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WHO successfully completes inspection of Strides Pharma's Puducherry unit

WHO successfully completes inspection of Strides Pharma's Puducherry unit

WHO successfully completes inspection of Strides Pharma's Puducherry unit
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By CNBCTV18.com Jan 23, 2023 2:53:03 PM IST (Published)

The Puducherry facility of the company caters to the United States and other regulated markets and institutional businesses.

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Bengaluru-headquartered Strides Pharma Science Ltd. has announced the completion of an inspection by the World Health Organisation (WHO) at its facility located in Puducherry.

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The WHO carried out an inspection between January 16 and January 20. The Puducherry facility of the company caters to the United States and other regulated markets and institutional businesses.
Last week, Strides Pharma’s subsidiary Stelis Biopharma received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) on the successful closure of its inspection specific to drug-device combination products.
An EIR from USFDA was received for the drug-device combination to be commercialised from the company’s flagship facility in Bengaluru.
Last month, the Contract Development and Manufacturing Organisation (CDMO) partner of Stelis Biopharma also received approval for a key Abbreviated New Drug Application (ANDA) from the USFDA. The filing for the product was done from Stelis Biopharma’s flagship facility in Bengaluru.
The flagship facility offers unique capabilities of drug products for all injectable formats, including cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials
Stelis Biopharma continues to onboard new partners for its integrated capabilities offered through three manufacturing facilities and it continues to build its clientele with global partnerships and onboarding of new programs on the drug substance and drug product side.
It remains a strong biologics CDMO player given its comprehensive capabilities, high-quality systems, large drug substance (DS) scale across modalities, and significant fill-finish capacity.
Shares of Strides Pharma are trading at Rs 337.80, up 2.86 percent.
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