Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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01 1Bachem AG
02 1Sanofi
03 1Aspen API
04 1TAPI Technology & API Services
05 1ALP Pharm
06 1Alembic Pharmaceuticals Limited
07 1AmbioPharm
08 1Anygen
09 1Auro Peptides Limited
10 1BCN Peptides
11 1Chemi SpA
12 1Chinese Peptide Company
13 2Mallinckrodt Pharmaceuticals
14 1Peninsula Laboratories
15 1Piramal Pharma Solutions
16 2PolyPeptide Group
17 1ReaLi Tide Biological Technology
18 1Sun Pharmaceutical Industries Limited
19 6Takeda Pharmaceutical
20 1Viatris
21 1Zhejiang Peptites Biotech Co.,Ltd
22 2Blank
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01 2LEUPROLIDE
02 1LEUPROLIDE (LEUPRORELIN)
03 13LEUPROLIDE ACETATE
04 1LEUPROLIDE ACETATE (SPECIAL)
05 1LEUPROLIDE ACETATE NON-STERILE BULK DRUG SUBSTANCE
06 4LEUPROLIDE ACETATE USP
07 1LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE
08 1LEUPRORELIN ACETATE
09 1LEUPRORELIN HIGHLY PURIFIED
10 1LUPRON DEPOT AND LUPRON DEPOT VEHICLE
11 1TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION
12 1TAP-144-SR (1M)
13 1TAP-144-SR (3M) (22.5MG.)
14 1TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE)
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01 4China
02 1France
03 3India
04 2Ireland
05 1Israel
06 1Italy
07 6Japan
08 1Netherlands
09 1South Korea
10 1Spain
11 3Switzerland
12 4U.S.A
13 2Blank
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01 19Active
02 11Inactive
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01 8Complete
02 22Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-02
Pay. Date : 2016-04-29
DMF Number : 13822
Submission : 1998-11-06
Status : Active
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14440
Submission : 1999-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-29
Pay. Date : 2020-11-09
DMF Number : 28808
Submission : 2014-11-06
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 15189
Submission : 2000-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-20
Pay. Date : 2013-01-11
DMF Number : 14763
Submission : 2000-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25128
Submission : 2011-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13150
Submission : 1998-08-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11395
Submission : 1995-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10416
Submission : 1993-08-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9365
Submission : 1991-09-30
Status : Active
Type : II
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PharmaCompass offers a list of Leuprolide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Leuprolide Acetate manufacturer or Leuprolide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Leuprolide Acetate manufacturer or Leuprolide Acetate supplier.
PharmaCompass also assists you with knowing the Leuprolide Acetate API Price utilized in the formulation of products. Leuprolide Acetate API Price is not always fixed or binding as the Leuprolide Acetate Price is obtained through a variety of data sources. The Leuprolide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ELIGARD manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ELIGARD, including repackagers and relabelers. The FDA regulates ELIGARD manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ELIGARD 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 ELIGARD manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ELIGARD supplier is an individual or a company that provides ELIGARD active pharmaceutical ingredient (API) or ELIGARD finished formulations upon request. The ELIGARD suppliers may include ELIGARD API manufacturers, exporters, distributors and traders.
click here to find a list of ELIGARD suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ELIGARD DMF (Drug Master File) is a document detailing the whole manufacturing process of ELIGARD active pharmaceutical ingredient (API) in detail. Different forms of ELIGARD DMFs exist exist since differing nations have different regulations, such as ELIGARD USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ELIGARD DMF submitted to regulatory agencies in the US is known as a USDMF. ELIGARD USDMF includes data on ELIGARD's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ELIGARD USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ELIGARD suppliers with USDMF on PharmaCompass.
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