Swati Spentose Pvt. Ltd.
Homepage http://www.spentose.com
LinkedIn Profile https://linkedin.com/company/swat***ose-pvt***
HQ Location
India , Maharashtra, Mumbai114, Marine Chambers, 11, New Marine Lines, Mumbai, Maharashtra 400020 India
Swati Spentose Pvt. Ltd. is an API manufacturing company with its corporate office in Mumbai and multiple manufacturing sites in Vapi. We have commissioned the largest manufacturing site for regulated markets for Pentosan Polysulfate Sodium, Lidocaine Base/HCl and Meloxicam.
The facility is WHO-GMP certified, and is audited and approved by the COFEPRIS (Mexico) for Lidocaine, Lidocaine Hydrochloride and Meloxicam. The site is compliant with all major regulatory bodies including US-FDA, MHRA, EDQM and TGA.
The company has CEP for Lidocaine Hydrochloride (#R0-CEP 2013-103-Rev 00), and is in the process of obtaining CEPs for Lidocaine and Meloxicam,
USDMFs have been filed for key products, and the company is in line with GDUFA requirements. Completeness Assessment has been complete for Meloxicam (DMF #18837) and is pending for Lidocaine (DMF #25830) and Lidocaine Hydrochloride (DMF #25963)
Written Confirmation of EU-GMP is available for PPS, Lidocaine, Lidocaine Hydrochloride, Meloxicam and Metform
Pharmaceuticals and Medicine Manufacturing
The Drugs and Medicine industry involves research, development, manufacturing and distribution of pharmaceutical drugs and medicines. Companies in this field focus on preventing and treating illness using medicinal compounds and therapies.
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