01 1Ipca Laboratories Limited
02 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Atenolol
02 1Atenolol (production only)
01 1India
02 1Taiwan
Registration Number : 218MF10439
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2024-02-07
Atenolol (for manufacturing purposes only)
Registration Number : 222MF10107
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2010-03-23
Latest Date of Registration : 2010-03-23
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A Atenolol [USAN:USP:INN:BAN:JAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atenolol [USAN:USP:INN:BAN:JAN], including repackagers and relabelers. The FDA regulates Atenolol [USAN:USP:INN:BAN:JAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atenolol [USAN:USP:INN:BAN:JAN] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Atenolol [USAN:USP:INN:BAN:JAN] supplier is an individual or a company that provides Atenolol [USAN:USP:INN:BAN:JAN] active pharmaceutical ingredient (API) or Atenolol [USAN:USP:INN:BAN:JAN] finished formulations upon request. The Atenolol [USAN:USP:INN:BAN:JAN] suppliers may include Atenolol [USAN:USP:INN:BAN:JAN] API manufacturers, exporters, distributors and traders.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Atenolol [USAN:USP:INN:BAN:JAN] Drug Master File in Japan (Atenolol [USAN:USP:INN:BAN:JAN] JDMF) empowers Atenolol [USAN:USP:INN:BAN:JAN] API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Atenolol [USAN:USP:INN:BAN:JAN] JDMF during the approval evaluation for pharmaceutical products. At the time of Atenolol [USAN:USP:INN:BAN:JAN] JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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We have 2 companies offering Atenolol [USAN:USP:INN:BAN:JAN]
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