Find Orforglipron Calcium Hydrate manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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Also known as: 2212020-52-3, Ly3502970, Chembl4446782, Ly-3502970, 3-[(1s,2s)-1-[5-[(4s)-2,2-dimethyloxan-4-yl]-2-[(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4h-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4h-1,2,4-oxadiazol-5-one, 3-[(1s,2s)-1-(5-[(4s)-2,2-dimethyloxan-4-yl]-2-{(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methyl-1h-indazol-5-yl)-2-oxo-2,3-dihydro-1h-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5h-pyrazolo[4,3-c]pyridine-5-carbonyl}-1h-indol-1-yl)-2-methylcyclopropyl]-1,2,4-oxadiazol-5(4h)-one
Molecular Formula
C48H48F2N10O5
Molecular Weight
883.0  g/mol
InChI Key
USUWIEBBBWHKNI-KHIFEHGGSA-N
FDA UNII
7ZW40D021M

Orforglipron Calcium Hydrate
1 2D Structure

Orforglipron Calcium Hydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one
2.1.2 InChI
InChI=1S/C48H48F2N10O5/c1-25-18-32(19-26(2)40(25)49)60-42(58-16-15-57(46(58)63)37-11-10-36-33(41(37)50)24-51-55(36)7)39-28(4)56(14-12-34(39)53-60)43(61)38-21-31-20-29(30-13-17-64-47(5,6)23-30)8-9-35(31)59(38)48(22-27(48)3)44-52-45(62)65-54-44/h8-11,15-16,18-21,24,27-28,30H,12-14,17,22-23H2,1-7H3,(H,52,54,62)/t27-,28-,30-,48-/m0/s1
2.1.3 InChI Key
USUWIEBBBWHKNI-KHIFEHGGSA-N
2.1.4 Canonical SMILES
CC1CC1(C2=NOC(=O)N2)N3C4=C(C=C(C=C4)C5CCOC(C5)(C)C)C=C3C(=O)N6CCC7=NN(C(=C7C6C)N8C=CN(C8=O)C9=C(C1=C(C=C9)N(N=C1)C)F)C1=CC(=C(C(=C1)C)F)C
2.1.5 Isomeric SMILES
C[C@H]1C[C@]1(C2=NOC(=O)N2)N3C4=C(C=C(C=C4)[C@H]5CCOC(C5)(C)C)C=C3C(=O)N6CCC7=NN(C(=C7[C@@H]6C)N8C=CN(C8=O)C9=C(C1=C(C=C9)N(N=C1)C)F)C1=CC(=C(C(=C1)C)F)C
2.2 Other Identifiers
2.2.1 UNII
7ZW40D021M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ly3502970

2.3.2 Depositor-Supplied Synonyms

1. 2212020-52-3

2. Ly3502970

3. Chembl4446782

4. Ly-3502970

5. 3-[(1s,2s)-1-[5-[(4s)-2,2-dimethyloxan-4-yl]-2-[(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4h-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4h-1,2,4-oxadiazol-5-one

6. 3-[(1s,2s)-1-(5-[(4s)-2,2-dimethyloxan-4-yl]-2-{(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methyl-1h-indazol-5-yl)-2-oxo-2,3-dihydro-1h-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5h-pyrazolo[4,3-c]pyridine-5-carbonyl}-1h-indol-1-yl)-2-methylcyclopropyl]-1,2,4-oxadiazol-5(4h)-one

7. V6g

8. Orforglipron [inn]

9. Orforglipron [usan]

10. Ly3502970 (orforglipron)

11. Owl833

12. Schembl21175277

13. Gtpl12175

14. 7zw40d021m

15. Ex-a7751

16. Bdbm50514045

17. Akos040733262

18. Glp-1 Receptor Agonist 1;orforglipron

19. Ms-31635

20. Hy-112185

21. Cs-0043632

22. 1,2,4-oxadiazol-5(2h)-one, 3-[(1s,2s)-1-[2-[[(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methyl-1h-indazol-5-yl)-2,3-dihydro-2-oxo-1h-imidazol-1-yl]-2,4,6,7-tetrahydro-4-methyl-5h-pyrazolo[4,3-c]pyridin-5-yl]carbonyl]-5-[(4s)-tetrahydro-2,2-dimethyl-2h-pyran-4-yl]-1h-indol-1-yl]-2-methylcyclopropyl]-

23. 3-[(1s,2s)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1h-indazol-5-yl)-2-oxo-2,3-dihydro-1h-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5h-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4s)-2,2-dimethyloxan-4-yl]-1h-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5h)-ide

2.4 Create Date
2019-01-28
3 Chemical and Physical Properties
Molecular Weight 883.0 g/mol
Molecular Formula C48H48F2N10O5
XLogP36.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area144
Heavy Atom Count65
Formal Charge0
Complexity1950
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2212021-40-2

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2212021-61-7

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2212021-56-0

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 1784678-61-0

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 16732-70-0

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2212021-81-1

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2212021-83-3

End Use API : Orforglipron Calcium Hydrate

About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

Shanghai Minbiotech CB

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

CAS Number : 2415797-61-2

End Use API : Orforglipron Calcium Hydrate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...

