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List of Drug Master Files (DMF) of Enantone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Bachem AG (1)

02 Sanofi (1)

03 Aspen API (1)

04 Piramal Pharma Solutions (1)

05 Sun Pharmaceutical Industries Limited (1)

06 AmbioPharm (1)

07 Teva API (1)

08 ALP Pharm (1)

09 Anygen (1)

10 Auro Peptides Limited (1)

11 BCN Peptides (1)

12 Chemi SpA (1)

13 Chinese Peptide Company (1)

14 Mallinckrodt Pharmaceuticals (2)

15 Peninsula Laboratories (1)

16 PolyPeptide Group (2)

17 ReaLi Tide Biological Technology (1)

18 Takeda Pharmaceutical (6)

19 Viatris (1)

20 Zhejiang Peptites Biotech Co.,Ltd (1)

21 Blank (1)

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01 LEUPROLIDE (2)

02 LEUPROLIDE (LEUPRORELIN) (1)

03 LEUPROLIDE ACETATE (12)

04 LEUPROLIDE ACETATE (SPECIAL) (1)

05 LEUPROLIDE ACETATE NON-STERILE BULK DRUG SUBSTANCE (1)

06 LEUPROLIDE ACETATE USP (3)

07 LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

08 LEUPRORELIN ACETATE (1)

09 LEUPRORELIN HIGHLY PURIFIED (1)

10 LUPRON DEPOT AND LUPRON DEPOT VEHICLE (1)

11 TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION (1)

12 TAP-144-SR (1M) (1)

13 TAP-144-SR (3M) (22.5MG.) (1)

14 TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE) (1)

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01 China (4)

02 France (1)

03 India (2)

04 Ireland (2)

05 Israel (1)

06 Italy (1)

07 Japan (6)

08 Netherlands (1)

09 South Korea (1)

10 Spain (1)

11 Switzerland (3)

12 U.S.A (4)

13 Blank (1)

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01 Active (17)

02 Inactive (11)

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01 Complete (7)

02 Blank (21)

URL Supplier Web Content
14440
Inactive
1999-10-08
N/A
II
Sanofi Company Banner

EMWA 2024

Not Confirmed

envelop Contact Supplier
28808
Active
2014-11-06
Complete
2021-06-29
2020-11-09
II
URL Supplier Web Content
25128
Active
2011-06-30
N/A
II
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URL Supplier Web Content
27832
Active
2014-01-24
Complete
2014-06-24
2014-01-09
II
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URL Supplier Web Content
26380
Inactive
2012-09-05
N/A
II
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15189
Inactive
2000-12-11
N/A
II
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URL Supplier Web Content
11395
Active
1995-03-24
N/A
II
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URL Supplier Web Content
10416
Active
1993-08-13
N/A
II
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URL Supplier Web Content
9365
Active
1991-09-30
N/A
II
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Looking for 74381-53-6 / Leuprolide Acetate API manufacturers, exporters & distributors?

Leuprolide Acetate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Leuprolide Acetate

Synonyms

74381-53-6, Leuprorelin acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h, Lupron (tn), Mfcd00072080, Fensolvi (tn), Eligard (tn)

Cas Number

74381-53-6

Enantone Manufacturers

A Enantone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enantone, including repackagers and relabelers. The FDA regulates Enantone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enantone 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 Enantone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Enantone Suppliers

A Enantone supplier is an individual or a company that provides Enantone active pharmaceutical ingredient (API) or Enantone finished formulations upon request. The Enantone suppliers may include Enantone API manufacturers, exporters, distributors and traders.

click here to find a list of Enantone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Enantone USDMF

A Enantone DMF (Drug Master File) is a document detailing the whole manufacturing process of Enantone active pharmaceutical ingredient (API) in detail. Different forms of Enantone DMFs exist exist since differing nations have different regulations, such as Enantone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Enantone DMF submitted to regulatory agencies in the US is known as a USDMF. Enantone USDMF includes data on Enantone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enantone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Enantone suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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