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Caplin Steriles gets USFDA approval for Argatroban Injection
Posted On: 2021-01-22 01:05:29 (Time Zone: Arizona, USA)
Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single-dose vial presentation, a generic therapeutic equivalent version of (RLD), ARGATROBAN INJECTION, of Hikma Pharmaceuticals Limited.
Caplin has received a CGT (Competitive Generic Therapies) Grant for this ANDA and Caplin is the first approved applicant for such competitive generic therapy, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Therefore, with this approval, Caplin is eligible for 180 days of CGT exclusivity for Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single-Dose Vial, under section
Caplin Steriles partners with JAMP Pharma to produce 6 injectables for Canada
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Caplin Steriles is a subsidiary of Caplin Point
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Caplin Point on Monday announced that its subsidiary Caplin Steriles Limited has partnered with JAMP Pharma Group to produce six injectable to be filed shortly in Canada.
Some of these products have already been filed by Caplin Steriles in the USA.
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Commenting on the transaction, Mr C. C. Paarthipan, Chairman of Caplin PointLaboratories Limited, said: We have targeted Canada as one of our key expansion areas in Regulated Markets and we are excited to work with ]AMP, one of the fastest growing companies in Canada.
The agreement includes six injectable products to be filed for Health Canada approval through JAMP Pharma Group.
Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has entered into a strategic partnership with JAMP Pharma Group for six injectable products to be filed shortly in Canada. Some of these products have already been filed by Caplin Steriles in the USA.
Commenting on the transaction, Mr C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited, said: We have targeted Canada as one of our key expansion areas in Regulated Markets and we are excited to work with ]AMP, one of the fastest growing companies in Canada. We are confident that we will be adding more products to this partnership in due course.