DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Polpharma
03 1Ami Lifesciences Private Limited
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1Amoli Organics
07 1Aurobindo Pharma Limited
08 1HONOUR LAB LTD
09 1Harman Finochem
10 2Jiangsu Lianhuan Pharmaceutical
11 1Laurus Labs
12 1Lupin Ltd
13 3MSN Laboratories
14 1Macleods Pharmaceuticals Limited
15 1Mankind Pharma
16 1Viatris
17 1Wisdom Pharmaceutical
18 1Zhejiang Tianyu Pharmaceutical Co., Ltd
19 1Zhuhai Rundu Pharmaceutical
01 1SACUBITRIL AND VALSARTAN
02 1SACUBITRIL AND VALSARTAN (AMORPHOUS)
03 1SACUBITRIL AND VALSARTAN (FORM-S)
04 1SACUBITRIL VALSARTAN 3NA COMPLEX
05 3SACUBITRIL VALSARTAN SODIUM
06 1SACUBITRIL VALSARTAN SODIUM (INTERNAL CODE: LCZ696)
07 1SACUBITRIL VALSARTAN SODIUM ON COLLOIDAL SILICON DIOXIDE
08 1SACUBITRIL VALSARTAN TRISODIUM (AMORPHOUS)
09 1SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATE
10 1SACUBITRIL VALSARTAN TRISODIUM SALT HEMIPENTAHYDRATE
11 1SACUBITRIL-VALSARTAN PREMIX
12 7SACUBITRIL/VALSARTAN
13 2SACUBITRIL/VALSARTAN COMPLEX
01 5China
02 14India
03 1Israel
04 1Poland
05 1U.S.A
01 21Active
02 1Inactive
01 14Complete
02 8Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-11-08
DMF Number : 31574
Submission : 2017-08-29
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-04
Pay. Date : 2017-12-20
DMF Number : 32337
Submission : 2017-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37994
Submission : 2023-03-09
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-12-20
DMF Number : 33457
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-27
Pay. Date : 2019-02-05
DMF Number : 33452
Submission : 2019-02-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-08
Pay. Date : 2019-02-01
DMF Number : 33455
Submission : 2019-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-30
Pay. Date : 2019-04-15
DMF Number : 33398
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-19
Pay. Date : 2018-10-31
DMF Number : 32325
Submission : 2017-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32171
Submission : 2017-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32254
Submission : 2017-12-07
Status : Active
Type : II
A Sacubitril-Valsartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril-Valsartan, including repackagers and relabelers. The FDA regulates Sacubitril-Valsartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril-Valsartan 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 Sacubitril-Valsartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sacubitril-Valsartan supplier is an individual or a company that provides Sacubitril-Valsartan active pharmaceutical ingredient (API) or Sacubitril-Valsartan finished formulations upon request. The Sacubitril-Valsartan suppliers may include Sacubitril-Valsartan API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril-Valsartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sacubitril-Valsartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril-Valsartan active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril-Valsartan DMFs exist exist since differing nations have different regulations, such as Sacubitril-Valsartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril-Valsartan DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril-Valsartan USDMF includes data on Sacubitril-Valsartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril-Valsartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril-Valsartan suppliers with USDMF on PharmaCompass.
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