Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories Limited (Unit-II)
02 1Apitoria Pharma Private Limited
03 1Celgene Chemicals GmbH@Siegfried Ltd
04 1Glenmark Life Sciences Ltd
05 1Hetero Drugs Limited(Unit-I)
06 1Lonza AG
07 1Lupin Limited
01 1Aging Life Science Co., Ltd.
02 2Amgen Korea Ltd.
03 1Kukjeon Pharmaceutical Co., Ltd.
04 1Lee Sung International Co., Ltd.
05 1M-Peak Korea Co., Ltd.
06 1UN U-Generic Co., Ltd.
01 7Apremilast
01 5India
02 2U.S.A
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-12-17
Registration Number : Su434-25-ND
Manufacturer Name : Neuland Laboratories Limited...
Manufacturer Address : Plot Nos. 92, 93, 94, 257, 258, 259 IDA, Pashamylaram, Isnapur Village, Patancheru Ma...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-09-06
Registration Number : 173-42-ND
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Unit-IV, Sy No's 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No...
Registrant Name : Amgen Korea Ltd.
Registration Date : 2017-08-17
Registration Number : Thu17-9-ND
Manufacturer Name : Celgene Chemicals GmbH@Siegf...
Manufacturer Address : Untere Bruhlstrasse 4, 4800 Zofingen, Switzerland@Untere Bruhlstrasse 4, 4800 Zofinge...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2020-11-06
Registration Number : Number 812-13-ND
Manufacturer Name : Glenmark Life Sciences Ltd
Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State...
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-12-17
Registration Number : Thu21-17-ND
Manufacturer Name : Hetero Drugs Limited(Unit-I)
Manufacturer Address : Sy. No.213, 214 & 255, Bonthapally Village, Gummadidala Mandal Sangareddy District Te...
Registrant Name : Amgen Korea Ltd.
Registration Date : 2017-08-11
Registration Number : 17-8-ND
Manufacturer Name : Lonza AG
Manufacturer Address : Chemie, Lonzastrasse, 3930 Visp, Switzerland
Registrant Name : UN U-Generic Co., Ltd.
Registration Date : 2022-11-18
Registration Number : No.827-4-ND
Manufacturer Name : Lupin Limited
Manufacturer Address : Block No.21, Dabhasa, Tal - Padra City : Dabhasa-391 440, Dist - Vadodara, Gujarat st...
A Apremilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apremilast, including repackagers and relabelers. The FDA regulates Apremilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apremilast 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 Apremilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apremilast supplier is an individual or a company that provides Apremilast active pharmaceutical ingredient (API) or Apremilast finished formulations upon request. The Apremilast suppliers may include Apremilast API manufacturers, exporters, distributors and traders.
click here to find a list of Apremilast 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 Apremilast Drug Master File in Korea (Apremilast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apremilast. The MFDS reviews the Apremilast KDMF as part of the drug registration process and uses the information provided in the Apremilast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apremilast 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 Apremilast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Apremilast suppliers with KDMF on PharmaCompass.
We have 7 companies offering Apremilast
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