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Chemistry

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Also known as: 551-16-6, 6-apa, Penicin, Penin, Aminopenicillanic acid, 6-aps
Molecular Formula
C8H12N2O3S
Molecular Weight
216.26  g/mol
InChI Key
NGHVIOIJCVXTGV-ALEPSDHESA-N
FDA UNII
QR0C4R7XVN

6-Aminopenicillanic Acid
1 2D Structure

6-Aminopenicillanic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
2.1.2 InChI
InChI=1S/C8H12N2O3S/c1-8(2)4(7(12)13)10-5(11)3(9)6(10)14-8/h3-4,6H,9H2,1-2H3,(H,12,13)/t3-,4+,6-/m1/s1
2.1.3 InChI Key
NGHVIOIJCVXTGV-ALEPSDHESA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)N)C(=O)O)C
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)N)C(=O)O)C
2.2 Other Identifiers
2.2.1 UNII
QR0C4R7XVN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6-apa Cpd

2. Aminopenicillanic Acid

3. Aminopenicillanic Acid, Potassium Salt

4. Aminopenicillanic Acid, Sodium Salt

2.3.2 Depositor-Supplied Synonyms

1. 551-16-6

2. 6-apa

3. Penicin

4. Penin

5. Aminopenicillanic Acid

6. 6-aps

7. (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

8. Phenacyl 6-aminopenicillinate

9. 6-aminopenicillamine Acid

10. (+)-6-aminopenicillanic Acid

11. 6-aminopenicillanate

12. Ai3-52557

13. Chebi:16705

14. 6-amino-penicillanic Acid

15. Mfcd00005176

16. Qr0c4r7xvn

17. 6beta-aminopenicillanic Acid

18. (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptan-2-carbonsaeure

19. Chembl1236749

20. 6-amino-2,2-dimethylpenam-3alpha-carboxylic Acid

21. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-amino-3,3-dimethyl-7-oxo-, (2s,5r,6r)-

22. Sr-01000640154-1

23. 6-aminopenicillanicacid

24. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 6-amino-3,3-dimethyl-7-oxo-, (2s,5r,6r)-

25. Einecs 208-993-4

26. Unii-qr0c4r7xvn

27. Nsc 50071

28. Nsc-50071

29. Ncgc00160198-01

30. (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid

31. (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (6-aminopenicillanic Acid)

32. Amino Penicillanic Acid

33. 6-aminopenicillanic-acid

34. 6-aminopenici Llanic Acid

35. Bmse000312

36. Epitope Id:117703

37. Ec 208-993-4

38. Dsstox_cid_26097

39. Dsstox_rid_81336

40. Dsstox_gsid_46097

41. Schembl66332

42. Amoxicillin Related Compound A

43. Dtxsid7046097

44. 09070_fluka

45. 6-aminopenicillinic Acid (6-apa)

46. Bcp13375

47. Str03060

48. Zinc3860188

49. Tox21_111749

50. Bdbm50420257

51. Ccg-50809

52. S5035

53. (+)-6-aminopenicillanic Acid, 96%

54. 6-aminopenicillanic Acid [mi]

55. Akos015907713

56. Cs-w014265

57. Hy-w013549

58. Ks-5277

59. S12351

60. Ac-11282

61. Cas-551-16-6

62. Ampicillin Impurity A [ep Impurity]

63. Piperacillin Sodium Impurity H [ep]

64. A0800

65. Amoxicillin Related Compound A [usp-rs]

66. C02954

67. (+)-6-aminopenicillanic Acid, Analytical Standard

68. A830497

69. Sulbactam Sodium Impurity B [ep Impurity]

70. Amoxicillin Sodium Impurity A [ep Impurity]

71. Cloxacillin Sodium Impurity C [ep Impurity]

72. Q2823234

73. W-105586

74. 6beta-amino-2,2-dimethylpenam-3alpha-carboxylic Acid

75. Amoxicillin Related Compound A [usp Impurity]

76. Amoxicillin Trihydrate Impurity A [ep Impurity]

77. Ampicillin Trihydrate Impurity A [ep Impurity]

78. Dicloxacillin Sodium Impurity C [ep Impurity]

79. Benzylpenicillin Sodium Impurity A [ep Impurity]

80. Phenoxymethylpenicillin Impurity C [ep Impurity]

81. Z1741972222

82. (3s,5r,6r)-6-amino-2,2-dimethylpenam-3-carboxylic Acid

83. Benzylpenicillin Potassium Impurity A [ep Impurity]

84. (3s, 5r, 6r)-6-amino-2,2-dimethylpenam-3-carboxylic Acid

85. Oxacillin Sodium Monohydrate Impurity A [ep Impurity]

86. Phenoxymethylpenicillin Potassium Impurity C [ep Impurity]

87. Flucloxacillin Impurity C, European Pharmacopoeia (ep) Reference Standard

88. (2s)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

89. Amoxicillin Related Compound A, United States Pharmacopeia (usp) Reference Standard

90. (2s,5r,6r)-(+)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

91. (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid

92. [2s-(2alpha,5alpha,6beta)]-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

93. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 6-amino-3,3-dimethyl-7-oxo-, (2s,6r)-

94. 6-apa (2s,5r,6r)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Penicin Penin

95. Rel-(2r,6s)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

96. X1e

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 216.26 g/mol
Molecular Formula C8H12N2O3S
XLogP3-2.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count1
Exact Mass216.05686342 g/mol
Monoisotopic Mass216.05686342 g/mol
Topological Polar Surface Area109 Ų
Heavy Atom Count14
Formal Charge0
Complexity318
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

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Submission : 1968-06-10

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NDC API

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6-AMINOPENICILLANIC ACID

NDC Package Code : 59651-991

Start Marketing Date : 2024-08-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

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6-AMINOPENICILLANIC ACID

NDC Package Code : 32903-045

Start Marketing Date : 2005-03-10

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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6-AMINOPENICILLANIC ACID

NDC Package Code : 55657-100

Start Marketing Date : 2005-03-31

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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6-AMINOPENICILLANIC ACID

NDC Package Code : 52115-000

Start Marketing Date : 2013-06-24

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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6-Aminopenicillanic Acid

About the Company : CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken ...

CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken “All for better medicine, all for a healthier world” as its corporate mission. In all aspects of development, procurement, production, and distribution, they are committed to ensuring the health of people by creating high-quality, effective, reliable, and innovative drugs that meet the needs of society.
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API Reference Price

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HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"M\/S","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"14080.00","actualQuantity":"14080","unit":"KGS","unitRateFc":"42","totalValueFC":"598760.9","currency":"USD","unitRateINR":"3563.7","date":"03-Sep-2024","totalValueINR":"50176896","totalValueInUsd":"598760.9","indian_port":"JNPT","hs_no":"29411050","bill_no":"5393245","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ZHEJIANG UEASY BUSINESS SERVICES CO ., LTD ROOM 302 NO 22 CHANGCHENG ST REET GONGSHU DIST Hangzhou, , CHINA CHINA CHINA","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"202\/C, SAI DHAM CO-OP. HSG. 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SOC.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"308 EXIM LINK OPP INDIRA CONTAINER","city":"MUMBAI,MAHARASHTRA","supplier":"M\/S","supplierCountry":"CHINA","foreign_port":"NINGBO","customer":"DPB PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"4400.00","actualQuantity":"4400","unit":"KGS","unitRateFc":"39","totalValueFC":"172742.4","currency":"USD","unitRateINR":"3313.1","date":"07-Nov-2024","totalValueINR":"14577420","totalValueInUsd":"172742.4","indian_port":"JNPT","hs_no":"29411050","bill_no":"6537012","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NINGBO","supplierAddress":"ZHEJIANG CHEMICALS IMPORT & EXPORT CORPORATION NO 37, QINGCHUN ROAD, H ANGZHOU , , CHINA CHINA","customerAddress":"308 EXIM LINK OPP INDIRA CONTAINER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"E-11,INDUSTRIAL AREA","city":"PANIPAT","supplier":"HARBIN YUYANG IMP.\/EXP CO., LTD","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"LABORATE PHARMACEUTICALS INDIA ","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"37","totalValueFC":"747995.7","currency":"USD","unitRateINR":"3156.1","date":"16-Nov-2024","totalValueINR":"63122000","totalValueInUsd":"747995.7","indian_port":"JNPT","hs_no":"29411050","bill_no":"6708791","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"OFFICE BUILDING, QUJIAN ROAD EAST, RENHE WOOD INDUSTRY NORTH, LIMIN DE VELOPMENT ZONE, HARBIN CITY, HEILON China","customerAddress":"E-11,INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"E-11,INDUSTRIAL AREA","city":"PANIPAT","supplier":"MOHAWK CHEMICALS TRADING - FZCO","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"LABORATE PHARMACEUTICALS INDIA ","customerCountry":"INDIA","quantity":"40000.00","actualQuantity":"40000","unit":"KGS","unitRateFc":"40","totalValueFC":"1617288","currency":"USD","unitRateINR":"3412","date":"16-Nov-2024","totalValueINR":"136480000","totalValueInUsd":"1617288","indian_port":"JNPT","hs_no":"29411050","bill_no":"6707881","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"IFZA BUSINESS PARK, DDP, PREMISES N UMBER 38510-001, DUBAI SILICONE OAS IS, DUBAI United Arab Emirates","customerAddress":"E-11,INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"E-11,INDUSTRIAL AREA","city":"PANIPAT","supplier":"ZHEJIANG MEDICINE CO LTD","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"LABORATE PHARMACEUTICALS INDIA ","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"39","totalValueFC":"394214","currency":"USD","unitRateINR":"3326.7","date":"16-Nov-2024","totalValueINR":"33267000","totalValueInUsd":"394214","indian_port":"JNPT","hs_no":"29411050","bill_no":"6711728","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"RT CO., LTD. 6-7\/F, 310 NORTH ZHONG SHAN ROAD, HANGZHOU, 310003 CHINA SDNF China","customerAddress":"E-11,INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"202\/C, SAI DHAM CO-OP. HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"M\/S","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"3040.00","actualQuantity":"3040","unit":"KGS","unitRateFc":"40","totalValueFC":"122985.9","currency":"USD","unitRateINR":"3414","date":"25-Nov-2024","totalValueINR":"10378560","totalValueInUsd":"122985.9","indian_port":"JNPT","hs_no":"29411050","bill_no":"6861741","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"ZHEJIANG MEDICINES & HEALTH PRODUCT S IMPORT & EXPORT CO LTD 6-7\/F, 310 NORTH ZHONGSHAN ROAD, HANGZHOU CHINA","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"6-AMINOPENICILLANIC ACID (6-APA)","address":"202\/C, SAI DHAM CO-OP. HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"M\/S","supplierCountry":"CHINA","foreign_port":"NINGBO","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"39","totalValueFC":"394445","currency":"USD","unitRateINR":"3328.7","date":"25-Nov-2024","totalValueINR":"33286500","totalValueInUsd":"394445","indian_port":"JNPT","hs_no":"29411050","bill_no":"6861034","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NINGBO","supplierAddress":"ZHEJIANG MEDICINES & HEALTH PRODUCT S IMPORT & EXPORT CO LTD 6-7\/F, 310 NORTH ZHONGSHAN ROAD, HANGZHOU CHINA","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"}]
17-Jan-2021
25-Nov-2024
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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s 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. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

