Page 149 - CW E-Magazine (7-11-2023)

Pharmaceuticals

DRUG INTERMEDIATE

Sadhana Nitro gets eco nod for manufacture of

paracetamol ingredient

Sadhana Nitro Chem Ltd. has fl uctuated between Rs. 350 per kilo to
announced the receipt of approval from Rs. 700 per kilo, he said, indicating
Maharashtra Pollution Control Board that higher local production could help
(MPCB) for consent to establish the stabilise prices.
production of para-aminophenol (pAP),
a key ingredient that goes into produc- This is the Rs. 147-crore specia-
tion of paracetamol. The company lity chemicals company’s largest foray
announced the successful transition into pharmaceuticals. It was awarded
to commercial production at the pAP due to its detrimental effects. In con- a contract under the government’s PLI
plant, which is now operating in con- trast, the nitrobenzene method avoids scheme to make 36,000 tonnes of pAP
tinuous mode. use of any chlorine-based ingredients, (2021). Manufacture & Exports
ensuring a product free from PCA SODIUM HYPOCHLORITE
(4%, 6%, 8%, 10%, 12%)
The company said the development and other harmful impurities,” the Globally, there is a growing need  Iodophor 1% or 6%
will make it only the second in the company said in a fi ling to the stock for pAP that is free of chlorine impu-  Liquid Detergent (Soap) Concentrate
 Brown Phenyl
world to make pAP from nitrobenzene. exchange. rities, he said. The global requirement  Hydrochloric Acid A.R., L.R., C.P. Grade
The other company that makes the drug is estimated at between 1.60 to 2-lakh  Sulphuric Acid A.R., L.R., C.P. Grade
intermediate is multinational Mallinck- The company’s initial projection tonnes annually, he said, while India  Nitric Acid A.R., L.R., C.P. Grade
 Per Acetic Acid 4%
rodt Pharmaceuticals. was to start production by March 2022, imports about 50,000 tonnes. And prices Also F.D.A. Approved Products
“but unforeseen regulatory constraints fluctuate when there are pollution
“Producing pAP from nitroben- posed an initial delay,” it said. The concerns or geo-political tensions,  Sodium Hypochlorite U.S.P. Grade 4% w/v
 Sodium Hypochlorite B.P. Grade 8% w/v
zene, as against its manufacture from development will assure high-quality Mr. Javeri said.  Hydrogen Peroxide I.P. Grade 6%
 Hydrogen Peroxide B.P. Grade 30%, 35%
Para Nitro Chloro Benzene (PNCB), indigenous supply of pAP that is free of  Black Phenyl 5 to 7 R.W.C. I.P. Grade
offers signifi cant benefi ts. The PNCB impurities, said Mr. Abhishek Javeri, With a capacity of over 3,000 tonnes ALSO JOB WORK FOR DISINFECTANT PRODUCTS
method is marked by substantial effl u- Managing Director of the company, currently, the company is planning to NIKISHA Chemicals Pvt. Ltd.
ent production, while the nitrobenzene was quoted as saying in news reports. scale up to tap the global opportunity Regd. Off. & Works: Kalpana Udhyog, Plot No. 74, Road No. 2,
approach aligns with green chemistry as well. Responding to why others were Sector 1/S, New Panvel 410 206, Raigad, Maharashtra.
Tel.: 022-27453996 * Telefax: 27464572
principles, generating zero effl uent. About 80 percent of pAP is sourced not adopting similar cleaner techno- Mob.: 9820155320 / 9833105320
Notably, the PNCB process results in from China, said Mr. Javeri, pointing logies, he said it required high quality Email: nikisha.nilesh@gmail.com
various chlorine-based contaminants, to industry concerns on dependence nitrobenzene, which they had been
notably Para Chloro Aniline (PCA), a and price fl uctuations. In the last two making since 1975, and it involved a SINCE 1970: Pioneers in Chromatography Leaders in Quality Aluminium Stearate (All Grades)

substance facing increasing restrictions years, the price of this raw material has more diffi cult chemistry, he added. CASTOR OIL DERIVATIVES CHROMATOGRAPHIC CHEMICALS Calcium Stearate
 Undecylenic Acid  Silica Gel for TLC & Column Zinc / Mg / Sodium Stearate
INSPECTION REPORT  Methyl Undecylenate Chromatography (Various Mesh Sizes) Sodium Pentachlorophenate
 Heptaldehyde  Aluminium Oxide for Column P.E. Wax
Contact Manufacturer:
Dr. Reddy’s Labs’ formulations unit in Hyderabad  Zinc Undecylenate Chromatography (Acidic, Basic & Neutral) R.T. INDUSTRIES
 Calcium Undecylenate  Lipids for GLC “Harmony”, B-1402, Siddheshwar Gardens, Dhokali,
Kolshet Road, Thane (West) - 400 607.
gets 10 US FDA observations  Undecanoic Acid Telefax: 022-25892134 * Mob.: 9821008427 / 9819879421
 Heptyl Alcohol
A formulations manufacturing pally near Hyderabad. The inspection fi c pre-approval inspection of the com-  Heptanoic Acid HIGH PURITY LIPIDS / Email: rtindust112@rediffmail.com
 Methyl Ricinoleate
SPECIALITY FATTY ACIDS / DERIVATIVES
facility of Dr. Reddy’s Laboratories was conducted from October 19-27, pany’s biologics manufacturing facil-  Other Salts and Esters  Arachidic Acid 99% Min. Purity by GC For your requirement oF
(DRL) in Hyderabad has been issued a and a Form 483 with 10 observations ity in Bachupally. Through Form 483, of Undecylenic Acid  Oleic Acid 99% Min. Purity by GC LIqUID BROMINE
Form 483 with 10 observations by the issued, which the company said it will the regulator notifi es the company’s  Alcohol C-11 Undecylenic  Linoleic Acid 99% Min. Purity by GC Virgin & Recovered
 Zinc Ricinoleate
US FDA. address within the stipulated timeline. management of objectionable condi-  Glycerol Mono Undecylenate  Sodium Caprylate 98% Min. Purity by GC PVC RESIN (K-57, K-65-67)
tions observed by its investigators that  Glycerol Mono Caprylate  Salts and Esters of these Fatty Acids
Please contact:
The observations were issued on Earlier in October, DRL was issued may constitute violations of the Food Mangleshwar CheMiCals
completion of a routine cGMP inspec- a Form 483 with nine observations by Drug and Cosmetic Act and related ACME SYNTHETIC CHEMICALS Mumbai
tion of the facility (FTO-3) in Bachu- the US FDA following a product speci- Acts. Contact: +91 98332 60962 Mobile: +91 9004585240
Email: acme@acmechem.com  Web.: www.acmechem.com mangleshwarchemicals@gmail.com
18/15
148 Chemical Weekly November 7, 2023 Chemical Weekly November 7, 2023 149

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