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List Of DCGI-Approved Products In India - India's pharmaceutical industry is the largest industry globally, serves primarily the health needs of Indians, but now exports to almost 200 countries worldwide. As the sector grows it becomes even more important for credible and trusted regulation of drugs. The Drugs Controller General of India (DCGI) is the authority that regulates the vast and different sectors of the pharmacy profession through the Central Drugs Standard Control Organisation (CDSCO). If anyone is taking a medicine, vaccine, or medical device intended for use within India, it must first meet the safety, efficacy and quality assessments of the DCGI. The DCGI approval assures doctors, pharmacists, and patients that the respective product meets the structural scientific standards and is therefore safe to therapeutically use.
DCGI approved products has great respect. The meaning of such an approval is that it separates legitimate, researched products from unsafe or unverified products. The DCGI has approved thousands of products across varied health categories. Given the complexities and lengths in the drug treatment processes, healthcare professionals and businesses, as well as patients, should know what is meant by DCGI-approved products, so safe treatment can be promoted and to help protect against counterfeit or drug combinations. Below is more information on the list of DCGI-Approved Products in India that are avaliable for the use and treatment.
DCGI stand for Drug Control Controller General of India. Under the Ministry of Health and Family wellfare the DCGI heads the Central Drugs Standards Control Organisation. The setting of standards and Granting of approvals for the various categories of drugs, vaccines, or pharmaceutical product are done by these regulatory body. The DCGI are responsible for the quality, safety and efficacy of the products that are yet to be introduced in the market
The CDSCO operates in India through specialized division such as New Drugs, FDC (Fixed Dose Combinations), Biologics, Medical Devices & Diagnostics, Import & Registration, among others.
The DCGI approves the drug in three different categories these are based on the nature, uses and manufacturing of the drug , below is more information on it.
New Drugs
The New Drugs Division of CDSCO provides an official list of newly approved drugs that is updated once a year. This list gives you the most up to date look at the new therapies medicine that are approved by DCGI and are available in the market.
Fixed Dose Combinations (FDCs)
The FDC/New Drug Marketing Division approves the various FDCs. these medicinal combination are very commonly found in the Indian market, but require additional jumping through hoops and hurdles because of the potential risks with indiscriminate combinations.
Other Categories: Biologics, Vaccines, Medical Devices
DCGI approval applies to biologics, special biological products, vaccines and blood components/products and medical devices each of these products usually have their own specific approval tracks which appears to be avoided in descriptions and are through CDSCO lists, portals, communications and notifications.
Biophar life Sciences is one of the most trusted and reputed company that delivers DCGI approved products in the market. Biophar has a very large product portfolio and is preferred by most of the doctors and healthcare facilities. Biophar Life Sciences operates under ISO 9001:2015 certification and adheres to GMP–WHO standards to ensure the highest level of quality assurance.
Following are the list of exclusive products that are manufactured by Biophar are are DCGI approved :
SNO |
BRAND |
FORM |
COMPOSITION |
PACKING |
1 |
Feboxit-40 |
TABLET |
Febuxostat 40 mg |
10*10 Alu Alu |
2 |
Dapawalk-GM 10/1/500 |
TABLET |
Dapagliflozin 10 mg + Glimpride 1 mg + Metformin 500 mg ER |
10*10 Alu Alu |
