28 Jul 2023


Looking for a USFDA-certified CRO for Lurbinectedin Injection [ENA17702]
A company that focuses on research, development & manufacturing of APIs & finished formulations is looking for a USFDA-certified CRO for Lurbinectedin powder for injection. The required packaging is in 30 ml clear glass vial with rubber stopper and an aluminum cap with plastic seal. The required quantity is 1,000 units for trial & exhibit batches. The required temperature for the injectable is in between 2 - 8ºC. The project launch time is 2029. The country of distribution is the US and the geographical preference for service provider is India.

Comments :


Dear Friend,

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

Best Regards,
Andrew P
CEO & Managing Director
Hostrin Life sciences
WhatsApp: +91 9949930343

00:21,  29 Jul 2023


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19:53,  29 Jul 2023
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