Research Report on Niacinamide - China

Research Report on Niacinamide - China

 Table of Contents

1. Basic Information

2. Chinese market listing Status

(1) Import Status

(2) Generic Drug Approval

(3) Consistency Evaluation Application and Approval Status

(4) Generic Drug Application Status

3.  Reference Preparation

4. Market Situation

5. Medical Insurance Status

6. Centralized Procurement Status

7. Sales Status

8. Winning Bid Price

9. Active Pharmaceutical Ingredient Information

10. Active Pharmaceutical Ingredient Pharmacopeia Information

11. Active Pharmaceutical Ingredient Filing Information

1.Basic Information

Nicotinamide (Nicotinamide), also known as niacinamide, is the amide derivative of vitamin B3. It is a key component of coenzyme I and coenzyme II, involved in various oxidation-reduction reactions in the body, crucial for the metabolism and energy cycle of fats, proteins, and carbohydrates. It is widely used in beverages, food, daily chemicals, and pharmaceuticals. Unlike niacin, nicotinamide has better water solubility and no significant vasodilation effect, and is used clinically to treat niacin deficiency-related pellagra and other heart-related conditions.

Currently, in China, available nicotinamide formulations include tablets, injections, and glucose injection solutions. Although a company has applied for a reference preparation filing for nicotinamide injection, it has not passed the review (as shown in Table 1-1), and no other formulations have reference filings.

Table 1-1 Nicotinamide Injection Reference Preparation

2. Domestic Listing Status

2.1 Import Status

As of August 27, no nicotinamide preparations have been imported into China.

2.2 Generic Drug Approvals

As of August 27, there are 13 approvals for nicotinamide injection, 36 for nicotinamide tablets, 2 for nicotinamide glucose injection, and 3 for nicotinamide injection powder.

2.3 Consistency Evaluation Status

As of August 27, no nicotinamide preparations have passed or been deemed to have passed the consistency evaluation, nor has any company applied.

2.4 Generic Drug Applications

As of August 27, no company has submitted a listing application for nicotinamide preparations under the 2016 chemical drug registration regulations. 

3.Reference Preparation

As shown in Table 1-1, the review of the reference preparation for nicotinamide injection was not approved, and no other dosage forms have had reference preparation applications submitted.

4. Market Situation

4.1 Medical Insurance Status

Nicotinamide injection, tablets, and injectable powder are all Category B under the national medical insurance system, and nicotinamide tablets are also classified as Category A OTC drugs. Nicotinamide glucose injection is not covered by medical insurance.

4.2 Centralized Procurement Status

No nicotinamide preparations are listed in the national centralized procurement catalog.

4.3 Sales Status

The primary sales channel for nicotinamide preparations is through hospitals.

Table 4-1 Sales of Nicotinamide Preparations in Hospitals Nationwide (in billion yuan)