LIST OF TEST PRODUCTS, COMPARATOR PRODUCTS AND EFFECTIVE SUBMISSION DATE FOR BIOEQUIVALENCE STUDY REPORT
FOR YEAR 2009 - 2010
8 TH LIST
Bil.
TEST
PRODUCTS
(Pharmaceutical
name)
1.
2.
3.
Amoxycillin
Ampicillin
Cephalexin
Comparator Products
Trade Mark/Registration No.
Manufacturer
i) Ospamox 250mg Capsule
(MAL19890611AZ)
Sandoz GmBH, Austria
ii) Ospamox 500mg FilmCoated Tablet
(MAL19890612AZ)
Sandoz GmBH, Austria
iii) Ospamox 1000mg FilmCoated Tablet
(MAL19890613AZ)
Sandoz GmBH, Austria
iv) Moxilen Capsule 250mg
(MAL19860458AZ)
Medochemie Ltd, Cyprus
v) Moxilen Capsule 500mg
(MAL19860465AZ)
Medochemie Ltd, Cyprus
i) Pamecil Capsule 250mg
(MAL19860391AZ)
Medochemie Ltd, Cyprus
ii) Pamecil Capsule 500mg
(MAL19860396AZ)
Medochemie Ltd, Cyprus
i) Ospexin Capsule 250mg
(MAL19890449A)
Sandoz GmBH, Austria
Effective Date for
Submission of BE
Study Report
New Application
Closing Date for Submission of
BE Study Report of Registered
Products
Imported
Products
Local
Products
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
4.
Clindamycin
ii) Ospexin 500mg F/C Tablet
(MAL19890448A)
Sandoz GmBH, Austria
iii) Ospexin 1000mg FilmCoated Tablet
(MAL19890610A)
Sandoz GmBH, Austria
i) Dalacin C Capsule 150mg
(MAL19871766A)
Pfizer PGM, France
ii) Dalacin C Capsules 300mg
(MAL19985498A)
Pfizer, France
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
Patheon Inc, Canada
5.
Cloxacillin
i) Monoclox Capsule 250mg
(MAL19871957AZ)
Medochemie Ltd, Cyprus
As agreed upon in “Mesyuarat Jawatankuasa Kajian
Bioekuivalens Kebangsaan 2/2015, 7th September 2015, the
following products are being added to the existing list of
comparator:i) Cloxacillin Capsule 250mg
Dynapharm (M) Sdn Bhd
(MAL19930225AZ)
6.
Erythromycin
Ethylsuccinate
ii) Cloxacillin Capsule 500mg
(MAL07090901AZ)
Dynapharm (M) Sdn Bhd
iii) Cloxacilla Cap 250mg
(MAL19890418AZ)
Idaman Pharma
Manufacturing Sdn Bhd (Seri
Iskandar)
i) E.E.S. 400 Filmtab
(MAL19870265A)
Abbott Laboratories, US
As agreed upon in “Mesyuarat Jawatankuasa Kajian
Bioekuivalens Kebangsaan 2/2013, 2nd September 2013,
the following product is being added to the existing list of
comparator:-
Axcel Erythromycin ES Tablet
(MAL20020154AZ)
Kotra Pharma (M) Sdn. Bhd
7.
Erythromycin
Stearate
Erythrocin Stearate Filmtab
Abbott Laboratories, US
250mg (MAL19871699AR)
This active ingredient has been granted biowaiver List B based
on unavailability/ inaccessibility of comparator/ innovator
product. Kindly refer biowaiver page on BPFK website for more
information.
8.
Griseofulvin
i) Medofulvin Tablet 125mg
(MAL19860841AZ)
Medochemie Ltd, Cyprus
ii) Medofulvin 500 Tablet
(MAL19860848AZ)
Medochemie Ltd, Cyprus
i) Cravit Tablet 100mg
(MAL19985877A)
Daiichi Sankyo Propharma
Co., Ltd., Shizuoka Plant,
Japan
ii) Cravit 250mg
(MAL20041051AZ)
Pt Kalbe Farma TBK,
Indonesia
iii) Cravit 500mg
(MAL20041052A)
Pt Kalbe Farma TBK,
Indonesia
i) Apo-Minocycline 50mg
(MAL19984325AZ)
Apotex Inc, Canada
ii) Apo-Minocycline 100mg
Capsule
(MAL19984324AZ)
Apotex Inc, Canada
i) Apo-Nitrofurantoin Tablet
100mg
(MAL19984749AR)
Apotex Inc, Canada
9.
10.
11.
Levofloxacin
Minocycline
Nitrofurantoin
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
12.
13.
Norfloxacin
Oseltamivir
Phosphate
i) Urobacid 400mg FilmCoated Tablets
(MAL20021380A)
Merck
Kommanditgesellschaft Auf
Aktein & Co.Werk, Austria
ii) Trizolin 400 F.C. Tablets
(MAL19913447A)
Remedica Ltd, Cyprus
i) Tamiflu Capsules 75mg
(MAL20014188AR)
15.
Phenoxymethyl
penicillin
Terbinafine
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
01/01/2010
01/07/2010
31/12/2010
Roche S.P.A., Italy
F.Hoffmann-LA Roche Ltd,
Switzerland
14.
01/01/2010
ii) Tamiflu Capsule 75mg
(MAL09082799AS)
Cenexi SAS, France
iii) Tamiflu Capsules 75mg
(MAL11030079ACRS)
Catalent Pharma Solutions,
Germany
iv) Tamiflu Capsule 30mg
(MAL09100495AR)
Roche S.P.A., Italy
v) Tamiflu Capsule 45mg
(MAL09100496AR)
Roche S.P.A., Italy
i) Ospen Tablet 250mg
(MAL19860442AZ)
Sandoz GmbH, Austria
Biochemie GmBH, Austria
ii) Ospen (KV) 1000 FilmCoated Tablet
(MAL19872227AZ)
Sandoz GmBH, Austria
i) Lamisil 125mg Tablet
(MAL19930423A)
Novartis Pharm UK Ltd,
United Kingdom
ii) Lamisil 250mg Tablet
(MAL20000273AC)
Novartis Pharm UK Ltd,
United Kingdom
Lamisil Tablet 250mg is no longer marketed in Malaysia. It
can be obtained from Singapore, Hong Kong, China and
Australia (Information obtained from Novartis (M) Sdn. Bhd
dated 26th November 2014 via an email)
16.
Tetracycline
i) Tetracycline MC Capsule
250mg
(MAL19860535A)
Medochemie Ltd, Cyprus
01/01/2010
01/07/2010
31/12/2010
17.
Tinidazole
i) Sporinex Tablet 500mg
(MAL19900273A)
Medochemie Ltd, Cyprus
01/07/2010
01/07/2010
31/12/2010
ii) Tinirem 500 Tablets
(MAL19900270A)
Remedica Ltd, Cyprus
i) Alprim 300 Tablet
(MAL19940099A)
Alphapharm Pty Ltd, Australia
01/07/2010
01/07/2010
31/12/2010
18.
Trimethoprim
Alprim 300mg Tablet can be obtained from Australia and New
Zealand (Information obtained from Pahang Pharmacy dated
17th February 2015 via an email)
Updated on 31/12/2015