Drug Master Files (DMF)

The following Drug Master Files (Type II) have been submitted to the U.S. Food and Drug Administration (FDA). Customers may reference these DMFs in their ANDA / NDA applications by submitting a Letter of Authorization (LOA) to the FDA.

No.	Product Name	DMF No.	Status
1	Chlorzoxazone	8736	Active
2	Crotamiton	26374	Active
3	Diclofenac Epolamine	24962	Active
4	Diclofenac Sodium	9899	Active
5	Granisetron	25980	Active
6	Granisetron HCl	26504	Active
7	Lamotrigine	030270	Active
8	Metaxalone	24631	Active
9	Naftopidil	26502	Active
10	Phenylephrine HCl	18319	Active
11	Pramoxine HCl	15464	Active
12	Riluzole	26147	Active
13	Rizatriptan Benzoate	28634	Active
14	Sodium Stearyl Fumarate	18189	Active
15	Timolol Maleate	036428	Active
16	Tolperisone HCl	25466	Active
17	Zolmitriptan	27818	Active

The following Master Files have been filed with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Customers may cross-reference these files when applying for manufacturing and marketing approval in Japan.

No.	Product Name	MF No.	Status
1	Atomoxetine HCl	229MF10113	Active
2	Crotamiton	228MF10116	Active
3	Eperisone HCl	221MF10236	Active
4	Lansoprazole	302MF10112	Active
5	Lamotrigine	228MF10086	Active
6	Naftopidil	225MF10172	Active
7	Naftopidil	229MF10072	Active
8	Oxazolam	224MF10023	Active
9	Oxethazaine	223MF10076	Active
10	Rabeprazole Sodium	226MF10145	Active
11	Rizatriptan Benzoate	227MF10229	Active
12	Timolol Maleate	225MF10066	Active
13	Tolvaptan	302MF10031	Active
14	Zolmitriptan	226MF10060	Active
15	Dimemorfan Phosphate	306MF10070	Active

SYN-TECH has obtained CEP certificates (Certificate of Suitability to the Monographs of the European Pharmacopoeia) and filed registrations in multiple countries. Contact our sales team for Letter of Authorization (LOA) requests.

No.	Product Name	Certificate / File No.	Applicant
European Union — CEP (Certificate of Suitability, EDQM)
1	Crotamiton	R1-CEP 2014-260-Rev 01	EDQM
2	Phenylephrine HCl	R1-CEP 2006-231-Rev 01	EDQM
3	Sodium Stearyl Fumarate	CEP 2011-269-Rev 02	EDQM
Germany
1	Tolperisone HCl	1059	BfArM
Korea — Drug Master File (MFDS)
1	Cloperastine HCl	2021-A1-1502	MFDS
2	Diclofenac Sodium	20071025-80-D-8-02	MFDS
3	Timolol Maleate	20130418-201-I-226-06	MFDS
4	Naftopidil	6580-17-ND	MFDS
5	Phenylephrine HCl	20071025-88-D-17-02	MFDS
China — Drug Master File (NMPA)
1	Crotamiton	Y20200001167	NMPA
2	Crotamiton	F20190000650	NMPA
3	Atomoxetine HCl	Y20210000399	NMPA
4	Sodium Stearyl Fumarate	F20180000204	NMPA
Australia — Drug Master File (TGA)
1	Prazosin HCl	E007477	TGA