Email: cspc@cspc.cn
NDA and ANDA Preparation
Levamlodipine Maleate Tablets (Conjupri®)
FEATURE
Conjupri® is the first NDA that has been fully approved by the USFDA in China.
DOSAGE FORM
Tablet, oral
INDICATION
1. Hypertension. To use this drug solely or combined with other antihypertensive drugs.
2. Chronic stable angina and variant angina. To use this drug solely or combined with other anti-angina drugs.
Metformin Hydrochloride Extended-Release Tablets
DOSAGE FORM
Tablet, extended release, oral
INDICATION
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
DOSAGE FORM
Tablet, oral
INDICATION
Metformin hydrochloride tablets indicate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Azithromycin Tablets
FEATURE
Azithromycin Tablets are integrated products from API to finished dosage form by CSPC.
DOSAGE FORM
Tablet, oral
INDICATION
Anti-infection
Tramadol Hydrochloride Tablets
FEATURE
Tramadol Hydrochloride Tablets are integrated products from API to finished dosage form by CSPC.
DOSAGE FORM
Tablet, oral
INDICATION
Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.
Carbamazepine Extended-Release Tablets
DOSAGE FORM
Tablet, extended release, oral
INDICATION
Carbamazepine Extended-Release Tables are used to control seizures caused by certain types of epilepsy.
Paliperidone Extended-Release Tablets
DOSAGE FORM
Tablet, extended release, oral
INDICATION
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
DOSAGE FORM
Tablet, oral
INDICATION
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin Capsules
DOSAGE FORM
Capsule, oral
INDICATION
Gabapentin Capsules are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Celecoxib Capsules
DOSAGE FORM
Capsule, oral
INDICATION
Celecoxib Capsules are used to treat various forms of arthritis, short-term pain, and menstrual cramps.
Paroxetine Extended-Release Tablets
DOSAGE FORM
Tablet, extended release, oral
INDICATION
Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of:
• Major Depressive Disorder (MDD)
• Panic Disorder (PD)
• Social Anxiety Disorder (SAD)
• Premenstrual Dysphoric Disorder (PMDD)
Esomeprazole Delayed Release Capsules
DOSAGE FORM
Capsule, delayed release, oral
INDICATION
Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following:
• Treatment of gastroesophageal reflux disease (GERD).
• Risk reduction of NSAID-associated gastric ulcer.
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Benzonatate Capsules
DOSAGE FORM
Capsule, oral
INDICATION
Benzonatate Capsules are indicated for the symptomatic relief of cough.
Contact Us