Briefer on Delamanid 50 mg Film-Coated Tablet [Deltyba]

The application for registration of Delamanid 50 mg Film-Coated Tablet [Deltyba] was

disapproved on 05 December 2016 citing the non-submission of the required Good
Manufacturing Practice (GMP) Clearance of the foreign drug product manufacturer pursuant to
Administrative Order No. 2013-0022 and FDA Circular No. 2014-016, also known as the
Implementing Guidelines for Administrative Order No. 2013-0022 dated 13 August 2013,
Subject: Guidelines for Current Good Manufacturing Practice (CGMP) Clearance and inspection
of Foreign Drug Manufacturers, which states that Prior to registration, all importers of drug
products must obtain GMP clearance from FDA for each of their foreign drug manufacturer(s)
engaged in any and all operations involved in the production. GMP clearance from FDA is now
hereby a requirement for product registration.

The required FDA Philippines issued GMP clearance was not provided for Fuji Chemical
Industries Co., Ltd. Gohkakizawa (engaged in the preparation of spray-drying solution, spray
drying, drying, mixing, and packaging) and AndersonBrecon Pharmaceuticals Ltd. (engaged in
performing primary and secondary packaging for blisters containing delamanid tablets) which
are involved in the production of the product intended for registration based from section
3.2.P.3.1 Manufacturers and Certificate of Pharmaceutical Product (CoPP) of the submitted
dossier.

Upon addressing the cited requirements that caused the disapproval of the product application, it
is up to the Marketing Authorization Holder now to apply again for initial registration.
Correspondingly, the decking and review of the dossier would be facilitated once the product
application have been filed and received by this Office as per CDRR Memorandum No.:0003,
Series: 2013.