01 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
02 1BIOCON LIMITED Bengaluru IN
03 1DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
04 1Deva Holding A.Ş. Istanbul TR
05 1EMCURE PHARMACEUTICALS LIMITED Pune IN
06 1GLENMARK LIFE SCIENCES LIMITED Mumbai IN
07 1HONOUR LAB LIMITED Hyderabad IN
08 1INTAS PHARMACEUTICALS LIMITED Ahmedabad IN
09 1MAPRIMED S.A. Buenos Aires AR
10 2MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN
11 1RUYUAN HEC PHARM CO., LTD. Shaoguan CN
12 1SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN
13 1SYNTHON BV Nijmegen NL
14 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
15 1TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN
01 13Fingolimod hydrochloride
02 3Fingolimod hydrochloride, Form-I
01 1Argentina
02 1China
03 1Gabon
04 10India
05 1Israel
06 1Netherlands
07 1Turkey
01 16Valid
Certificate Number : CEP 2019-301 - Rev 02
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 2988
Certificate Number : CEP 2020-156 - Rev 02
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 2988
Certificate Number : R0-CEP 2020-352 - Rev 00
Status : Valid
Issue Date : 2022-05-03
Type : Chemical
Substance Number : 2988
Certificate Number : CEP 2022-413 - Rev 00
Status : Valid
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2988
Certificate Number : R0-CEP 2019-171 - Rev 01
Status : Valid
Issue Date : 2023-07-27
Type : Chemical
Substance Number : 2988
Certificate Number : R0-CEP 2020-090 - Rev 01
Status : Valid
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 2988
Certificate Number : R0-CEP 2019-145 - Rev 01
Status : Valid
Issue Date : 2022-07-21
Type : Chemical
Substance Number : 2988
Certificate Number : CEP 2018-259 - Rev 04
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 2988
Certificate Number : CEP 2019-076 - Rev 02
Status : Valid
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2988
Fingolimod Hydrochloride, Form-I
Certificate Number : CEP 2022-164 - Rev 00
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2988
A gilenya manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gilenya, including repackagers and relabelers. The FDA regulates gilenya manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gilenya API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of gilenya manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gilenya supplier is an individual or a company that provides gilenya active pharmaceutical ingredient (API) or gilenya finished formulations upon request. The gilenya suppliers may include gilenya API manufacturers, exporters, distributors and traders.
click here to find a list of gilenya suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A gilenya CEP of the European Pharmacopoeia monograph is often referred to as a gilenya Certificate of Suitability (COS). The purpose of a gilenya CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of gilenya EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of gilenya to their clients by showing that a gilenya CEP has been issued for it. The manufacturer submits a gilenya CEP (COS) as part of the market authorization procedure, and it takes on the role of a gilenya CEP holder for the record. Additionally, the data presented in the gilenya CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the gilenya DMF.
A gilenya CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. gilenya CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of gilenya suppliers with CEP (COS) on PharmaCompass.
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