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

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01 Granules India Limited (2)

02 IOL Chemicals and Pharmaceuticals (2)

03 USV Private Limited (4)

04 Farmhispania (2)

05 Aarti Drugs (1)

06 Auro Laboratories Ltd. (1)

07 Aurobindo Pharma Limited (1)

08 Bausch Health (1)

09 Exemed Pharmaceuticals (1)

10 Hainan Poly Pharm (1)

11 Harman Finochem (1)

12 Indoco Remedies Limited (1)

13 Ions Pharma (1)

14 Ipca Laboratories (2)

15 KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD (1)

16 Karo Pharma (2)

17 Kothari Phytochemicals & Industries (1)

18 Laurus Labs (1)

19 Lupin Ltd (1)

20 Macleods Pharmaceuticals Limited (1)

21 Marksans Pharma (1)

22 Merck Sante SAS (4)

23 Ningxia Heng Kang Pharmaceutical (1)

24 Ningxia Hengkang Technology (1)

25 Olon S.p.A (1)

26 SHANGHAI MEDICINAL LTD (1)

27 SOHAN HEALTHCARE PVT LTD (1)

28 Shandong Keyuan Pharmaceutical Co., Ltd. (2)

29 Shouguang Fukang Pharmaceutical Co., Ltd (1)

30 Smruthi Organics (1)

31 Sun Pharmaceutical Industries Limited (1)

32 Teva API (1)

33 Tianjin Pacific Chemical & Pharmaceutical Co., Ltd (1)

34 UQUIFA (1)

35 Wanbury Limited (5)

36 Wockhardt (1)

37 Blank (3)

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01 BLENDED METFORMIN HCL (1)

02 COMPRESSO MF 95P (1)

03 GLUCOPHAGE 850 MG, FILM-COATED TABLETS (1)

04 GLUCOPHAGE XR 500 MG, PROLONGED RELEASE TABLETS – BULK (REDUCED MASS) (1)

05 METFORMIN ( LA-6023),500MG.&850MG. TABLETS (1)

06 METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS (1)

07 METFORMIN DC 92.6% LUBRICATED GRANULES (1)

08 METFORMIN HCL USP (1)

09 METFORMIN HYDROCHLORIDE (19)

10 METFORMIN HYDROCHLORIDE USP (1)

11 METFORMIN HYDROCHLORIDE (2ND LINE) (1)

12 METFORMIN HYDROCHLORIDE + 0.5% MAGNESIUM STEARATE (1)

13 METFORMIN HYDROCHLORIDE DC GRADE - 90% (1)

14 METFORMIN HYDROCHLORIDE DC GRADE - 95% (1)

15 METFORMIN HYDROCHLORIDE DC GRANULES (1)

16 METFORMIN HYDROCHLORIDE DRUG SUBSTANCE (1)

17 METFORMIN HYDROCHLORIDE DRUG SUBTANCE (1)

18 METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS (1)

19 METFORMIN HYDROCHLORIDE USP (13)

20 METFORMIN HYDROCHLORIDE USP (COARSE) (1)

21 METFORMIN HYDROCHLORIDE USP (PROCESS II) (1)

22 METFORMIN HYDROCHLORIDE USP (PROCESS-II) (1)

23 METFORMIN HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

24 METFORMIN SR GRADE 70% (1)

25 Metformin Hydrochloride USP, as maufactured in Raigad District, INDIA (1)

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01 Canada (1)

02 China (9)

03 France (4)

04 India (31)

05 Israel (1)

06 Italy (1)

07 Spain (3)

08 Sweden (2)

09 Blank (3)

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01 Active (39)

02 Inactive (16)

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01 Complete (15)

02 Blank (40)

Looking for 1115-70-4 / Metformin API manufacturers, exporters & distributors?

Metformin manufacturers, exporters & distributors 1

48

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

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

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

API | Excipient name

Metformin

Synonyms

657-24-9, 1,1-dimethylbiguanide, N,n-dimethylimidodicarbonimidic diamide, Fluamine, Metformine, Metiguanide

Cas Number

1115-70-4

Unique Ingredient Identifier (UNII)

9100L32L2N

About Metformin

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

Metformin Hydrochloride Manufacturers

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

Metformin Hydrochloride Suppliers

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

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

Metformin Hydrochloride USDMF

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

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

click here to find a list of Metformin Hydrochloride 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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