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

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01 Alembic Pharmaceuticals Limited (3)

02 CSPC Pharmaceutical Group (2)

03 Calyx Chemicals & Pharmaceuticals Limited (1)

04 HEC Pharm (2)

05 Hainan Poly Pharm (1)

06 ITF CHEMICAL LTDA (1)

07 Jubilant Generics (1)

08 Lupin Ltd (2)

09 MAHIMA LIFE SCIENCES PRIVATE LTD (1)

10 PJ healthcare (1)

11 Quimica Sintetica S.A. (1)

12 Sandoz B2B (1)

13 Sterile India Pvt. Ltd (1)

14 Taro Pharmaceutical Industries (1)

15 Teva API (3)

16 Wockhardt (3)

17 Zhejiang Guobang Pharmaceutical (1)

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01 ANHYDROUS AZITHROMYCIN (1)

02 AZITHROMYCIN (1)

03 AZITHROMYCIN (LYOPHILIZED BULK STERILE) (1)

04 AZITHROMYCIN GRANULES FOR ORAL SUSPENSION (1)

05 AZITHROMYCIN HYDROGENCITRATE (1)

06 AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE (1)

07 AZITHROMYCIN MONOHYDRATE (6)

08 AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK) (1)

09 AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

10 AZITHROMYCIN MONOHYDRATE USP (4)

11 AZITHROMYCIN MONOHYDRATE USP (PROCESS B) (1)

12 AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) (1)

13 AZITHROMYCIN N (1)

14 AZITHROMYCIN TASTE MASKING GRANULES 7.5% (1)

15 AZITHROMYCIN USP (1)

16 AZITHROMYCIN USP (API) (1)

17 AZITHROMYCIN USP (DIHYDRATE) (1)

18 AZITHROMYCIN-FORM I (1)

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01 Brazil (1)

02 China (6)

03 India (13)

04 Israel (3)

05 Spain (1)

06 Switzerland (1)

07 U.S.A (1)

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01 Active (13)

02 Inactive (13)

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01 Complete (7)

02 Blank (19)

URL Supplier Web Content
24754
Active
2011-02-01
Complete
2014-01-06
2013-09-26
II
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18719
Active
2005-08-31
N/A
II
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27713
Active
2013-09-21
N/A
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22331
Active
2008-12-05
Complete
2014-05-16
2014-05-07
II
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18868
Active
2005-10-14
Complete
2012-11-23
2012-12-17
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25820
Active
2012-04-02
Complete
2013-08-23
2013-01-04
II
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27885
Active
2013-12-02
N/A
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15985
Active
2002-05-28
Complete
2013-07-26
2012-11-13
II
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15261
Active
2001-01-24
N/A
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18073
Active
2005-02-11
N/A
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Looking for 83905-01-5 / Azithromycin API manufacturers, exporters & distributors?

Azithromycin manufacturers, exporters & distributors 1

64

PharmaCompass offers a list of Azithromycin 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 Azithromycin manufacturer or Azithromycin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin manufacturer or Azithromycin supplier.

PharmaCompass also assists you with knowing the Azithromycin API Price utilized in the formulation of products. Azithromycin API Price is not always fixed or binding as the Azithromycin Price is obtained through a variety of data sources. The Azithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Azithromycin

Synonyms

Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax

Cas Number

83905-01-5

Unique Ingredient Identifier (UNII)

J2KLZ20U1M

About Azithromycin

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Azithromycin Manufacturers

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

Azithromycin Suppliers

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

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

Azithromycin USDMF

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

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

click here to find a list of Azithromycin 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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