DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
02 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
03 1FORMOSA LABORATORIES, INC. Taoyuan TW
04 1HETERO DRUGS LIMITED Hyderabad IN
05 1LAURUS LABS LIMITED Hyderabad IN
06 1LAURUS LABS PRIVATE LIMITED Hyderabad IN
07 1MACLEODS PHARMACEUTICALS LIMITED Mumbai IN
08 2MELODY HEALTHCARE PVT. LTD. Boisar IN
09 1MOREPEN LABORATORIES LIMITED Baddi IN
10 2MSN PHARMACHEM PRIVATE LIMITED Pashamylaram Village IN
11 1SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN
12 2TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
13 2TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN
14 2UNIMARK REMEDIES LIMITED Mumbai IN
15 1ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN
01 13Montelukast sodium
02 1Montelukast sodium, Alternate process
03 1Montelukast sodium, ID 6177
04 1Montelukast sodium, MK
05 1Montelukast sodium, Milled and micronised
06 1Montelukast sodium, Process B
07 1Montelukast sodium, Process II
08 1Montelukast sodium, Process-II
01 2China
02 15India
03 2Israel
04 1Taiwan
01 2Expired
02 1Suspended by Holder
03 15Valid
04 2Withdrawn by Holder
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2012-115 - Rev 03
Status : Valid
Issue Date : 2023-07-12
Type : Chemical
Substance Number : 2583
Certificate Number : CEP 2012-186 - Rev 01
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 2583
Certificate Number : R1-CEP 2013-278 - Rev 00
Status : Valid
Issue Date : 2021-07-23
Type : Chemical
Substance Number : 2583
Montelukast Sodium, Alternate Process
Certificate Number : CEP 2013-311 - Rev 02
Status : Valid
Issue Date : 2024-11-25
Type : Chemical
Substance Number : 2583
Certificate Number : R0-CEP 2019-211 - Rev 00
Status : Valid
Issue Date : 2022-06-03
Type : Chemical
Substance Number : 2583
Certificate Number : R1-CEP 2015-135 - Rev 00
Status : Valid
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 2583
Certificate Number : R1-CEP 2011-131 - Rev 02
Status : Valid
Issue Date : 2022-02-24
Type : Chemical
Substance Number : 2583
Certificate Number : CEP 2017-131 - Rev 05
Status : Valid
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 2583
Montelukast Sodium, Process-II
Certificate Number : CEP 2024-151 - Rev 00
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 2583
Certificate Number : R1-CEP 2014-115 - Rev 01
Status : Valid
Issue Date : 2021-07-16
Type : Chemical
Substance Number : 2583
A Montelukast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Montelukast, including repackagers and relabelers. The FDA regulates Montelukast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Montelukast 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 Montelukast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Montelukast supplier is an individual or a company that provides Montelukast active pharmaceutical ingredient (API) or Montelukast finished formulations upon request. The Montelukast suppliers may include Montelukast API manufacturers, exporters, distributors and traders.
click here to find a list of Montelukast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Montelukast CEP of the European Pharmacopoeia monograph is often referred to as a Montelukast Certificate of Suitability (COS). The purpose of a Montelukast CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Montelukast EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Montelukast to their clients by showing that a Montelukast CEP has been issued for it. The manufacturer submits a Montelukast CEP (COS) as part of the market authorization procedure, and it takes on the role of a Montelukast CEP holder for the record. Additionally, the data presented in the Montelukast CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Montelukast DMF.
A Montelukast CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Montelukast 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 Montelukast suppliers with CEP (COS) on PharmaCompass.
We have 14 companies offering Montelukast
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