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aminocaproic acid + neostigmine methylsulfate + naphazoline hydrochloride

Eye drops 1%+0.002%+0.002%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP
Manufacturer #11554
It is the leading pharmaceutical company specializing in ophthalmic products. The company has acquired EU GMP certification and has been under preparation for CGMP approval for both manufacturing sites of multi-dose and single-dose products.

Manufacturer usually replies in 4 days

neostigmine methylsulfate

Injection 0.5 mg/ml, 1 mg/2 ml, 2 mg/4 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
EU GMP
Manufacturer #34185

Established in 1994, this innovative R&D and manufacturing company focuses on the pharmaceutical and health sectors. As a CTD dossier owner and manufacturer, it ensures compliance with international quality standards, operating sophisticated drug production facilities that meet cGMP specifications from regulatory bodies such as NMPA, FDA, and EMA. The company's diverse portfolio includes biologics, small molecules, synthetic biologics, and special traditional Chinese medicines (TCMs), with over 300 product approvals across various categories. Its products are distributed in more than 40 countries and regions, including Singapore, South Korea, Italy, and China.

Manufacturer usually replies in 10 days

neostigmine methylsulfate

Injection 0.5 mg/ml, 1 mg/ml - 10 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
Canada
GMP approvals
FDA, Canada
Manufacturer #20435
A pharmaceutical manufacturer focused on the development, production, marketing and distribution of high-quality, cost-effective injectable and non-injectable medications for the healthcare industry. The company offers a portfolio that includes sterile injectable generic products alongside other specialty pharmaceutical products and supports contract development and manufacturing partnerships, aiming to ensure reliable supply and quality in its pharmaceutical products.

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