Strides successfully concludes USFDA inspection at Singapore facility
Bengaluru: Strides Pharma Science Limited has announced that its formulation facility at Singapore underwent a US Food and Drug Administration (USFDA) inspection that ended on August 8, 2022.The inspection was completed successfully with Zero 483 observations. US is one of the key focus markets for Strides and the company has given a growth outlook of US$250m in FY23 for the US business....
Bengaluru: Strides Pharma Science Limited has announced that its formulation facility at Singapore underwent a US Food and Drug Administration (USFDA) inspection that ended on August 8, 2022.
The inspection was completed successfully with Zero 483 observations. US is one of the key focus markets for Strides and the company has given a growth outlook of US$250m in FY23 for the US business. The company has set a target to launch ~ 20 new products every year in the US.
The company has 279 cumulative Abbreviated New Drug Application (ANDA) filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 259 ANDAs have been approved and 20 are pending approval.
The company has a diversified manufacturing base with 5 USFDA approved facilities which are capable of catering to multiple dosage formats including niche capabilities in controlled Substances, Hormones, Nasal Sprays, Gels, Modified Release products, Liquids.
Read also: Strides Pharma Science arm bags USFDA nod for Cyclosporine Softgel Capsules
Strides is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor-funded markets.
The Company's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida).
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd