Skip to product content

ACTIVE PHARMACEUTICAL INGREDIENT

Metformin Hydrochloride API

Compare FDA DMF and China CDE records, review documented company-name correspondences, and export complete available data with a personal subscription.

46FDA API DMF recordsFDA list cutoff: 2026-06-30Active (A): 30 · Inactive (I): 16
47CDE API registrationsCDE export captured: 2026-10-05Approved for marketed formulations (A): 43 · Joint review not passed (I): 4

3 documented company-name correspondences

View registry dataSources and methodology

Covers the hydrochloride salt; excludes finished tablets, premixes, granules and added excipients. Registry entries do not establish supplier qualification or availability.

Personal API data subscription

$19.00 per month

$149.00 per year

Billed $149.00 every year

  • Complete available registry records
  • Search and status filters
  • Documented company-name correspondences
  • CSV exports with sources and dates

Reported company names across FDA and CDE records

Use these name correspondences to locate source entries when researching Metformin Hydrochloride API suppliers. Review all supporting records and confirm entity and site details with the relevant company.

Free previewShowing 1 sample records of 3.

1 company-name correspondences

EXEMED PHARMACEUTICALS

Reported name correspondence

FDA DMF list

Reported FDA holder
EXEMED PHARMACEUTICALS
DMF number
25467
Filter FDA records by activity status
Active (A)
Initial submission

NMPA CDE registry

Matching reported CDE name
Exemed Pharmaceuticals
Registration number
Y20200000139
Filter CDE records by joint review status
Approved for marketed formulations (A)
Record updated
View source records and matching method

Matching method

The FDA reported holder name matches an individual semicolon-separated CDE company-name entry after trimming surrounding whitespace and ignoring letter case. This is a name correspondence, not proof of an identical legal entity, manufacturing site or supplier qualification.

FDA DMF list
FDA list cutoff: FDA DMF list: second-quarter 2026 snapshot
DMF number
25467
Activity status
Active (A)
DMF type
II
Initial submission
2011-11-03
Reported holder
EXEMED PHARMACEUTICALS
Reported subject
METFORMIN HYDROCHLORIDE USP
NMPA CDE registry
CDE export captured: NMPA CDE API registry: October 5, 2026 snapshot
Registration number
Y20200000139
Reported substance name
盐酸二甲双胍
Reported company names
  1. Exemed Pharmaceuticals
  2. Exemed Pharmaceuticals
  3. 广州市天润药业有限公司
Reported company addresses
  1. Block No. 628 (A & B) ECP Canal Road, Vill: Luna, Taluka: Padra, District: Vadodara - 391440, Gujarat, India
  2. Block No. 628 (A & B) ECP Canal Road, Vill: Luna, Taluka: Padra, District: Vadodara - 391440, Gujarat, India
  3. 广州市番禺区钟村街汉溪村（汉溪商业中心）泽溪街13号2104
Reported product origin
Imported (进口)
Reported packaging
1kg/桶；2kg/桶；5kg/桶；10kg/桶；15kg/桶；25kg/桶；50kg/桶
Reported specification
Not provided by source
Record updated
2022-11-07
Joint review status
Approved for marketed formulations (A)
Reported validity date
2027-01-23
Source remarks
Not provided by source
FDA DMF list: second-quarter 2026 snapshotNMPA CDE API registry: October 5, 2026 snapshot

Other records remain available below and in the registry tables. A missing name correspondence does not imply a missing registration.

Original reported names are preserved. A CDE company field may contain several named parties; their roles are not inferred from name order. Unmatched names are not treated as ineligible suppliers.

Free preview

More documented company-name correspondences available with a subscription: 2.

US REGULATORY RECORDS

Metformin Hydrochloride FDA Drug Master Files

Compare reported holders, DMF subjects, submission dates and activity status in this dated FDA snapshot.

46 API DMF records · 38 distinct reported holder namesFDA list cutoff:

30Active (A)

16Inactive (I)

A = active; I = inactive. DMFs are neither approved nor disapproved by FDA. These entries do not establish supplier qualification, manufacturing-site approval, dossier access or current availability.

Free previewShowing 3 sample records of 46.

  • MERCK SANTE SASDMF number 5951Active (A)Record details
    DMF number
    5951
    Activity status
    Active (A)
    DMF type
    II
    Initial submission
    1985-08-09
    Reported holder
    MERCK SANTE SAS
    Reported subject
    METFORMIN HYDROCHLORIDE
  • GROUPE LIPHADMF number 11924Inactive (I)Record details
    DMF number
    11924
    Activity status
    Inactive (I)
    DMF type
    II
    Initial submission
    1996-04-17
    Reported holder
    GROUPE LIPHA
    Reported subject
    METFORMIN HYDROCHLORIDE
  • USV PRIVATE LTDDMF number 12647Active (A)Record details
    DMF number
    12647
    Activity status
    Active (A)
    DMF type
    II
    Initial submission
    1997-09-08
    Reported holder
    USV PRIVATE LTD
    Reported subject
    METFORMIN HCL USP

Free preview

More records available with a subscription: 43.

How this profile is compiled
FDA DMF list: second-quarter 2026 snapshot
  • The FDA list includes DMFs received by June 30, 2026 for which acknowledgment letters were sent before July 19, 2026. This page uses the supplied second-quarter workbook, not a live FDA query.
  • Subjects containing METFORMIN are reviewed for substance scope. The 46 included Type II records identify Metformin Hydrochloride or Metformin HCl without a finished dosage form, premix, granule or added excipient in the subject.
  • Twelve related entries are excluded: tablets, blends, granules, DC/SR grades and material with added magnesium stearate. Subject spelling and holder names are preserved; source dates are represented as ISO dates.
  • Multiple DMFs can belong to one holder. Counts describe records or distinct reported names; they are not counts of approved or available suppliers.

CHINA REGULATORY RECORDS

Metformin Hydrochloride NMPA CDE registrations

Review reported company names, product origin and joint-review status in this dated CDE snapshot.

47 exact-name API registration recordsCDE export captured:

43Approved for marketed formulations (A)

4Joint review not passed (I)

CDE A and I describe joint-review status, not FDA activity status. In this snapshot, A denotes approval for use in marketed formulations and I denotes material that has not passed joint review with a formulation. Reported validity dates and status do not independently establish current supplier qualification.

Free previewShowing 3 sample records of 47.

  • MERCK SANTE SAS;MERCK SANTE S.A.S.;默克制药（江苏）有限公司Registration number Y20170002070Approved for marketed formulations (A)Record details
    Registration number
    Y20170002070
    Reported substance name
    盐酸二甲双胍
    Reported company names
    MERCK SANTE SAS;MERCK SANTE S.A.S.;默克制药（江苏）有限公司
    Reported company addresses
    37 Rue Saint Romain,France-69008 Lyon;5 Rue Clement Ader, 62100 Calais;江苏省南通经济技术开发区和兴路168号
    Reported product origin
    Imported (进口)
    Reported packaging
    85公斤/桶
    Reported specification
    Not provided by source
    Record updated
    2024-11-17
    Joint review status
    Approved for marketed formulations (A)
    Reported validity date
    2029-08-28
    Source remarks
    JYHZ1700266
  • 天津太平洋化学制药有限公司;天津太平洋化学制药有限公司Registration number Y20180000014Joint review not passed (I)Record details
    Registration number
    Y20180000014
    Reported substance name
    盐酸二甲双胍
    Reported company names
    天津太平洋化学制药有限公司;天津太平洋化学制药有限公司
    Reported company addresses
    天津市津南区开发区宝源路27号;天津市津南区开发区宝源路27号
    Reported product origin
    Domestic (国产)
    Reported packaging
    25kg/桶
    Reported specification
    Not provided by source
    Record updated
    2018-10-22
    Joint review status
    Joint review not passed (I)
    Reported validity date
    Not provided by source
    Source remarks
    Not provided by source
  • 山东科源制药股份有限公司Registration number Y20180000016Approved for marketed formulations (A)Record details
    Registration number
    Y20180000016
    Reported substance name
    盐酸二甲双胍
    Reported company names
    山东科源制药股份有限公司
    Reported company addresses
    山东济南市山东商河经济开发区科源街
    Reported product origin
    Domestic (国产)
    Reported packaging
    药用低密度聚乙烯袋：25kg/桶。
    Reported specification
    药用低密度聚乙烯袋：25kg/桶。
    Record updated
    2023-08-14
    Joint review status
    Approved for marketed formulations (A)
    Reported validity date
    2027-10-24
    Source remarks
    Not provided by source

Free preview

More records available with a subscription: 44.