Shandong Chenghui Shuangda Pharmaceutical

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

CAS Number : 1784678-61-0

End Use API : Orforglipron Calcium Hydrate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...

Shandong Chenghui Shuangda Pharmaceutical

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

CAS Number : 2212021-56-0

End Use API : Orforglipron Calcium Hydrate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...

Shandong Chenghui Shuangda Pharmaceutical
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FDF Dossiers

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01

Eli Lilly

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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.8MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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02

Eli Lilly

U.S.A
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Not Confirmed
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Eli Lilly

U.S.A
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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03

Eli Lilly

U.S.A
RDD
Not Confirmed
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Eli Lilly

U.S.A
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RDD
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5.5MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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04

Eli Lilly

U.S.A
RDD
Not Confirmed
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Eli Lilly

U.S.A
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RDD
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 9MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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05

Eli Lilly

U.S.A
RDD
Not Confirmed
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Eli Lilly

U.S.A
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RDD
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 14.5MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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Eli Lilly

U.S.A
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Eli Lilly

U.S.A
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.2MG BASE

Packaging :

Approval Date :

Application Number : 220934

Regulatory Info :

Registration Country : USA

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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.8MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

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02

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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

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03

RDD
Not Confirmed
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RDD
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5.5MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

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04

RDD
Not Confirmed
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RDD
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ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 9MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

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05

RDD
Not Confirmed
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RDD
Not Confirmed

ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 14.5MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

blank

06

RDD
Not Confirmed
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RDD
Not Confirmed

ORFORGLIPRON CALCIUM

Brand Name : FOUNDAYO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.2MG BASE

Approval Date :

Application Number : 220934

RX/OTC/DISCN :

RLD :

TE Code :

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 4385

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

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13 Nov 2025

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API | Excipient name

Orforglipron Calcium Hydrate

Synonyms

2212020-52-3, Ly3502970, Chembl4446782, Ly-3502970, 3-[(1s,2s)-1-[5-[(4s)-2,2-dimethyloxan-4-yl]-2-[(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4h-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4h-1,2,4-oxadiazol-5-one, 3-[(1s,2s)-1-(5-[(4s)-2,2-dimethyloxan-4-yl]-2-{(4s)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methyl-1h-indazol-5-yl)-2-oxo-2,3-dihydro-1h-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5h-pyrazolo[4,3-c]pyridine-5-carbonyl}-1h-indol-1-yl)-2-methylcyclopropyl]-1,2,4-oxadiazol-5(4h)-one

Cas Number

2212020-52-3

Unique Ingredient Identifier (UNII)

7ZW40D021M

Orforglipron Calcium Hydrate Manufacturers

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

Orforglipron Calcium Hydrate Suppliers

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

click here to find a list of Orforglipron Calcium Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Orforglipron Calcium Hydrate USDMF

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

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

click here to find a list of Orforglipron Calcium Hydrate suppliers with USDMF on PharmaCompass.

Orforglipron Calcium Hydrate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Orforglipron Calcium Hydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Orforglipron Calcium Hydrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Orforglipron Calcium Hydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Orforglipron Calcium Hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orforglipron Calcium Hydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Orforglipron Calcium Hydrate suppliers with NDC on PharmaCompass.

Orforglipron Calcium Hydrate GMP

Orforglipron Calcium Hydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Orforglipron Calcium Hydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Orforglipron Calcium Hydrate GMP manufacturer or Orforglipron Calcium Hydrate GMP API supplier for your needs.

Orforglipron Calcium Hydrate CoA

A Orforglipron Calcium Hydrate CoA (Certificate of Analysis) is a formal document that attests to Orforglipron Calcium Hydrate's compliance with Orforglipron Calcium Hydrate specifications and serves as a tool for batch-level quality control.

Orforglipron Calcium Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Orforglipron Calcium Hydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Orforglipron Calcium Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Orforglipron Calcium Hydrate EP), Orforglipron Calcium Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orforglipron Calcium Hydrate USP).

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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