Email: cspc@cspc.cn
NDA and ANDA Preparation
Levamlodipine Maleate Tablets (Conjupri®)
Conjupri® is the first NDA that has been fully approved by the USFDA in China.
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Metformin Hydrochloride Extended-Release Tablets
Metformin hydrochloride extended-release tablets indicate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin Hydrochloride Tablets
Metformin hydrochloride tablets indicate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Azithromycin Tablets
Azithromycin Tablets are integrated products from API to finished dosage form by CSPC.
Tramadol Hydrochloride Tablets
Tramadol Hydrochloride Tablets are integrated products from API to finished dosage form by CSPC.
Carbamazepine Extended-Release Tablets
Carbamazepine Extended-Release Tables are used to control seizures caused by certain types of epilepsy.
Paliperidone Extended-Release Tablets
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy.
Gabapentin Tablets
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures
Gabapentin Capsules
Gabapentin Capsules are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures
Celecoxib Capsules
Celecoxib Capsules are used to treat various forms of arthritis, short-term pain, and menstrual cramps.
Paroxetine Extended-Release Tablets
Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of:
Esomeprazole Delayed Release Capsules
Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following:
Benzonatate Capsules
Benzonatate Capsules are indicated for the symptomatic relief of cough.
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