Generic drug manufacturing on rebound; FDA witnesses uptick in facility registrations

Generic drug manufacturing on rebound; FDA witnesses uptick in facility registrations

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By Team PharmaCompass

2020-11-26View: 68980

Generic drug manufacturing on rebound; FDA witnesses uptick in facility registrations

Covid-19 has brought a lot of businesses to a grinding halt. However, this is not the case for pharmaceutical manufacturing, which is drawing a lot of attention from across the world. The pandemic has had a positive impact on the pharmaceutical industry.

After years of witnessing a steady decline in generic drug manufacturing facility registrations with the US Food and Drug Administration (FDA), it seems that in 2021 the numbers will once again witness an increase, albeit marginally.

This week, PharmaCompass analyzed the FDA database of facilities that have paid the user fee under the Generic Drug User Fee Act (GDUFA). We found that as of the middle of November, the number of facilities that are able to supply generic drugs to the US is only slightly lower than the previous year. However, some facilities, which have a historical track record of registering with the FDA, are yet to register. Therefore, we believe that by the end of this year, the final number of facilities registered should be higher than that in 2020.

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)


Increase in ANDA fees led to drop in registrations

The Generic Drug User Fee Act (GDUFA) came into effect on October 1, 2012. The law mandated all firms that manufactured human generic drug products and active pharmaceutical ingredients (APIs) for human generic drug products, distributed in the US, to be subject to FDA’s user fees. Five years after the passage of the original law, on August 18, 2017, the GDUFA was reauthorized (as GDUFA II), with provisions that came into effect on October 1, 2017. These provisions will remain in effect until September 30, 2022.

minakem-m-2021-04-19

GDUFA II fees varied significantly from those in GDUFA I, due to two fundamental adjustments made to the fee structure:

1. The revenue base for GDUFA II was increased to US$ 493.6 million from US$ 323 million in the final year of GDUFA I. The reason for this increase was the fact that generic drug applications — or Abbreviated New Drug Applications (ANDAs), which are the primary workload driver of the program – increased over the first four years of GDUFA I. ANDA submissions to the FDA were anticipated to be 750 ANDAs per year. However, they increased to an average of around 1,000 per year in the first four years of GDUFA I. To address the increased workload, the FDA had to hire additional staff. GDUFA II’s revenue base factored in these additional costs. 

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)

2. GDUFA II is designed to rely on annual program fees, which would shift the fee burden somewhat from facility fees. As a result, while the facility fees remained relatively unchanged or even reduced in some cases, the fee for ANDAs saw an increase of more than US$ 100,000 per application.

Generic Drug User Fee Act (GDUFA) (in US$)

2021

2020

2017

Abbreviated New Drug Application (ANDA)

196,868

176,237

70,480

Drug Master File (DMF)

69,921

57,795

51,140

Finished Dosage Form Facility (Domestic)

184,022

195,662

258,646

Finished Dosage Form Facility (Foreign)

199,022

210,662

273,647

Active Pharmaceutical Ingredient Facility (Domestic)

41,671

44,400

44,234

Active Pharmaceutical Ingredient Facility (Foreign)

56,671

59,400

59,234

Contract Manufacturing Organization (CMO) – Domestic

61,341

65,221

Not Applicable

Contract Manufacturing Organization (CMO) – Foreign

76,341

80,221

Not Applicable

 

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)

Although the facility fees have effectively remained unchanged from GDUFA I to GDUFA II, the significant increase in ANDA fees resulted in nearly a 17 percent reduction in facilities which paid their user fees for 2018. The number of facility registrations have witnessed a marginal decline ever since, although there is reason to believe that the bottom has been reached.

Fiscal Year

Facility Registrations

2013

1390

2014

1414

2015

1450

2016

1425

2017

1442

2018

1269

2019

1286

2020

1300

2021

1287

 

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)


India continues to top API facilities share

Consistent with the trends seen in previous years, we found that of the 1,287 facilities that paid their user fees, a little over half (51 percent, or 655 facilities) are API manufacturers, 30 percent (or 389) manufacture finished dosage forms (FDFs), 67 facilities produce both APIs and FDFs and there are another 176 sites that offer contract manufacturing services.

Facility Payment Type

Total

API

655

BOTH

67

CMO

176

FDF

389

Grand Total

1287


At 183, India continues to have the largest share of API facilities, which nearly equals the sites of China (101) and the United States (88) combined. In Europe, Italy leads with 57 API manufacturing sites followed by Germany and Spain, that have 29 and 28 API facilities, respectively.

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)

For FDFs of human generic drug products, the largest number of facilities are in the United States (164 sites), followed by India (113) and China (34).

Country

API

BOTH

CMO

FDF

Total

United States

88

14

82

164

348

India

183

19

12

113

327

China

101

11

9

34

155

Italy

57

2

15

3

77

Germany

29

2

13

3

47

Spain

28

1

5

6

40

Canada

8

 

7

18

33

France

17

2

8

1

28

Switzerland

17

 

5

3

25

Taiwan

10

5

4

5

24

Japan

17

1

   

18

United Kingdom

11

1

1

1

14

Mexico

10

   

1

11

Ireland

5

 

2

3

10

Israel

5

1

 

4

10

 

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)


Our view

The Covid crisis led to a surge in demand for APIs and generic drugs, which highlighted the global dependence on India and China for these drugs. The generic facility registrations reveal that almost 38 percent (482 out of 1287) of the facilities registered with the FDA are located in these two countries.

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India, a prominent API manufacturer, admitted to its own extreme dependence on China for APIs and intermediates. In July this year, India announced guidelines for its schemes for the development of bulk drugs and medical device parks across the country. These schemes are part of Indias self-reliance campaign.

Similar reshoring initiatives have been announced by the United StatesFrance and Japan, and many other countries that want to reduce their reliance on foreign manufacturers for essential drugs.

While shifting supply chains is certainly a long drawn out process, the wheels have definitely started to turn. This should lead to new generic drug manufacturing facilities registering with the FDA in the future.

Generic Drug Facilities Registered with the USFDA in FY 2021 (Free Excel Available)

 

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Image Credit : Generic-Drug-Facility-Registrations-with-USFDA by PharmaCompass is licensed under CC BY 2.0

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