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Zhuhai Essex Bio-Pharmaceutical Obtained a GMP Certificate for Preservative-Free Single-Dose Tobramycin Eye Drops
2018.04.12
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Hong Kong, 12 April 2018
ESSEX BIO-TECHNOLOGY LIMITED (“EssexBio” or the “Group”－Stock code: 1061) is pleased to announce that Zhuhai Essex Bio-Pharmaceutical Co.,Ltd, an indirectly wholly-owned subsidiary of the Group, has successfully obtained a Certificate of Good Manufacturing Practices for Pharmaceutical Products (“GMP Certificate”) in respect of the preservative-free single-dose Tobramycin Eye Drops issued by Guangdong Provincial Food and Drug Administration, which is valid up to 29 March 2023.
The preservative-free single-dose Tobramycin Eye Drops was approved from China Food and Drug Administration (“CFDA”) in June 2017. With the GMP Certificate, the Group will launch its Tobramycin Eye Drops in the second quarter of 2018.
In China, Tobramycin Eye Drops has been extensively used for the treatment of various eye infections. Following the approval for production, EssexBio will be the first company to commercialise the preservative-free single-dose Tobramycin Eye Drops in China. There are eight more preservative-free single-dose ocular drugs in different clinical stages of development, which are expected to obtain approval from CFDA for commercialisation in the coming years.
The Board of Directors of EssexBio expects with confidence that the launch of the preservative-free single-dose Tobramycin will enrich the Group’s ocular product portfolios and thus strengthen its market position in China prescription ocular drugs.
ESSEX BIO-TECHNOLOGY LIMITED (“EssexBio” or the “Group”－Stock code: 1061) is pleased to announce that Zhuhai Essex Bio-Pharmaceutical Co.,Ltd, an indirectly wholly-owned subsidiary of the Group, has successfully obtained a Certificate of Good Manufacturing Practices for Pharmaceutical Products (“GMP Certificate”) in respect of the preservative-free single-dose Tobramycin Eye Drops issued by Guangdong Provincial Food and Drug Administration, which is valid up to 29 March 2023.
The preservative-free single-dose Tobramycin Eye Drops was approved from China Food and Drug Administration (“CFDA”) in June 2017. With the GMP Certificate, the Group will launch its Tobramycin Eye Drops in the second quarter of 2018.
In China, Tobramycin Eye Drops has been extensively used for the treatment of various eye infections. Following the approval for production, EssexBio will be the first company to commercialise the preservative-free single-dose Tobramycin Eye Drops in China. There are eight more preservative-free single-dose ocular drugs in different clinical stages of development, which are expected to obtain approval from CFDA for commercialisation in the coming years.
The Board of Directors of EssexBio expects with confidence that the launch of the preservative-free single-dose Tobramycin will enrich the Group’s ocular product portfolios and thus strengthen its market position in China prescription ocular drugs.
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