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Tag: Pharma Info

For disposable insulin glargine 100 IU/ml pens, the NPPA establishes a specific price ceiling.

April 5, 2023
After taking into account the arguments made by Sanofi India Ltd, the Organization of Pharmaceutical Producers of India…

For further investigation, CDSCO requests information on 16 FDCs that Prof. Kokate’s committee identified as being illogical.

April 5, 2023
All makers of the 16 fixed dose combinations (FDCs) that were previously deemed to be illogical in a…

Pilot testing by NITI Aayog and TBCT of the blood transfusion infrastructure in Uttar Pradesh shows 37% better performance.

April 4, 2023
According to a pilot study conducted by NITI Aayog and Terumo Blood and Cell Technologies (TBCT), the public-private…

ORDI calls on the government to simplify the documentation process for imported medications exempt from customs duties.

April 4, 2023
The Organisation of Rare Diseases of India (ORDI) now argues that the Union government would need to simplify…

For Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, Glenmark Pharmaceuticals receives ANDA approval.

April 3, 2023
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine®1 Tablets, 5 mg and…

Hutchmed has finished rolling-in its NDA for the treatment of refractory metastatic colorectal cancer to the US FDA.

April 3, 2023
Hutchmed (China) Limited reports that it has finished the rolling submission of a New Drug Application (NDA) to…

Pharmacopoeia standards for medications used in Ayurveda, Siddha, Unani, and homoeopathy will shortly be developed by PCIM&H.

April 3, 2023
The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon start developing pharmacopoeia standards for the Ayurvedic,…

Cabaletta Bio’s IND application for CABA-201 to treat systemic lupus erythematosus has been approved by the US FDA.

April 3, 2023
The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a…

Imlifidase phase 2 study enrolment by Hansa Biopharma for patients with Guillain-Barré syndrome is already complete.

April 2, 2023
The phase 2 recruitment for Hansa Biopharma’s imlifidase research in Guillain-Barré syndrome has been completed, according to the…

The Delhi High Court rejects Boehringer Ingelheim’s request for a temporary restraining order, and generic linagliptin production is permitted.

April 2, 2023
In a patent dispute involving the former’s diabetes drug linagliptin, a single judge of the Delhi High Court…

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