Impressions: 6627

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

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6-Aminopenicillanic Acid Manufacturers

A 6-Aminopenicillanic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 6-Aminopenicillanic Acid, including repackagers and relabelers. The FDA regulates 6-Aminopenicillanic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 6-Aminopenicillanic Acid 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 6-Aminopenicillanic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

6-Aminopenicillanic Acid Suppliers

A 6-Aminopenicillanic Acid supplier is an individual or a company that provides 6-Aminopenicillanic Acid active pharmaceutical ingredient (API) or 6-Aminopenicillanic Acid finished formulations upon request. The 6-Aminopenicillanic Acid suppliers may include 6-Aminopenicillanic Acid API manufacturers, exporters, distributors and traders.

click here to find a list of 6-Aminopenicillanic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

6-Aminopenicillanic Acid USDMF

A 6-Aminopenicillanic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 6-Aminopenicillanic Acid active pharmaceutical ingredient (API) in detail. Different forms of 6-Aminopenicillanic Acid DMFs exist exist since differing nations have different regulations, such as 6-Aminopenicillanic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 6-Aminopenicillanic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. 6-Aminopenicillanic Acid USDMF includes data on 6-Aminopenicillanic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 6-Aminopenicillanic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 6-Aminopenicillanic Acid suppliers with USDMF on PharmaCompass.

6-Aminopenicillanic Acid 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 6-Aminopenicillanic Acid as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 6-Aminopenicillanic Acid 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 6-Aminopenicillanic Acid 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 6-Aminopenicillanic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 6-Aminopenicillanic Acid NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 6-Aminopenicillanic Acid suppliers with NDC on PharmaCompass.

6-Aminopenicillanic Acid GMP

6-Aminopenicillanic Acid 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 6-Aminopenicillanic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 6-Aminopenicillanic Acid GMP manufacturer or 6-Aminopenicillanic Acid GMP API supplier for your needs.

6-Aminopenicillanic Acid CoA

A 6-Aminopenicillanic Acid CoA (Certificate of Analysis) is a formal document that attests to 6-Aminopenicillanic Acid's compliance with 6-Aminopenicillanic Acid specifications and serves as a tool for batch-level quality control.

6-Aminopenicillanic Acid CoA mostly includes findings from lab analyses of a specific batch. For each 6-Aminopenicillanic Acid 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.

6-Aminopenicillanic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (6-Aminopenicillanic Acid EP), 6-Aminopenicillanic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (6-Aminopenicillanic Acid 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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