3 |
Dapawalk-GM 10/2/500 |
TABLET |
Dapagliflozin 10 mg + Glimpride 2 mg + Metformin 500 mg ER |
10*10 Alu Alu |
4 |
Dydrolist 10 |
TABLET |
Dydrogesterone 10 mg |
10110 Blister |
5 |
Dydrolist 20 SR |
TABLET |
Dydrogesterone 20 mg SR |
10*10 Alu Alu |
6 |
Duoraft Plus |
TABLET |
Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg & Calcium Carbonate 187.5 mg (Chewable Tablet) |
10*9 Blister |
7 |
Ranolist |
TABLET |
Ranolazine Sr 500 mg |
10*10 Alu Alu |
8 |
Bilguard M |
TABLET |
Bilastine 20 mg + Montelukast 10 mg |
10*10 Alu Alu |
9 |
Vildalist DP 100/10 |
TABLET |
Vildagliptin 100 mg SR + Dapagliflozin 10 mg |
10*10 Alu Alu |
10 |
Ivabase-5 |
TABLET |
Ivabradine 5 mg |
10*10 Blister |
11 |
Sitawalk-D 100/10 |
TABLET |
Dapagliflozin 10 mg + Sitagliptin 100 mg |
10*10 Alu Alu |
12 |
Apixaref 5 |
TABLET |
Apixaban 5 mg |
10*10 Alu Alu |
13 |
Proninto |
TABLET |
Ticagrelor 90 mg |
10114 Blister |
14 |
Dapawalk M 1000 |
TABLET |
Dapagliflozin 10 mg + Metformin 1000 mg |
10*10 Alu Alu |
15 |
Subaitra SB 130 |
TABLET |
Itraconazole SB 130 mg |
10*10 Alu Alu |
16 |
Toflist |
OINTMENT |
Tofacitinib 2% w/w |
15 gm |
17 |
Dexfar BL |
SYRUP |
Bilastine 3.3 mg + Dextromethorphan Hydrobromide 10 mg + Phenylephrine 5 mg |
100 ml |
18 |
Youphar |
TABLET |
Iron 30 mg + Zinc 10 mg + Folic Acid 1.5 mg + Vitamin B12 15 mcg |
10*15 Alu Alu |
19 |
Dapawalk-10 |
TABLET |
Dapagliflozin 10 mg |
10*10 Alu Alu |
20 |
Vildalist-DM-1000 |
TABLET |
Vildagliptin 100 mg + Dapagliflozin 10 mg + Metformin 1000 mg |
10*10 Alu Alu |
21 |
Vildalist-DM-500 |
TABLET |
Vildagliptin 100 mg + Dapagliflozin 10 mg + Metformin 500 mg |
10*10 Alu Alu |
22 |
Vildalist-DP-100/10 |
TABLET |
Vildagliptin 100 mg SR + Dapagliflozin 10 mg |
10*10 Alu Alu |
23 |
Sitawalk-50/1000 |
TABLET |
Sitagliptin 50 mg + Metformin 1000 mg |
10115 Blister |
24 |
Sitawalk-50/500 |
TABLET |
Sitagliptin 50 mg + Metformin 500 mg |
10115 Blister |
25 |
Sitawalk-M 100/500 PR |
TABLET |
Sitagliptin 100 mg + Metformin 500 mg |
10*10 Alu Alu |
26 |
Sitawalk-D 100/10 |
TABLET |
Dapagliflozin 10 mg + Sitagliptin 100 mg |
10*10 Alu Alu |
27 |
Sitawalk-DM-1000 |
TABLET |
Dapagliflozin 10 mg + Metformin 1000 mg + Sitagliptin 100 mg |
10*10 Alu Alu |
28 |
Sitawalk-DM-500 |
TABLET |
Dapagliflozin 10 mg + Metformin 500 mg + Sitagliptin 100 mg |
10*10 Alu Alu |
29 |
Sitawalk-100 |
TABLET |
Sitagliptin 100 mg |
1017 Blister |
30 |
Sitawalk-50 |
TABLET |
Sitagliptin 50 mg |
1017 Blister |
31 |
Rawheal |
GEL |
— |
50 gm |
32 |
Vildalist-P |
TABLET |
Vildagliptin 50 mg + Pioglitazone 15 mg |
10*10 Alu Alu |
33 |
Mepride-PG1 |
TABLET |
Glimepiride 1 mg + Metformin HCl 500 mg SR + Pioglitazone 15 mg |
10*10 Alu Alu |
34 |
Mepride-PG2 |
TABLET |
Glimepiride 2 mg + Metformin HCl 500 mg SR + Pioglitazone 15 mg |
10*10 Alu Alu |
35 |
Mypride-M1 |
TABLET |
Glimepiride 1 mg + Metformin HCl 500 mg SR |
10*10 Blister |
36 |
Mypride-M2 |
TABLET |
Glimepiride 2 mg + Metformin HCl 500 mg SR |
10*10 Blister |
37 |
Mypride-M1-1000 |
TABLET |
Glimepiride 1 mg + Metformin HCl 1000 mg |
10*10 Blister |
38 |
Mypride-M2-1000 |
TABLET |
Glimepiride 2 mg + Metformin HCl 1000 mg |
10*10 Blister |
39 |
Emprace-10 |
TABLET |
Empagliflozin 10 mg |
10*10 Blister |
40 |
Emprace-25 |
TABLET |
Empagliflozin 25 mg |
10*10 Blister |
THe DCGI Approval is a very regulating way of approving the products thye classification of the drugs in to various categories helps the public to understand the nature of the medicine and protect the health of the patient. This blog of List Of DCGI-Approved Products In India contains all the information and the list of DCGI approved product manufatcured by Biophar Life Science that are available in the market.. DCGI is a very important and crucial if your business is related to healthcare products. It ensure that the product is safe for use and help in gaining trust of market and customers.
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