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Gazette APVMA 7, 4 July 2006 page 25
NOTICELicensing of Veterinary Chemical Manufacturers
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Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has issued, amended or cancelled the manufacturing licences in respect of the following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s web site: http://www.apvma.gov.au.
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1. NEW LICENCES:
PFIZER AUSTRALIA PTY LTD ACN: 008 422 348
32 – 40 Cawarra Road CARINGBAH NSW 2229
Product Types:*Category 6: Single Step
Step(s) of Manufacture:Quality Assurance (QA) of raw materials, analysis and testing: microbiological only.Licence No: 6114
Full licence issued 29/05/06
VICTORIAN CHEMICAL COMPANY PTY LTD ACN: 004 188 863
83 Maffra Street COOLAROO VIC 3048
Product Types:*Category 2: Liquids
Step(s) of Manufacture:Quality Assurance (QA) of raw materials, formulation including blending, filling, primary packaging, primary labelling, analysis and testing: chemical only, release for supply.
Licence No: 2179Full licence issued 25/05/06
2. CHANGES TO EXISTING LICENCES:
ADISSEO AUSTRALIA PTY LIMITED ACN: 098 527 247
66 Antimony Street CAROLE PARK QLD 4300
Product Types:*Category 4: Premixes and supplements
Step(s) of Manufacture:Quality Assurance of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.
Licence No: 4068Amended licence issued 17/05/06, change to licence details and extension of licence scope.
ALLIED BIOTECHNOLOGY PTY LTD ACN: 080 412 139
9/11 Bowmans Road KINGS PARK NSW 2148
Product Types:*Category 1: Immunobiologicals (inactivated autogenous or minor use bacterial, fungal and wart vaccines)
Step(s) of Manufacture:Bacterial and fungal fermentation, wart tissue extraction, formulation including blending, filling, packaging, labelling, sterilisation (heat, chemical), analysis and testing (microbiological, chemical), storage and release for supply.
Licence No: 1038 Amended licence issued 10/05/06, change to licence conditions.
ALPHARMA ANIMAL HEALTH PTY LTD ACN: 088 526 229
24 Parkhurst Drive KNOXFIELD VIC 3180
Product Types:*Category 6: Single Step Manufacture
Step(s) of Manufacture:QA of raw materials, storage and release for supply
Licence No: 6101
Amended licence issued 17/05/06, extension of licence scope.
DERMCARE-VET PTY. LTD. ACN: 010 280 010
22 Aranda Street SPRINGWOOD QLD 4127
Product Types:*Category 1: Sterile and immunobiological products
Step(s) of Manufacture:Formulation including blending, filling, packaging, labelling, storage and release for supply
Licence No: 1052
Amended licence issued 29/05/2006, change of key personnel.
JUROX PTY LIMITED ACN: 000 932 230
85 Gardiners Road RUTHERFORD NSW 2320
Product Types:*Category 1: Sterile products Category 2: Tablets, capsules, creams/lotions, ointments, pastes, powders, sprays and liquids Category 3: Liquids, pastes, sprays and powders
Step(s) of Manufacture:Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating, sterilisation (heat & filtration), microbiological reduction treatment (heat & filtration), analysis and testing (physical & chemical), storage and release for supply.
Licence No: 1042 Amended licence issued 19/05/06, change of key personnel.
MAGAR ENTERPRISES PTY LTD ACN 008 970 643
Units 1 & 2504 Marmion Street BOORAGOON WA 6154
Product Types:*Category 4: Premixes and supplements
Step(s) of Manufacture:Formulation including blending, filling, packaging, labelling, storage and release for supply.
Licence No: 4014
Amended licence issued 19/05/06, change to licence conditions.
MAYNE PHARMA LIMITED
ACN: 097 064 330
1 Lexia Place MULGRAVE VIC 3170
Product Types:*Category 1: Sterile products
Step(s) of Manufacture:Formulation including blending, filling, packaging, labelling, sterilisation (heat and filtration), microbiological reduction treatment (heat and filtration), analysis and testing (physical, chemical and microbiological and Limulus Amoebocyte Lysate test [LAL]), storage and release for supply.
Licence No: 1067
Amended licence issued 02/05/06, update of licence details.
3. LICENCE CANCELLATIONS:
(The APVMA has cancelled the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]).
PAKCARE PTY LTD ACN: 001 118 725
7 Inman Road DEE WHY NSW 2099
Licence No: 6022Cancelled: 12/05/06
Reason for cancellation: s127(1)(e)
SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD ACN: 004 118 594
1408 Centre Road CLAYTON VIC 3168
Licence No: 2081
Cancelled: 01/05/06Reason for cancellation: s127(1)(d)
SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD ACN: 004 118 594
432 Mount Dandenong Road CROYDON VIC 3136
Licence No: 2082
Cancelled: 01/05/06 Reason for cancellation: s127(1)(d)
SUNDAY AUSTRALIA PTY LTD ACN: 101 118 665
118 Links Avenue South EAGLE FARM QLD 4009
Licence No: 2174
Cancelled: 04/05/06Reason for cancellation: s127(1)(d)
4. LICENCE SUSPENSIONS:
(The APVMA has suspended the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]).
BRESAGEN LIMITED ACN: 007 988 767
8 Dalgleish Street THEBARTON SA 5031
Licence No: 1074
Suspended: 19/05/06 (to 19/05/07)Reason for suspension: Voluntary, s127(1)(d)
APVMA Contact:
Kathryn Winterton
Quality Assurance and Compliance
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Ph: (02) 6272 3409
Fax: (02) 6271 6442
Email: kathryn.winterton@apvma.gov.au