Veranova: A CDMO that manages complexity with confidence.
01 2Macfarlan Smith Limited@Macfarlan Smith Limited
02 1SCI Pharmtech, Inc
03 1Harman Finochem Limited
04 1IPCA Laboratories Limited
05 1Janssen Pharmaceuticals, Inc
06 2SpecGx LLC
01 1Aging Life Science Co., Ltd.
02 2Alvogen Korea Co., Ltd.
03 1Hwanin Pharmaceutical Co., Ltd.
04 1Korea Janssen Co., Ltd.
05 1Korea Pharma Co., Ltd.
06 2Myungin Pharmaceutical Co., Ltd.
01 8Methylphenidate hydrochloride
01 2India
02 2Ireland
03 1Taiwan
04 3U.S.A
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20210427-209-J-837(1)
Manufacturer Name : Macfarlan Smith Limited@Macf...
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@Three Trees Road, Newbie, Ann...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-09-07
Registration Number : 20180907-209-J-55
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
Registrant Name : Myungin Pharmaceutical Co., Ltd.
Registration Date : 2021-04-27
Registration Number : 20210427-209-J-837
Manufacturer Name : Macfarlan Smith Limited@Macf...
Manufacturer Address : Three Trees Road Newbie, Annan DG12 5QH United Kingdom@10 Wheatfield Road, Edinburgh,...
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2023-07-31
Registration Number : 20230731-209-J-1530
Manufacturer Name : Harman Finochem Limited
Manufacturer Address : Plot No. E-7, E-8, E-9, MIDC Industrial area, Chikalthana, Aurangabad-431 006, Mahara...
Registrant Name : Myungin Pharmaceutical Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-209-J-940
Manufacturer Name : IPCA Laboratories Limited
Manufacturer Address : PO Sejavta Dist. Ratlam (MP) - 457 001, India
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2020-07-15
Registration Number : 20200715-209-J-691
Manufacturer Name : Janssen Pharmaceuticals, Inc
Manufacturer Address : 1440 Olympic Drive, Athens, Georgia (GA) 30601, USA
Registrant Name : Korea Pharma Co., Ltd.
Registration Date : 2023-10-26
Registration Number : 20231012-209-J-1551(A)
Manufacturer Name : SpecGx LLC
Manufacturer Address : 3600 North Second Street, St, Louis, Missouri 63147, USA
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2023-10-12
Registration Number : 20231012-209-J-1551
Manufacturer Name : SpecGx LLC
Manufacturer Address : 3600 North Second Street, St, Louis, Missouri 63147, USA
A Concerta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Concerta, including repackagers and relabelers. The FDA regulates Concerta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Concerta API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Concerta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Concerta supplier is an individual or a company that provides Concerta active pharmaceutical ingredient (API) or Concerta finished formulations upon request. The Concerta suppliers may include Concerta API manufacturers, exporters, distributors and traders.
click here to find a list of Concerta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Concerta Drug Master File in Korea (Concerta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Concerta. The MFDS reviews the Concerta KDMF as part of the drug registration process and uses the information provided in the Concerta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Concerta KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Concerta API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Concerta suppliers with KDMF on PharmaCompass.
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