How this profile is compiled
NMPA CDE API registry: October 5, 2026 snapshot
  • The source is the supplied October 5, 2026 CDE full-field export. Records are included only where the reported substance name equals 盐酸二甲双胍.
  • Two registrations for 盐酸二甲双胍 + 0.5%硬脂酸镁 are excluded from the API count.
  • All eleven exported fields are retained verbatim, including blank cells, source name variations and semicolon-separated names. Blank values and the literal null are displayed as Not provided by source.
  • The source documentation supplies the A/I interpretation. Consult the official CDE registry for current entries; this profile does not claim live status verification.

Metformin Hydrochloride identity and structure

Metformin Hydrochloride is the hydrochloride salt of metformin. CAS 1115-70-4 and PubChem CID 14219 identify the substance covered here; the free base is a different chemical identity.

Metformin Hydrochloride — 2D chemical structure

Loading molecular structure…

Open structure in PubChem
CAS number
1115-70-4
PubChem: Metformin Hydrochloride
PubChem CID
14219
PubChem: Metformin Hydrochloride
IUPAC name
3-(diaminomethylidene)-1,1-dimethylguanidine;hydrochloride
PubChem: Metformin Hydrochloride
Synonyms
Metformin HCl; 1,1-Dimethylbiguanide hydrochloride
PubChem: Metformin Hydrochloride

Metformin Hydrochloride chemical properties

Formula, molecular weight and exact mass are attributed to the salt record in PubChem. These identifiers support substance matching; supplier specifications, analytical results and batch release documents require separate assessment.

Molecular formula
C4H12ClN5
PubChem: Metformin Hydrochloride
Molecular weight
165.62 g/mol
PubChem: Metformin Hydrochloride

Computed molecular weight reported by PubChem; not a batch specification.

Exact mass
165.0781231 Da
PubChem: Metformin Hydrochloride

Computed monoisotopic mass reported by PubChem.

Related substance and official resources

Compare the free-base identity and consult the original compound and regulatory sources when assessing sourcing requirements.

Metformin free base: CAS 657-24-9

Compare the free base with the hydrochloride salt before specifying a substance in an inquiry.

PubChem: Metformin Hydrochloride

Chemical identifiers, computed properties and the reported molecular structure.

FDA Drug Master File information

Understand the role of a DMF and why an active record is not an FDA product approval.

NMPA CDE API registration data

Consult the official registry for current entries. The table on this page uses the supplied October 5, 2026 snapshot.

Sources and compilation methodology

Chemical facts link to official compound records. Registry tables are extracted from the two supplied files and attributed to their originating agencies; they are dated snapshots, not live status checks.

How this profile is compiled

  • The profile separates Metformin Hydrochloride, CAS 1115-70-4, from metformin free base, CAS 657-24-9. Chemical identity and computed properties follow the corresponding PubChem records.
  • The FDA workbook and CDE full-field CSV are user-supplied source assets. Inclusion and exclusion rules are described beside each registry table; original record fields are preserved apart from converting Excel dates and numeric DMF identifiers to display strings.
  • Cross-registry links use explicit reported names only. No translated company aliases, corporate relationships or manufacturing-site equivalence are inferred.
  • This profile is a draft prepared by APIRFQ. APIRFQ is the designated review responsibility; professional pharmaceutical or regulatory review is pending before formal publication. No completed professional review is claimed.

PubChem: Metformin Hydrochloride

National Center for Biotechnology Information

CAS 1115-70-4, CID 14219, molecular formula, computed molecular weight, exact mass, IUPAC name, synonyms and SMILES.

“165.62 g/mol”

National Center for Biotechnology Information

Computed molecular weight reported by PubChem for CID 14219.

Reference checked / supplied snapshot reviewed:

Open official source

PubChem: Metformin free base

National Center for Biotechnology Information

Separate free-base identity used for the salt-versus-base comparison.

“129.16 g/mol”

National Center for Biotechnology Information

Computed molecular weight reported by PubChem for the free base, CID 4091.

