TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1Teva API India Private Limited
02 1Olon S. p. A.
01 1Amitriptyline Hydrochloride "Teva / Malanpur"
02 1Amitriptyline hydrochloride
01 1Israel
02 1Italy
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Amitriptyline hydrochloride "Teva/Malanpur"
Registration Number : 302MF10137
Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India
Initial Date of Registration : 2020-11-26
Latest Date of Registration : 2020-11-26
Registration Number : 222MF10063
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2010-02-22
Latest Date of Registration : 2010-02-22
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A neuraxpharm Brand of Amitriptyline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of neuraxpharm Brand of Amitriptyline Hydrochloride, including repackagers and relabelers. The FDA regulates neuraxpharm Brand of Amitriptyline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. neuraxpharm Brand of Amitriptyline Hydrochloride 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 neuraxpharm Brand of Amitriptyline Hydrochloride supplier is an individual or a company that provides neuraxpharm Brand of Amitriptyline Hydrochloride active pharmaceutical ingredient (API) or neuraxpharm Brand of Amitriptyline Hydrochloride finished formulations upon request. The neuraxpharm Brand of Amitriptyline Hydrochloride suppliers may include neuraxpharm Brand of Amitriptyline Hydrochloride 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 neuraxpharm Brand of Amitriptyline Hydrochloride Drug Master File in Japan (neuraxpharm Brand of Amitriptyline Hydrochloride JDMF) empowers neuraxpharm Brand of Amitriptyline Hydrochloride 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 neuraxpharm Brand of Amitriptyline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of neuraxpharm Brand of Amitriptyline Hydrochloride 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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