screening to identify functional clones, semi-targeted integration enhances both integration efficiency and expression levels. The transposon as a mobile DNA element, can integrate the entire construct at multiple locations in the genome through a cut-and-paste mechanism. This means that most cells receive a fully functional construct, resulting in higher copy numbers and improved stability of expression. As there is significant reduction in screening number of clones to get the best producer, consequently, the timeline for developing stable cell lines is significantly shortened, enabling researchers to identify high-yield clones more easily with desired qualities. This in turn, has streamlined the path toward successful biopharmaceutical production. '

Gene Therapy

14 Oct 2024

·www.pharmaceutical-technology.com

ENHERTU gains conditional approval in China to treat NSCLC

ENHERTU is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. Credit: Nemes Laszlo/Shutterstock. Daiichi Sankyo and AstraZeneca ‘s ENHERTU has been conditionally approved by China’s National Medical Products Administration (NMPA) as a single agent for adult patients with a specific type of non-small cell lung cancer (NSCLC). Free Whitepaper Intensified Biomanufacturing of monoclonal antibodies Using an intensified fed-batch process is a viable alternative for higher protein production at a large scale without expanding the current manufacturing footprint. Syngene’s expertise in the field is covered in this white paper. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. Go deeper with GlobalData Reports LOA and PTSR Model - DF-9001 in Non-Small Cell Lung Cancer Reports LOA and PTSR Model - Eniluracil in Metastatic Breast Cancer Data Insights The gold standard of business intelligence. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Syngene Thematic and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The therapy is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. It marks the fourth approval in China for ENHERTU, which has been authorised for use in three different tumour types: HER2-low metastatic breast cancer, and HER2-positive advanced or metastatic gastric cancer . ENHERTU, a HER2-directed antibody-drug conjugate (ADC), was discovered by Daiichi Sankyo and is being developed and commercialised in collaboration with AstraZeneca. The conditional approval is based on the outcomes of the DESTINY-Lung02 and DESTINY-Lung05 Phase II studies. See Also: Evergreen Theragnostics Radiopharmaceutical Manufacturing Facility, New Jersey, US Merck Biotech Development Center, Corsier-sur-Vevey, Switzerland In the DESTINY-Lung02 trial, ENHERTU achieved the primary endpoint with a confirmed overall response rate (ORR) of 49%, 49 partial responses (PRs) and one complete response (CR), as evaluated by blinded independent central review (BICR). The DESTINY-Lung05 trial demonstrated a confirmed ORR of 58.3%, one CR and 41 PRs, as determined by an ICR. AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “This approval of ENHERTU represents the first HER2 directed therapy approved in China for the treatment of HER2 mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. “It also reinforces the importance of testing for predictive biomarkers, including HER2 mutations in lung cancer at the time of diagnosis, to ensure patients can receive the most appropriate treatment for their specific disease.” The full approval of ENHERTU for this indication in China will depend on the clinical benefits observed in the confirmatory trial. Enhertu was approved in the US as the first tumour-agnostic HER2-directed therapy in April 2024 for previously treated patients with metastatic HER2-positive solid tumours. Free Whitepaper Intensified Biomanufacturing of monoclonal antibodies Using an intensified fed-batch process is a viable alternative for higher protein production at a large scale without expanding the current manufacturing footprint. Syngene’s expertise in the field is covered in this white paper. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Syngene Thematic Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Syngene Thematic and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Clinical ResultDrug ApprovalPhase 2ADC

10 Oct 2024

·endpts.com

Clients add pressure to CDMOs to source raw materials outside of China, execs say

MILAN — CDMOs are increasingly fielding inquiries from biopharma clients on how reliant they are on China for their raw materials, off the back of industry anxiety on how the Biosecure Act would play out, manufacturing executives told Endpoints News . “We’ve had customers coming in and saying, ‘I want you to make this product for me. Tell me how much of a China dependency you have in that exactly’,” Aragen Life Sciences’ Chief Commercial Officer Ashu Tandon said on the sidelines of the annual Convention of Pharmaceutical Ingredients confab in Milan. Aragen sources around a quarter of its raw materials from China, which is a drop from about 60% from three years ago, Tandon added. Swiss-headquartered CDMO CordenPharma is also looking for a more localized approach for raw materials, Stephen Houldsworth, VP and global head of platform management and marketing, told Endpoints News . “We have serious conversations with our customers over our raw material strategy,” he added. But shifting raw material supply chains out of China is not straightforward because it’s been the go-to for decades, particularly because of lower costs, Houldsworth said. And cost impact is at the forefront of manufacturers’ agendas, considering other external pressures like the Inflation Reduction Act in the US, which is likely to squeeze the cost of raw materials for affected drugs, Tandon added. Manufacturers are looking to India as an alternative to China. India-based Aragen is building its raw material sourcing at a local level, as it focuses on investing in local suppliers and startups to help the country’s raw material supply, Tandon said. The Biosecure Act passed the House in September, with many biopharma companies assessing their supply chains. According to a CPHI report , 70% of survey respondents said geopolitical tensions are the biggest threat to biological supply chain resilience. While CDMOs outside of China have spotlighted how the bill would be an opportunity for them to bolster their client list, such manufacturers are also dependent on China to varying degrees on their raw materials. The bill has a grandfather clause that gives biopharma and CDMO companies some time to review and potentially make new arrangements. While there’s more discussion about moving raw material sourcing outside China, this overall trend is not new because of the Covid pandemic, India-based CDMO Syngene CEO Jonathan Hunt said. “If we had everything in China — what happens if there’s a problem with China?” Other factors such as reducing manufacturing carbon footprint are also a reason for CDMOs and their biopharma customers to source services more locally, Germany-based Rentschler Biopharma CEO Benedikt von Braunmühl added. The execs said there is doubt if there will be a complete exit out of China in raw material supply. Biopharma companies with candidates in the earlier stages will be more concerned about moving their studies along as quickly as possible, rather than changing suppliers, said Jeremie Trochu, CEO of the Belgium-headquartered manufacturer Ardena. Meanwhile, companies with assets in Phase 3 trials and in commercial production would be more concerned with shifting as they have longer-term plans, he added.

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