Looking for a USFDA certified CDMO for Injectables [ENA17681]
A company that focuses on research, development & manufacturing of APIs & finished formulations is looking for a USFDA-certified CDMO for Isavuconazole Injectable. The required packaging is in 10 ml glass vial with rubber stopper and an aluminum cap with plastic seal. The required quantity is 5,000 units for trial & 10,000 units for exhibit batches. The required temperature should be kept between 2 - 8ºC. The project launch time is 2027 in US & 2029 in EU. The country of distribution is EU & US and geographical preference for service provider is India.
INDEXIM INTERNATIONAL, one of the leading manufacturer, suppliers, exporter and importer of API, Pharmaceutical formulation, Novel molecule, APIs, Vet.-APIs, reference standard, Impurities, Excipients, Intermediates, Solvents, Vitamins, Nutraceuticals and Dietary supplements, silica gel, Regulatory documents service etc.
We are exporting several of our products to Latin American countries, Gulf & Asian, Ukraine, Russia, and also a few products to Australia, UK & USA.
We are also contract manufacturer of APIs and attached is the list of products and by cooperation with other manufacturers in India. Also, most of the products are from WHO cGMP, ISO, GMP manufacturers.
IEC -CODE : 0811024407
FDA No- 20B-168327/21B-168328
ISO 9000 AND GMP APPROVED
18:06, 26 Jul 2023
Greetings from Hostrin Life Sciences!!!
Hostrin offers the following services:
1.We do support Tech transfer and Dossiers for Pharmaceutical, Biopharmaceutical, Nutraceutical, Biotech and Biosimilars in CTD, eCTD, ACTD, ANDA formats. DMF support for API's as well.
Tech transfer support and Registration of Dossiers in MOH /MHRA/EMEA/FDA with 5 modules including BA and BE studies /Clinical studies/trials for finished formulation's in Pharmaceutical, ayurveda, Biotech, Biosimilar, vitamins , Peptides and Transdermal patches too.
2. eCTD publishing with potential softwares like Lorenz/Docubridge/PharmaReady/E-Way addressing post submission queries from all regulatory authorities.
3. Support for Impurity's, Reference standards and RLD's
4. Services for IPR & Regulatory compliance with all risk assessments.
5. Services for Quality Management Systems: GXP/GMP Advisory & EU-GMP/UK-MHRA/TGA/PMDA/WHO-GMP/PICS and USFDA_21_CFR with all GAP filling Audits.
6.Supporting for QBD - SIGMA TECH Software version 3.1 for DOE, Robustness for the R&D in Pharma, Biotech, Biosimilars manufacturers to save the time and cost effective technology.
7. Custom synthesis, contract manufacturing services and conducting BE studies and clinical studies from US-FDA,EU-GMP, UK-MHRA, TGA-Australia approved CRO's/BE Study Centers.
8. Synthetic Resin technologies support.
9. Cleaning validation/ toxicology studies reports (PDE/ADE I OEL) values for commercial manufacturing of APIs and finished formulations.
10. Pharmacovigilance services.
Pls don't hesitate to send your inquiries. For your reference, please go through our website www.hostringlobal.com
For all supply related queries like API, Intermediates, Finished Formulations please visit our website www.cristoneglobal.com
CEO & Managing Director
Hostrin Life sciences
WhatsApp: +91 9949930343 www.hostringlobal.com
04:32, 27 Jul 2023
Hello. I'm with Nexus Pharmaceuticals, LLC. We are a FDA approved manufacturer for sterile injectables based in the Chicagoland area. Here is my email so we can discuss more this opportunity and our website.
04:06, 16 Aug 2023
We can support you on this request
12:47, 25 Aug 2023
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