Reference checked / supplied snapshot reviewed:

Open official source

FDA DMF list: second-quarter 2026 snapshot

U.S. Food and Drug Administration

The supplied second-quarter 2026 workbook provides the six original DMF fields. Snapshot cutoff: June 30, 2026; acknowledgment letters sent before July 19, 2026.

“A=active ; I=inactive”

U.S. Food and Drug Administration

FDA activity-status legend. Entries shown here come from the supplied workbook; this link opens the official list information.

Reference checked / supplied snapshot reviewed:

Open official source

FDA: Drug Master Files

U.S. Food and Drug Administration

Official explanation of DMFs and their review in connection with applications that reference them.

“Are neither approved nor disapproved.”

U.S. Food and Drug Administration

FDA describes the regulatory role of DMFs; activity status does not confer product approval.

Reference checked / supplied snapshot reviewed:

Open official source

NMPA CDE API registry: October 5, 2026 snapshot

Center for Drug Evaluation, National Medical Products Administration

The supplied full-field CSV provides eleven original registry fields. Its accompanying collection documentation supplies the A/I interpretation. Current CDE entries were not independently re-queried for this profile.

“盐酸二甲双胍”

Center for Drug Evaluation, National Medical Products Administration

Exact reported substance name in the supplied CDE export. The link opens the originating official registry; it is not a link to the local export.

Reference checked / supplied snapshot reviewed:

Open official source

Metformin Hydrochloride API sourcing questions

What is Metformin Hydrochloride API?

Metformin Hydrochloride is the hydrochloride salt of metformin, also called Metformin HCl. This profile identifies it by CAS 1115-70-4 and PubChem CID 14219; its molecular formula is C4H12ClN5.

Is Metformin Hydrochloride the same substance as Metformin free base?

No. Metformin Hydrochloride is the hydrochloride salt, CAS 1115-70-4. Metformin free base has CAS 657-24-9 and a different molecular formula. Use the correct substance identity when comparing records.

How many API registration records are included?

The supplied second-quarter 2026 FDA workbook yields 46 API DMF records: 30 active and 16 inactive. The October 5, 2026 CDE export yields 47 exact-name registrations for 盐酸二甲双胍: 43 marked A and 4 marked I. These are record counts, not counts of qualified suppliers. Finished tablets, premixes, granules and material containing added excipients are excluded.

Does an active FDA DMF mean FDA approval?

No. A means active and I means inactive in the FDA DMF list. FDA neither approves nor disapproves DMFs; it reviews their technical contents in connection with applications that reference them. An active entry does not by itself establish approval, GMP compliance, current supply or suitability for a specific application.

What do A and I mean in the CDE table?

In the supplied CDE snapshot, A is the status for material approved for use in marketed formulations; I identifies material that has not passed the joint review with a formulation. CDE status is distinct from FDA active or inactive status. Check the current entry and the applicable registration requirements before relying on a record.

How are cross-registry company-name correspondences determined?

Only matching reported names are linked after trimming surrounding whitespace and ignoring letter case. CDE semicolon-separated names are checked individually. This method does not infer aliases, corporate ownership, manufacturing-site equivalence or a supplier relationship. The free preview shows a sample; a personal subscription includes all documented correspondences.

What should I check before selecting a Metformin Hydrochloride supplier?

As a sourcing checklist, request the required specification or pharmacopoeial grade, a representative certificate of analysis, manufacturing-site information and the documents needed for the destination market. Verify current registry status and any required authorization to reference a dossier with the holder. Assess requested GMP or CEP evidence separately; these snapshots do not prove that a listed company holds either.

What does a personal data subscription include?

A personal subscription provides all available registry records and documented company-name correspondences for this profile, with search, filters and CSV exports. It does not include supplier qualification, quotations, inquiry services or live status monitoring.

PubChem: Metformin HydrochloridePubChem: Metformin free baseFDA DMF list: second-quarter 2026 snapshotNMPA CDE API registry: October 5, 2026 snapshotFDA: Drug Master Files

Report a data issue

Contact APIRFQ with the page address, disputed record and supporting source. Include only information needed to investigate the correction.

Contact data support

Prepared by APIRFQReview responsibility: APIRFQProfile date Updated

Metformin Hydrochloride