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

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01 Polpharma (1)

02 Alembic Pharmaceuticals Limited (1)

03 Apotex Inc (1)

04 Aurobindo Pharma Limited (1)

05 CSPC Pharmaceutical Group (1)

06 CTX Lifesciences (1)

07 Cadila Pharmaceuticals (1)

08 Chemi SpA (2)

09 Chongqing Carelife Pharmaceutical Co., Ltd. (1)

10 Cipla (1)

11 Gador SA (1)

12 Ipca Laboratories (1)

13 Jubilant Generics (1)

14 Lupin Ltd (1)

15 Minsheng Group Shaoxing Pharmaceutical (1)

16 Orchid Pharma (1)

17 Signa S.A. de C.V. (1)

18 Sun Pharmaceutical Industries Limited (1)

19 Teva API (2)

20 Trifarma (1)

21 Viatris (1)

22 Blank (1)

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01 ALEDRONATE SODIUM USP (1)

02 ALENDRONATE MONOSODIUM TRIHYDRATE (1)

03 ALENDRONATE SODIUM (2)

04 ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE (1)

05 ALENDRONATE SODIUM TRIHYDRATE (1)

06 ALENDRONATE SODIUM TRIHYDRATE USP (2)

07 ALENDRONATE SODIUM USP (7)

08 ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE) (1)

09 ALENDRONATE SODIUM USP (TRIHYDRATE) (1)

10 ALENDRONATE SODIUM USP 28 (1)

11 SODIUM ALENDRONATE (4)

12 SODIUM ALENDRONATE TRIHYDRATE (2)

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01 Argentina (1)

02 Canada (1)

03 China (3)

04 India (10)

05 Israel (2)

06 Italy (3)

07 Mexico (1)

08 Poland (1)

09 U.S.A (1)

10 Blank (1)

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01 Active (12)

02 Inactive (12)

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01 Complete (4)

02 Blank (20)

URL Supplier Web Content
15409
Active
2001-04-30
N/A
II
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20031
Active
2006-12-04
N/A
II
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20704
Active
2007-07-11
N/A
II
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14334
Active
1999-08-06
Complete
2019-12-15
2019-12-11
II
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21008
Active
2007-12-03
Complete
2013-11-14
2013-07-30
II
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20415
Active
2007-04-06
N/A
II
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20786
Active
2007-08-14
N/A
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18327
Active
2005-05-03
N/A
II
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20402
Active
2007-04-02
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Looking for 129318-43-0 / Alendronate Sodium API manufacturers, exporters & distributors?

Alendronate Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Alendronate Sodium

Synonyms

129318-43-0, Fosamax, Binosto, Fosamac, Onclast, Monosodium alendronate

Cas Number

129318-43-0

Unique Ingredient Identifier (UNII)

4988K7X26P

About Alendronate Sodium

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Alendronate Manufacturers

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

Alendronate Suppliers

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

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

Alendronate USDMF

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

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

click here to find a list of Alendronate 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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